Social Skills Training for Children and Adolescents With Autism Spectrum Disorder:
A Randomized Controlled Trial
Nora Choque Olsson,
PhD, Oskar Flygare,
BSc, Christina Coco,
MSc, Anders G€orling,
MSc, Anna Råde,
MSc, Qi Chen,
MD, PhD, Katarina Lindstedt,
MSc, Steve Berggren,
MSc,
Eva Serlachius,
MD, PhD, Ulf Jonsson,
PhD, Kristiina Tammimies,
PhD, Lars Kjellin,
PhD, Sven B€olte,
PhDObjective: Social skills group training (SSGT) for children and adolescents with autism spectrum disorder (ASD) is widely applied, but effectiveness in real-world practice has not yet been properly evaluated. This study sought to bridge this gap.
Method: This 12-week pragmatic randomized controlled trial of SSGT compared to standard care alone was con- ducted at 13 child and adolescent psychiatry outpatient units in Sweden. Twelve sessions of manualized SSGT (“KONTAKT”) were delivered by regular clinical staff.
Participants (N ¼ 296; 88 females and 208 males) were children (n ¼ 172) and adolescents (n ¼ 124) aged 8 to 17 years with ASD without intellectual disability. The pri- mary outcome was the Social Responsiveness Scale rating by parents and blinded teachers. Secondary outcomes included parent- and teacher-rated adaptive behaviors, trainer-rated global functioning and clinical severity, and self-reported child and caregiver stress. Assessments were made at baseline, posttreatment, and 3-month follow-up.
Moderator analyses were conducted for age and gender.
Results: Significant treatment effects on the primary outcome were limited to parent ratings for the adolescent
subgroup (posttreatment: –8.3; 95% CI ¼ –14.2 to –1.9;
p ¼ .012, effect size [ES] ¼ 0.32; follow-up: –8.6;
95% CI ¼ –15.4 to –1.8; p ¼ .015, ES ¼ 0.33) and females (posttreatment: –8.9; 95% CI ¼ –16.2 to –1.6;
p ¼ .019, ES ¼ 0.40). Secondary outcomes indicated moderate effects on adaptive functioning and clinical severity.
Conclusion: SSGT for children and adolescents with ASD in regular mental health services is feasible and safe.
However, the modest and inconsistent effects underscore the importance of continued efforts to improve SSGT beyond current standards.
Clinical trial registration information: Social Skills Group Training (“KONTAKT”) for Children and Adolescent With High-functioning Autism Spectrum Disorders;
https://clinicaltrials.gov/; NCT01854346.
Key words: autism spectrum disorder, treatment, inter- vention, gender, adolescence
J Am Acad Child Adolesc Psychiatry 2017;56(7):585–592.
T he prevalence of autism spectrum disorder (ASD) is about 1% among children and adolescents in high- income countries.1ASD affects several areas of social and adaptive functioning,
2and is associated with an elevated risk of peer conflicts and societal exclusion.
3,4 Therefore, evidence-based interventions aiming to enhance social skills in individuals with ASD are of pivotal importance.
Social skills group training (SSGT) is an umbrella term for interventions in the clinical management of ASD that apply socially instructive techniques and behavioral modification principles in a group setting. A recent systematic review including 19 randomized trials reported that SSGT is modestly effective.
5A new trial performed at six German
universities with specialized outpatient clinics was not included in the systematic review but suggests similar ef- fects.
6Most previous trials, however, have been conducted in controlled environments, with relatively small and selected samples and a restricted number of trainers.
7Furthermore, few females have been included in previous trials, and the moderating effects of basic characteristics such as gender and age are poorly understood. Thus, the generalizability and clinical relevance of the current body of evidence is limited.
The present pragmatic, multicenter trial sought to eval- uate the effectiveness of the SSGT “KONTAKT,”
8delivered by regular clinical staff, as a complement to standard care. KONTAKT has been piloted in Germany and Sweden and has indicated feasibility, social skills improvements, and general treatment satisfaction.
9,10A recent qualitative responder analysis demonstrated self- and parent-reported behavioral gains, even in participants who did not improve on standardized measures, with few or no negative effects.
11Participants in the present trial were representative of the heterogeneous group of children and adolescents with
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Supplemental material cited in this article is available online.
ASD admitted to regular mental health services, in whom neurodevelopmental and psychiatric comorbidity is commonplace.
12The primary study hypothesis was that SSGT as a complement to standard care would be superior to standard care only. A secondary aim was to explore the moderating effect of age and gender. This, to our knowl- edge, is the largest randomized trial of SSGT to date, and the first to evaluate effectiveness in a diverse sample of male and female children and adolescents in routine practice settings.
METHOD
Study Design
This was a 12-week multicenter, parallel-group, randomized, prag- matic clinical trial that included 296 youth aged 8 to 17 years with ASD. The trial was conducted at 12 child and adolescent psychiatry outpatient units and one academic clinical outpatient unit (Center of Neurodevelopmental Disorders at Karolinska Institutet [KIND]) in Stockholm and €Orebro counties, Sweden, between August 2012 and October 2015. Coordinating activities, data management, and anal- ysis were conducted at KIND. Table S1 (available online) provides detailed information. The study protocol13was approved by the ethics review board in Stockholm and the clinical authorities of the two involved counties.
Study Participants
Eligible participants were children (7–12 years) and adolescents (13–
17 years) with a clinical consensusInternational Classification of Dis- eases–10thRevision (ICD-10)14diagnosis of autism, atypical autism, Asperger syndrome, or pervasive developmental disorder not otherwise specified. The diagnosis was corroborated by ASD cut- offs (modules 3 or 4) met on the Autism Diagnostic Observation Schedule (ADOS),15which was conducted by examiners clinically trained in ADOS. All patients had Full Scale IQs> 70 according to the Wechsler Intelligence Scale for Children (third or fourth edi- tion)16,17and a common comorbid psychiatricICD-10 diagnosis of ADHD, anxiety disorder, or mood disorder, confirmed by the Kid- die Schedule of Affective Disorders and Schizophrenia.18Exclusion criteria included clinically assessed self-injury, anICD-10 diagnosis of conduct disorder, antisocial or borderline personality disorder, any psychotic disorder that would interfere with participation or require alternative treatment, and insufficient Swedish language capacities. The majority of participants (80%) were recruited by clinical referrals from the participating regular care units (Table S1, available online). Participants received an SEK 100 ($12) voucher as an incentive at the end of the study. Written informed consent was obtained from each participant and/or parent or legal guardian after the study’s aims and procedures had been fully explained.
Intervention
SSGT KONTAKT8(draft English version and other material avail- able upon request from the corresponding author) is a manualized, structured program for children and adolescents with ASD in the normative IQ range. It aims to improve social interaction and communication skills, social motivation, awareness of self and others, problem-solving capacities, and self-confidence. The pro- gram applies elements of cognitive-behavioral therapy (CBT), computer-based cognitive training, behavioral activation, psycho- education, observational learning, and parent involvement through various mandatory, recurring, and variable treatment formats (see
Tables S2 and S3, available online). Training sessions focus on un- derstanding social rules and relationships, initiating social over- tures, developing conversation skills, identifying and interpreting verbal and nonverbal social signals, managing conflicts, and developing social communication strategies. The teaching formats include individual goal identification, group discussions, social and role play, emotion-processing training, group activities, and tailored homework assignments aiming to facilitate generalization of skills to everyday life. Elements such as group discussions and role plays are applied more among the adolescents in the variable parts of the training, whereas more playful elements are used in the children’s group. Children are trained for 60 minutes and adolescents for 90 minutes per week in groups of 4 to 8 participants by 2 trainers. In this study, 12 sessions of increasing complexity were fully stan- dardized. The intervention was delivered by 50 clinicians (39 psy- chologists, 5 social workers, 3 nurses, 2 special educators, and 1 speech and language therapist) with an average clinical ASD experience of 6 years (range, 1–36 years). They were systematically trained on the program, including theory, supervision, and feed- back on recorded sessions (see Table S1, available online). After training, they were continuously supervised throughout the study to ensure the integrity of the SSGT. A checklist containing 11 items regarding protocol adherence and trainer skills in applying basic principles of the SSGT (e.g., positive reinforcement, modeling, prompting) was used to assess a random sample of 27 (25%) video- recorded sessions during monthly trainer meetings. Each item was scored“0” for no adherence, “1” for some adherence, and “2” for full adherence, and a mean score was derived across the items.
Treatmentfidelity was deemed adequate with a mean score of 1.65 (SD¼ 0.30).
Standard Care
Standard care included any ongoing support or intervention pro- vided by regular health care services (child psychiatry, pediatrics, habilitation centers, speech and language therapy). Information on the standard care for all participants was retrieved from their medical records and included pharmacological treatments, occupa- tional therapy, psychoeducation, general counseling, individual CBT, cognitive assistive technologies, and weighted blankets (Table 1).
Randomization and Blinding
The coordinating center randomly assigned eligible participants to SSGT or standard care using block randomization in a 1:1 ratio applying computer-generated random numbers (random.org) stratified within site and age group. Parents and trainers were aware of the treatment conditions. Teachers were blinded to treatment conditions; this was ensured by a teacher survey showing no awareness of SSGT participation beyond chance.
Outcome Measures
Change in total raw scores on the parent- and teacher-reported Social Responsiveness Scale (SRS)19 served as the primary outcome measure. The SRS is a 65-item Likert-type scale ques- tionnaire to assess social communication and autistic traits, with scores ranging between 0 and 195 (higher values indicate greater severity) that has demonstrated sensitivity to behavior change in several SSGT studies as well as excellent psychometric properties.19-21 Secondary outcome measures were parent and blinded teacher ratings on the Adaptive Behavior Assessment SystemII (ABAS-II),22 the trainer-rated Developmental Disabilities modification of the Children’s Global Assessment Scale (DD-CGAS),23,24 Ohio State University (OSU) Global Severity Scale for Autism (OSU Autism
CGI-S),24,25parental self-ratings on the Perceived Stress Scale (PSS),26 and children’s/adolescents’ self-ratings on the Children in Stress (CiS) scale.27 All measures were taken at baseline, at 12 weeks (posttreatment), and 3 months after the end of the training (follow- up). For a more detailed description of the outcome measures, see Table S1, available online.
Adverse Effects
Parent-reported adverse events were collected at posttreatment and at follow-up using a treatment satisfaction questionnaire that inquired about drawbacks of the training and psychological, social, or other adverse effects considered to be related to the treatment (Table S1, available online). In addition, qualitative individual in- terviews were conducted in a subsample of children, adolescents, and their parents.11
Statistical Analyses
Sample size calculation to test superiority of SSGT compared to standard care alone was based on medium effect sizes found in previous pilot studies of KONTAKT.9,10A sample size of 144 par- ticipants per group was required to provide 80% power (1
b
) at a two-sided 5%a
level and 5% attrition. Analyses were performed for the total sample and stratified by age group (children and adoles- cents) and gender (males and females). Primary and secondary an- alyses were conducted according to intention-to-treat principles including all randomized participants for whom data were available at baseline. Mixed-effect linear modeling (random regression), which uses all available data in longitudinal study designs and can handle missing data, was used to provide unbiased treatment ef- fects. The model was specified by using time (baseline, posttreat- ment, follow-up), treatment group (SSGT þ standard care vs.standard care), and the time by group interaction asfixed effects, with a random intercept for each participant. The results were pre- sented as least-squares means from the mixed-effect models. The treatment effect was expressed as the group difference in the change of least-squares mean scores from pretreatment to posttreatment/
follow-up. The slope of the regression line was compared between treatment groups. Moderator analyses for age group and gender were conducted by including the three-way interaction of time by group by moderator, all main effects, and all lower-order in- teractions terms in the model. Effect sizes were estimated by dividing the group difference in the change of least-squares mean scores from pretreatment to posttreatment/follow-up by the pooled standard deviation at pretreatment. Throughout the article, positive effect sizes favor SSGT. The analyses were conducted using R soft- ware version 3.2 and IBM SPSS statistics version 24.
RESULTS
A total of 366 children and adolescents were assessed for eligibility (Figure 1). Of these, 296 (208 boys, 88 girls) met the inclusion criteria. Participants were randomly assigned to 12-week SSGT (n ¼ 150; children, 83; adolescents, 67) or standard care alone (n ¼ 146; children, 89; adolescents, 57).
There was a larger proportion of females among the ado- lescents (36.3%) than among the children (25.0%). The number enrolled varied across sites (11–39 participants). The study groups were similar at baseline for major de- mographic and clinical characteristics, with the exception that the standard care group received significantly more individual CBT and counseling (Table 1).
Primary Outcome Measures
Parent-rated SRS total scores decreased for both treatment groups from baseline to posttreatment (SSGT: 87.9 to 78.7;
standard care: 87.9 to 81.8; treatment effect, 3.1; 95%
CI ¼ 7.2 to 0.9, p ¼ .13, effect size [ES] ¼ 0.13) and follow- up (SSGT: 87.9 to 77.3; standard care: 87.9 to 81.8; treatment effect, 3.8; 95% CI ¼ 8.1 to 0.4; p ¼ .08; ES ¼ 0.16), but no TABLE 1 Demographic and Clinical Characteristics at
Baseline by Treatment Group
Variable
SSGTþ Standard Care
(n¼ 150)
Standard Care (n¼ 146)
p
Mean SD Mean SD
Age (y) 12.05 2.61 11.59 2.66 .13
WISC, Full Scale IQ 96.95 13.45 98.13 12.91 .44 ADOS, social
communication total
10.65 3.53 11.03 3.69 .36
Parental age (y) 45.53 5.33 46.40 5.81 .18 Parental education (y) 14.37 2.92 14.51 3.04 .70
n % n %
Males 107 71 101 69 .78
Ethnicity
Swedish 136 91 134 92
Other Scandinavian 3 2 0 0 .22
Other 11 7 12 8
ASD diagnosis
Autism 15 10 10 7
Asperger disorder 90 60 91 62 .62
PDD-NOS 45 30 45 31
Comorbidity
ADHD 115 77 113 77 .99
Anxiety disorder 28 19 33 23 .49
Depression 18 12 18 12 .99
Othera 22 15 23 16 .92
2 Mental/behavioral disorders
11 7 18 12 .21
Pharmacological treatment
Central stimulants 79 53 74 51 .82
Sleep inducing 27 18 39 27 .10
SSRIs 23 15 24 16 .92
2 Psychotropics 42 28 43 29 .88
Individual psychological treatment
CBT 1 1 9 6 .02
General counseling 3 2 18 12 .001
Habilitation services Parental
psychoeducation
34 23 42 29 .29
Otherb 3 2 9 6 .13
Note: ADHD ¼ attention-deficit/hyperactivity disorder; ADOS ¼ Autism Diagnostic Observation Schedule; ASD¼ autism spectrum disorder; CBT ¼ cognitive-behavioral therapy; PDD-NOS¼ pervasive developmental disor- der not otherwise specified; SSGT¼ social skills group training; SSRI ¼ selective serotonin reuptake inhibitor; WISC¼ Wechsler Intelligence Scale for Children.
ae.g., Tourette’s disorder, obsessive-compulsive disorder.
be.g., Heavy weighted blankets and cognitive support.
significant group difference was found (Table 2, Table S4, available online, Figure 2A).
Although no significant group difference was observed for children (Table S5, available online, Figure 2B), adoles- cents showed a significantly larger change in parent-rated SRS for SSGT compared with standard care alone both posttreatment (8.3; 95% CI ¼ 14.7 to 1.9; p ¼ .012, ES ¼ 0.32) and at follow-up (8.6; 95% CI ¼ 15.4 to 1.8; p ¼ .015, ES ¼ 0.33) (Table S5, available online, Figure 2C). These effects were driven mostly by scores decreasing from higher symptomatology levels in the SSGT group at baseline among adolescents. The three-way interaction term (time by treat- ment group by age group) reached statistical significance from baseline to posttreatment (p ¼ .04) but not from base- line to follow-up (p ¼ .08).
Females receiving SSGT had a significantly larger change in parent-rated SRS than females receiving standard care alone posttreatment (8.9; 95% CI ¼ 16.2 to 1.6; p ¼ .019,
ES ¼ 0.40) but not at follow-up (5.9; 95% CI ¼ 13.7 to 1.0;
p ¼ .14, ES ¼ 0.26) (Table S6, available online, Figure 2D). No significant group difference was observed for males (Table S6, available online, Figure 2E). The three-way inter- action term (time by treatment group by gender) did not reach statistical significance from baseline to posttreatment (p ¼ .08) or from baseline to follow-up (p ¼ .56). Sensitivity analyses with the sample split into four cells (male children, female children, adolescent males, and adolescent females) indicated no meaningful effect for children regardless of gender. There was a positive treatment effect for female adolescents in particular, which was partly attributable to less improvement in the standard care group (Table S7, available online).
Teacher-rated SRS did not suggest any significant treat- ment gains at posttreatment or follow-up (Table 2, Table S4, available online). The teacher-rated outcomes should be interpreted with caution, however, because of unsatisfactory FIGURE 1 Consolidated Standards for Reporting Trials (CONSORT) flow diagram. Note: ADOS ¼ Autism Diagnostic
Observation Schedule; ASD ¼ autism spectrum disorder; SRS ¼ Social Responsiveness Scale; SSGT ¼ social skills group training;
WISC ¼ Wechsler Intelligence Scale for Children.
Assessed for eligibility (n=366)
Excluded (n=70)
28 ADOS score below cut-off 12 ADOS data missing
9 ADOS + WISC data missing 8 Parent SRS baseline missing 7 WISC data missing 4 IQ<70
2 Did not have complex ASD
Allocated to SSGT KONTAKT (n=150)
12 weeks/posttreatment:
Assessed (n=129) Dropped out (n=7) Missing data (n=10)
Allocated to Standard Care (n=146)
3-month follow-up:
Assessed (n=106) Dropped out (n=7) Missing data (n=33) 3-month follow-up:
Assessed (n=107) Dropped out (n=22) Missing data (n=21) 12 weeks/posttreatment:
Assessed (n=117) Dropped out (n=22) Missing data (n=11)
Included in the primary analysis according to intention to treat principle (n=150)
Included in the primary analysis according to intention to treat principle (n=146)
Randomized (N=296)
rates of complete data (see below). There was no effect of site on the primary outcome measures, indicating similar effects of SSGT training across participating centers.
Secondary Outcome Measures
SSGT was superior to standard care alone on secondary parent-rated outcomes of adaptive behavior on the ABAS-II (10.7; 95% CI ¼ 1.5 to 19.8; p ¼ .02, ES ¼ 0.36) and parental stress reductions on the PSS (3.6; 95% CI ¼ 5.6 to 1.5;
p < .001, ES ¼ 0.50) at follow-up (Table 2, Table S8, available online). Moreover, trainer ratings indicated significantly greater improvement from baseline to follow-up in the SSGT group in global functioning on the DD-GAS (3.2; 95% CI ¼ 1.5 to 4.9; p < .001, ES ¼ 0.45) and clinical severity on the OSU Autism CGI-S (0.3; 95% CI ¼ 0.5 to 0.1; p ¼ .002, ES ¼ 0.38) (Table 2). There were no significant effects of SSGT on teacher-rated increase in adaptive behavior on the ABAS-II or participant-reported decrease of stress compared to standard care (Table 2). The overall pattern of results for secondary outcomes did not indicate substantial gender and age differences, and there were significant effects on several secondary outcomes regardless of age group and gender (Tables S5 and S6, available online).
Adverse Events
Parent-reported information was available for 143 of the 150 participants in the SSGT group posttreatment. Missed time in school due to training was reported by 19 (13.3%), increased stress by 6 (4.2%), increased behavioral problems by 1 (0.7%), decreased attention by 1 (0.7%), increased anxiety by 1 (0.7%), and increased fatigue by 1 (0.7%). In- formation was available from 118 parents at follow-up.
Missed time in school was reported by 6 (5.1%), and increased stress by 1 (0.8%). Previously published inter- view data on a subsample of 11 participants and their parents revealed 1 adverse event in the SSGT group (increasing severity of social anxiety) and none in the controls.
11Attrition and Missing Data
A total of 22 participants (15%) in the SSGT arm did not complete the training, and 7 (5%) dropped out from stan- dard care (Figure 1). There were no statistically significant differences between completers and noncompleters regarding clinical and demographic characteristics. Parent- rated data were incomplete for a total of 33 participants (22%) posttreatment and 43 participants (29%) at follow-up for SSGT, as well as 17 participants (12%) posttreatment and 40 participants (27%) at follow-up for standard care.
Missing data were associated with lower IQ and higher parent-rated SRS at baseline, a pattern that was nearly identical for both groups. Trainer ratings were incomplete for 29 participants (19%) posttreatment and 41 participants (27%) at follow-up for SSGT, as well as 12 participants (8%) posttreatment and 28 participants (19%) at follow-up for standard care. Teacher ratings were incomplete for 77 par- ticipants (51%) posttreatment and 92 participants (61%) at follow-up for SSGT, as well as 63 participants (43%) post- treatment and 87 participants (60%) at follow-up for stan- dard care.
DISCUSSION
SSGT is presumably the most frequently used intervention for individuals with ASD without intellectual disability. This TABLE 2 Primary and Secondary Outcome Measures, Week 12/Posttreatment, and 3-Month Follow-Up
Measure (Rater) Assessment Point
Group Differencea
p Effect Size
Change Scores 95% CI
SRS (parent) Posttreatment e3.1 e7.2 to 0.9 .13 0.13
Follow-up e3.8 e8.1 to 0.4 .08 0.16
SRS (teacher) Posttreatment 5.8 e1.3 to 12.9 .11 e0.22
Follow-up 5.3 e2.4 to 13.1 .18 e0.21
ABAS-II (parent) Posttreatment 11.9 3.3 to 20.6 .01 0.40
Follow-up 10.7 1.5 to 19.8 .02 0.36
ABAS-II (teacher) Posttreatment e0.9 e13.3 to 11.6 .89 e0.02
Follow-up e0.7 e14.4 to 13.0 .92 e0.01
DD-CGAS (trainer) Posttreatment 2.4 0.8 to 4.1 .004 0.34
Follow-up 3.2 1.5 to 4.9 <.001 0.45
CGI-S (trainer) Posttreatment e0.3 e0.5 to e0.1 <.001 0.41
Follow-up e0.3 e0.5 to e0.1 .002 0.38
CiS (child self-report) Posttreatment 0.0 e0.1 to 0.1 .76 e0.03
Follow-up 0.0 e0.1 to 0.1 .97 0.00
PSS (parental self-report) Posttreatment e1.6 e3.6 to 0.4 .11 0.22
Follow-up e3.6 e5.6 to e1.5 <.001 0.50
Note: ABAS-II¼ Adaptive Behavior Assessment System II; CGI-S ¼ Ohio State University (OSU) Autism Clinical Global ImpressioneSeverity; CiS ¼ Children in Stress;
DD-CGAS¼ Developmental Disabilities modification of the Children’s Global Assessment Scale; PSS ¼ Perceived Stress Scale; SRS ¼ Social Responsiveness Scale.
aData are presented as least-squares means with 95% CI.
study is the largest randomized trial of SSGT to date, and the first to evaluate its effectiveness in routine care. We demonstrate a small to moderate added value of SSGT in terms of improvements on ratings of autism-related symp- tomatology and adaptive functioning compared to standard care, although the effect on the primary outcome was limited to adolescents and females and was observed only by un- blinded parents. The intervention was well tolerated, and 85% of the participants completed the training. Missing school due to training was the only frequently reported negative effect. Our overall pattern of findings is consistent with those of previous trials.
5,6To maximize generalizability of the results and to demonstrate applicability in clinical practice, this prag- matic trial aimed for heterogeneity in several aspects. No fewer than 50 clinicians from 13 regular care units were involved in delivering the intervention. The study popu- lation comprised children and adolescents with ASD who were typically admitted to mental health services. A substantial proportion were female. Heterogeneity can, on the other hand, lead to dilution of the treatment effects, which may partially account for the mixed results of this study. The analyses indicated that the effects were moderated by age, and possibly also by gender. A potentially more favorable outcome for adolescents than for children might have several explanations. First, the intensity of training is 30 minutes longer per session for adolescents than for children. The decision to restrict the children’s sessions to 60 minutes was based on clinical experience, and reflects how the training is delivered in clinical practice. Ninety-minute training sessions have not been found useful for children, as their attention span, motivation, and cooperativeness tend to decline after 1 hour. Still, the large difference in dose precludes direct comparison between children and adolescents. Second, we estimate that homework might have been more beneficial and consistently applied by older participants.
Adolescents with ASD encounter higher social expecta- tions and demands than do children,
28and thus might be more motivated to improve their social skills. Children, on the other hand, needed more support to complete their assignments. Third, neural maturation and the develop- ment of associated cognitive functions
29required to ac- quire social skills might not always be sufficiently developed in children. The gender-specific results, sug- gesting that the intervention possibly is more effective for females than for males, are novel and ground breaking.
Previous trials have included too few females to address this issue properly. The previous, largest published trial, including only 15 females in total, found that the female subsample descriptively showed a stronger improvement than the male subsample.
6Although research on gender differences in ASD is an emerging field,
30we are among the first to report gender differences regarding treatment response.
In terms of recommendations, the results from the moderator analyses should not be overstated. The rela- tively modest effects found in the present and previous FIGURE 2 Means and 95% CIs for parent-rated Social
Responsiveness Scale (SRS) scores for the total group and separately by age group and gender.
Parent−Rated SRS Total ScoreParent−Rated SRS Total ScoreParent−Rated SRS Total ScoreParent−Rated SRS Total ScoreParent−Rated SRS Total Score
A
100 95 90 85 80 75
Total Sample
Standard Care KONTAKT
70 p = .13 p = .08
65 60 55 50
Baseline Posttreatment 3-month follow-up Time Point
B
100 95 90 85 80 75 70 65 60 55 50
Children
p = .81 p = .88
Baseline Posttreatment 3-month follow-up Time Point
C
100 95 90 85 80 75 70 65 60 55 50
Adolescents
p = .012 p = .015
Baseline Posttreatment 3-month follow-up Time Point
D
100 95 90 85 80 75 70 65 60 55 50
Girls
p = .019 p = .26
Baseline Posttreatment 3-month follow-up Time Point
E
100 95 90 85 80 75 70 65 60 55 50
Boys
p = .77 p = .26
Baseline Posttreatment 3-month follow-up Time Point
trials
5,6rather point to a need for improved SSGT tech- niques for all participants. Increased quality of feedback, additional strategies to maintain focused practice and motivation, making the content more developmentally appropriate, and sustained training appear as potential areas of further improvement. Indeed, extended training beyond 12 weeks might be one of the most logical and promising areas to explore. Most SSGT programs evalu- ated to date have lasted no more than 3 to 4 months, which is far less than the time devoted to many other in- terventions for individuals with ASD (e.g., early intensive behavioral intervention implying many hours of training per week over years). Notably, a wish for continued training after completion of the program has been expressed by participants and their parents.
11Some study limitations should be noted. First, the validity of the teacher ratings was undermined by an unsatisfactory response rate. As a consequence, our conclusions are based on unblinded ratings. Although we cannot rule out the possibility that the estimated effects to some extent reflect bias, the inconsistent results across measures and subgroups are not readily explained by bias. Still, development of practical and valid observational measures for blinded ob- servers is of great importance for the future progress of research in this field. Due to our discouraging experience with teacher ratings, we would suggest alternative routes such as blinded ratings of video recordings. Overall, more sensitive and relevant outcome measures are needed. In particular, an increased focus on long-term functional outcome and quality of life would provide a valuable basis for clinical decisions and health economic analyses. Second, without an active control group, we cannot rule out that simply joining a group of peers with similar difficulties might account for the observed gains. However, in accor- dance with the principles of pragmatic trials, the paramount objective was to determine whether SSGT added value to standard care. Moreover, a previous qualitative responder analysis indicated that improvements are likely to be asso- ciated with certain elements of the program, rather than merely the group setting.
11Third, the large number of ana- lyses increases the risk of type I errors. In interpreting our findings, it therefore seems appropriate to focus more on the overall pattern of results than on any specific result. Finally, other potential sources of bias were the somewhat higher rate of missing data in the intervention group, and that the standard care group received more individual CBT and counseling, which might have led to an underestimation of the true effect of SSGT.
We conclude that for adolescents, especially females, a 12-week SSGT was superior to standard care alone, with small to moderate positive effects on social responsiveness, general clinical severity, and adaptive functioning. For children, on the other hand, significant gains were observed on secondary outcomes only. The applicability in clinical practice was demonstrated by the routine clinical settings, the regular staff delivering the intervention, and the inclusion of clients typically referred to child and adolescent psychiatry. Given the lack of other proven treatment options, SSGT could be a valuable complement
to standard care. However, further efforts to improve the training are needed to move beyond the current standard.
Awaiting more research on how the training should be optimized for different subgroups, clinicians are advised to adhere to the manual but may continue training with an increasing degree of tailoring after completion of the 12- week program. &
Accepted May 3, 2017.
Drs. Choque Olsson, Jonsson, Tammimies, B€olte, Mssrs. Flygare, G€orling, Berggren, and Mss. Coco and Råde are with Center of Neurodevelopmental Disorders (KIND), Neuropsychiatry Unit, Karolinska Institutet, Stockholm, and Child and Adolescent Psychiatry, Center for Psychiatry Research, Stockholm County Council, Stockholm. Dr. Serlachius is also with Child and Adolescent Psychiatry, Center for Psychiatry Research. Dr. Chen is with Karolinska Insti- tutet. Dr. Kjellin and Ms. Lindstedt are with University Health Care Research Center, Faculty of Medicine and Health, €Orebro University, €Orebro, Sweden.
The study was funded by the Stockholm County Council, Karolinska Institutet, the Swedish Research Council, the Foundation Sunnerdahls Disability, Maj- blomman. The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Parts of this work and preliminary results were presented orally at the Meeting of the Scientific Society Autism Spectrum in Freiburg, Germany, March 11, 2016; at the International Meeting for Autism Research, Baltimore, MD, May 12, 2016; and at the American Academy of Child and Adolescent Psy- chiatry’s 63rd Annual Meeting, New York, NY, October 26, 2016.
Dr. Chen served as the statistical expert for this research.
The authors thank the children, adolescents, parents, and teachers who participated in the study, Anneli Sj€oberg, MSc, of Child and Adolescent Psychiatry Stockholm County Council, for supporting treatment satisfaction data compilation, and Lynnea Myers, MSc, of Center of Neurodevelopmental Disorders (KIND), Department of Women’s and Children’s Health, Karolinska Institutet, for language review. The authors are also thankful to the leads of child and adolescent psychiatry (Olav Bengtsson, MD, Paula Liljeberg, MD, Charlotta Wiberg Spangenberg, MSc, Peter Ericson, MSc, Karin Forler, MSc, Alkisti Nikolayidis Linderholm, MSc, all of Stockholm County Council), PRIMA J€arva child and adolescent psychiatry (MaiBritt Giacobini, MD, PhD, of Kar- olinska Institutet), and child and adolescent habilitation services (Moa Pellrud, MSc, of €Orebro County Council) for organizational support. Finally, the au- thors direct sincere thanks to the administrative personnel and the clinicians at the child and adolescent psychiatry Stockholm outpatient units (BUP Bromma, BUP Danderyd, BUP Jakobsberg, BUP KIND, BUP MV Nordost, BUP MV Sydv€ast, BUP Sollentuna, BUP Solna, BUP Sk€arholmen, BUP S€odert€alje, BUP T€aby), PRIMA J€arva child and adolescent psychiatry unit, and the child and adolescent habilitation services.
Disclosure: Dr. Choque Olsson has received grants and personal fees from Foundation Sunnerdahls Disability, Majblomman, Stockholm County Council, and the Pediatric Research Foundation at Astrid Lindgren Children’s Hospital.
Dr. Serlachius has received grants from the Swedish Research Council for Health, Working Life and Welfare, the Stockholm County Council and Jane and Dan Olsson foundation. Dr. Jonsson has received grants from the Swedish Research Council and the Swedish Social Insurance Agency. Dr. Tammimies has received grants from Swedish Research Council, the Stockholm County Council, the Swedish Foundation for Strategic Research, Jeansson Founda- tions, Ake Wiberg Foundation, the Swedish Foundation for International Cooperation in Research and Higher Education, and the Swedish Brain Foundation. She has also received the L’Oreal-UNESCO for Women in Sci- ence prize in Sweden. Dr. Kjellin has received grants from the Swedish Research Council for Health, Working life and Welfare and the Swedish National Board of Institutional Care. Dr. B€olte has received grants from the Swedish Research Council, the Stockholm County Council, the Autism and Asperger Society Stockholm, Hj€arnfonden, Vinnova, Swedish Research Council for Health Working Life and Welfare (FORTE), FORMAS, The Free- mans Grand Lodge of Sweden, S€allskapet Barnavård, Swedish Board of Health and Welfare, Pediatric Research Foundation at Astrid Lindgren Chil- dren’s Hospital, Swedish Association of Local Authorities and Regions, Trygg Hansa, F€ors€akringskassan, Stiftelsen Markus och Amalia Wallenbergs Min- nesfond, Stiftelsen Sunnerdahls Handikappfond, European Union (FP7,
H2020), Niclas €Oberg Foundation Life Watch, Tore Nilsson Stiftelse, Stiftelse Kempe-Carlgrenska Fonden. During the conduct of the study, he received personal fees from Shire, Roche, Eli Lilly and Co., GLGroup, System Analytic, Kompetento, Expo Medica, ProPhase, Kohlhammer, UTB, and Huber/Hog- refe. He is an author of the German and Swedish KONTAKT manuals and receives royalties. Mr. Flygare has received grants from the Stockholm County Council. Mr. Berggren has received grants from the Stockholm County Council and personal fees from Kompetento, Expo Medica, and Pysslingen group.
Dr. Chen, Mrs. Coco, Mr. G€orling, Mrs. Råde, and Mrs. Lindstedt report no biomedicalfinancial interests or potential conflicts of interest.
Correspondence to Sven B€olte, PhD, Center of Neurodevelopmental Disorders (KIND), Child and Adolescent Psychiatry Research Center, Karolinska Institutet and Stockholm County Council, G€avlegatan 22B, S-11330 Stockholm, Sweden; e-mail: sven.bolte@ki.se
0890-8567/$36.00/ª2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/
4.0/).
http://dx.doi.org/10.1016/j.jaac.2017.05.001
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