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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an after-school program can help children with high-functioning autism improve their social skills. The program, known as a Social Intervention, includes fun activities and social skills groups led by trained staff, conducted four times a week for eight weeks. Children with autism who do not have an intellectual disability might find this trial suitable. Participants will either join the program immediately or wait and join later, allowing researchers to compare results. The trial will assess how the program influences social skills and behaviors at home and during games. As an unphased trial, this study provides a unique opportunity for children to enhance their social skills through engaging activities.

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 prior data suggests that this social intervention is safe for children with hfASD?

Research has shown that social skills training (SST) can enhance social skills, communication, and behavior in children with autism spectrum disorder (ASD). Studies have found these programs to be safe and well-tolerated, with no major negative effects reported.

A review of 19 studies found that SST is somewhat effective, suggesting it can be a useful and safe method for children with ASD. Since this training includes activities like social groups and games, it doesn't involve medical procedures or drugs, making it generally safe for children.

Overall, previous research indicates that social interventions hold promise in safely helping children with ASD improve their social skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the after-school social intervention for autism because it offers a unique hands-on approach that integrates social skills training directly into a child's daily routine. Unlike traditional therapies that might take place in a clinical setting, this intervention happens in a familiar environment, potentially making it more engaging and less intimidating for children with high-functioning autism spectrum disorder (hfASD). By delivering four 90-minute sessions per week over eight weeks, the program emphasizes consistency and practice, which are crucial for developing social skills. This method could lead to more meaningful and lasting improvements in social interactions compared to existing therapies.

What evidence suggests that this social intervention is effective for children with hfASD?

Research has shown that social skills training (SST) can enhance social skills, communication, and behavior in children with autism spectrum disorder (ASD). Studies have found that these programs boost social understanding and reduce ASD-related challenges, particularly in children with autism who do not have intellectual disabilities. The training aims to teach and strengthen social behaviors, helping children interact better with others. By focusing on social skills, SST can significantly improve everyday interactions for children with ASD. In this trial, some participants will receive an after-school social intervention led by trained paraprofessional staff, while others will be in a no-treatment control group. These findings suggest that after-school social programs led by trained assistants can be effective. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11918677/

Effectiveness of social skills training interventions for ... A number of previous studies have shown that SST can be effective in improving social skills, communication skills, and behavioral issues in children with ASD.

2. tp.amegroups.org tp.amegroups.org/article/view/143663/html

Social skills interventions for children and adolescents with ... It aims at enhancing social-cognitive abilities, social-communication skills, and reducing ASD-related symptoms in children with HFASD (29).

3. nature.com nature.com/articles/s41598-024-83953-9

The effectiveness of social training in individuals with ... This study systematically explores the transferability of social training in individuals with ASD, guided by the conceptual model known as the FIELD framework.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211609522000070

Measurement of social skills treatment outcome in autism The current paper serves as a scoping review of outcome measurement in SSI research in autistic populations.

5. autisminternetmodules.org autisminternetmodules.org/m/529

Overview of Social Skills and Intervention Strategies The purpose of this module is to provide an overview of the common social skill difficulties exhibited by individuals on the autism spectrum.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7670840/

Social Skills Training for Autism Spectrum Disorder: a Meta ... The present meta-analysis reviews recent evidence and compares the efficacy of 14 F2F-SST and four identified BITs-SST intervention trials for youth with ASD.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05341011

Establishment of Social Skills Training Group in ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0890856717302022

Social Skills Training for Children and Adolescents With ... A recent systematic review including 19 randomized trials reported that SSGT is modestly effective.