After-School Social Intervention for Autism

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Canisius College

Disqualifiers: Psychosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 34

Duration: 8 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

Social skills interventions are sometimes used to treat the social impairments of higher-functioning children with autism spectrum disorder (hfASD; without intellectual disability). Despite the recognized need for such treatments, few children with hfASD receive social interventions. Efforts to develop and implement school social interventions have been hindered by barriers during the school day (e.g., lack of resources, staffing, training, and time). As such, there is a need for feasible and effective social interventions that can be delivered by non-professional (paraprofessional) school staff in school settings including after-school programs. The purpose of this study is to test the feasibility and initial efficacy of an after-school social intervention delivered by paraprofessionals in school settings for children with hfASD. Children will be randomly assigned to the social intervention group or a no-treatment control (waitlist) group. The intervention will be delivered by paraprofessionals four days per week (90 minutes per session) over eight weeks during the children's after-school program conducted at their schools. Sessions include social skills groups, social recreational games to practice skills, and behavioral reinforcement to strengthen learning. Feasibility will be assessed via implementation fidelity (accuracy), parent and child satisfaction ratings, and attendance and attrition rates. Outcomes will test the intervention effect on a child test of social-cognition, parent ratings of social skills and ASD symptoms, and behavioral coding of social competence by naïve raters during unstructured game play. Child outcome measures will be completed for both the social intervention group and no-treatment control (waitlist) group immediately prior to (pretest) and following (posttest) the eight-week intervention, and children initially assigned to the social intervention will also complete the assessments three months later (follow-up). Children assigned to the no-treatment control (waitlist) group will receive the social intervention after the intervention group completes the social intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on social interventions rather than medication changes.

What data supports the effectiveness of the treatment Social Intervention, Social Skills Training, Social Skills Intervention, Paraprofessional-Delivered Social Intervention for autism?

Research shows that social interventions, including those delivered by trained paraprofessionals, can improve social skills in children with autism. Studies have demonstrated that children with autism who participated in social skills programs, such as those in inclusive summer camps or with peer-implemented training, showed increased social engagement and achieved their social goals. ^{1 2 3 4 5}

Is the After-School Social Intervention for Autism safe for humans?

The research on social skills training for autism, which includes various methods like social stories and video modeling, does not report any significant safety concerns, suggesting it is generally safe for humans. ^{5 6 7 8 9}

How is the Social Intervention treatment for autism different from other treatments?

This treatment is unique because it involves training paraprofessionals (support staff) to deliver social skills training during unstructured times like after-school, which helps children with autism improve their social interactions with peers. Unlike other treatments, it focuses on real-world social settings and uses school personnel to implement the intervention, making it more accessible and practical. ^{1 2 6 7 10}

Eligibility Criteria

This trial is for higher-functioning children with autism spectrum disorder (hfASD) who have no intellectual disability. They must have a prior clinical diagnosis of ASD, confirmed by specific assessments and an IQ score over 70. Children with evidence of psychosis are not eligible.

Inclusion Criteria

Diagnostic confirmation via the Autism Diagnostic Interview-Revised

I have been diagnosed with Autism Spectrum Disorder.

Wechsler Abbreviated Scale of Intelligence-2nd Edition IQ score >70

Exclusion Criteria

Evidence of psychosis per parent report and prior psychiatric evaluation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Training

Paraprofessionals complete a 20-hour training to implement the intervention

1 week

Treatment

Social intervention delivered by paraprofessionals four days per week for 90 minutes per session over eight weeks

8 weeks

32 sessions (in-person)

Follow-up

Participants are monitored for maintenance of intervention effects three months after the social intervention

12 weeks

1 visit (in-person)

Treatment Details

Interventions

• Social Intervention

Trial Overview The study tests an after-school social intervention delivered by paraprofessionals to improve social skills in children with hfASD. It involves group sessions and games four days a week for eight weeks, comparing the effects against a waitlist control group.

Participant Groups

Group I: Social intervention Experimental Treatment 1 Intervention

The social intervention consists of four 90-minute sessions per week delivered over eight weeks by paraprofessional staff to children with hfASD as part of their existing after-school program.

Group II: No-treatment control Active Control 1 Intervention

Children in the no-treatment control condition will receive no after-school social programming during the active social intervention study phase.

Who Is Running the Clinical Trial?

Canisius College

Lead Sponsor

Trials

2

Recruited

150+

Findings from Research

A 2-week inclusive summer camp program effectively helped four children with autism spectrum disorder achieve their individualized education program (IEP) social goals, demonstrating significant social improvements that were maintained after the program.

The study highlights the feasibility of using trained paraprofessionals to implement social interventions in inclusive settings, suggesting that such programs can be beneficial for enhancing social skills in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting IEP Social Goals for Children with Autism in an Inclusive Summer Camp. Koegel, LK., Glugatch, LB., Koegel, RL., et al.[2021]

Training paraprofessionals to implement social interventions during unstructured social periods, like lunch-recess, can significantly enhance social engagement for students with Autism Spectrum Disorder (ASD) with their typical peers.

After receiving brief training, paraprofessionals successfully increased social opportunities, leading to higher levels of engagement and initiation of interactions among children with ASD in a group setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training paraprofessionals to improve socialization in students with ASD. Koegel, RL., Kim, S., Koegel, LK.[2021]

The study involved two children with autism and eight typical peers, who were trained in pivotal response training (PRT) strategies to improve social skills.

After the intervention, children with autism showed increased levels of social behavior, suggesting that peer-implemented PRT can be an effective method for enhancing social skills in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple peer use of pivotal response training to increase social behaviors of classmates with autism: results from trained and untrained peers. Pierce, K., Schreibman, L.[2019]

A synthesis of 66 studies involving 513 participants indicates that various interventions can effectively enhance social behavior in individuals with autism, highlighting the importance of tailored approaches based on age and delivery method.

Social skills groups have been classified as an established evidence-based practice (EBP), while video modeling is recognized as a promising EBP, suggesting these methods are particularly effective in addressing social deficits in autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social skills interventions for individuals with autism: evaluation for evidence-based practices within a best evidence synthesis framework. Reichow, B., Volkmar, FR.[2021]

This study aims to systematically review the effectiveness and safety of social skills interventions (SSI) for children with autism spectrum disorder (ASD) by analyzing randomized controlled trials from multiple databases.

The findings will help provide evidence-based insights for clinicians and patients regarding the management of ASD through SSI, potentially improving treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of social skills intervention for the management of children with autism spectrum disorder: A protocol for systematic review and meta-analysis. Shuai, FR., Lin, ZY.[2023]

Social skills training programs can effectively improve social competence in individuals with autism spectrum disorder, but the improvements are not always consistent across different outcomes.

Most research has focused on school-aged children with autism who have average or above-average intellectual functioning, limiting the generalizability of these programs to a broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Skills Training in Autism Spectrum Disorder Across the Lifespan. Moody, CT., Laugeson, EA.[2021]

Social skills training programs can effectively improve social competence in individuals with autism spectrum disorder, but the improvements may not be consistent across all measured outcomes.

Most research has focused on school-aged children with autism who have average or above-average intellectual functioning, indicating a need for broader studies that include diverse age groups and intellectual abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Skills Training in Autism Spectrum Disorder Across the Lifespan. Moody, CT., Laugeson, EA.[2021]

Social skills training (SST) is essential for youth with autism spectrum disorders (ASD) due to their common social skill deficits, and various effective strategies exist, such as social stories and video modeling.

Assessment of social skills is a critical first step in implementing SST, and research supports the use of specific assessment measures to enhance the effectiveness of these training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social skills training for youth with autism spectrum disorders. Bellini, S., Peters, JK.[2008]

A randomized controlled trial involving 120 children with autism spectrum disorders (ASDs) is evaluating the effectiveness of social skills training (SST) with and without parent and teacher involvement, aiming to improve socialization and generalization of skills to daily life.

The study will assess outcomes before, immediately after, and 6 months post-intervention, providing insights into the long-term efficacy of SST and the potential benefits of involving parents and teachers in the training process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled study of a social skills training for preadolescent children with autism spectrum disorders: generalization of skills by training parents and teachers? Dekker, V., Nauta, MH., Mulder, EJ., et al.[2021]

Training paraprofessionals to implement various interventions for individuals with autism spectrum disorders (ASD) showed positive outcomes in 92% of the 12 studies reviewed, involving a total of 39 participants.

The interventions included methods like social stories and the Picture Exchange Communication System (PECS), with training methods such as role playing and video demonstrations, indicating effective strategies for supporting individuals with ASD in school and rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training paraprofessionals to implement interventions for people autism spectrum disorders: a systematic review. Rispoli, M., Neely, L., Lang, R., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Targeting IEP Social Goals for Children with Autism in an Inclusive Summer Camp. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Training paraprofessionals to improve socialization in students with ASD. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Multiple peer use of pivotal response training to increase social behaviors of classmates with autism: results from trained and untrained peers. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Social skills interventions for individuals with autism: evaluation for evidence-based practices within a best evidence synthesis framework. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of social skills intervention for the management of children with autism spectrum disorder: A protocol for systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Social Skills Training in Autism Spectrum Disorder Across the Lifespan. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Social Skills Training in Autism Spectrum Disorder Across the Lifespan. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Social skills training for youth with autism spectrum disorders. [2008]

9. England pubmed.ncbi.nlm.nih.gov

A randomized controlled study of a social skills training for preadolescent children with autism spectrum disorders: generalization of skills by training parents and teachers? [2021]

10. England pubmed.ncbi.nlm.nih.gov

Training paraprofessionals to implement interventions for people autism spectrum disorders: a systematic review. [2018]