Social and Communication Intervention for Autism

Recruiting at 2 trial locations

Overseen By Rebecca Landa, PhD, CCC-SLP

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Disqualifiers: Head injury, Serious physical injury, others

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

Compensation: Varies

Number of Visits: 4

700 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a school program designed to help young children with autism improve their language and social skills. It focuses on preschool-aged children who need extra help in these areas. Teachers are trained to use special techniques and get feedback to improve their methods.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the ISC+PRT treatment for autism?

Research shows that Pivotal Response Treatment (PRT), which is part of the ISC+PRT intervention, is effective in improving social communication skills in children with autism. Studies have demonstrated that children participating in PRT made significant gains in social communication, including better eye contact, joint attention, and play skills. ^{1 2 3 4 5}

Is the ISC+PRT Intervention safe for humans?

The safety and tolerability of arbaclofen, a component of the ISC+PRT Intervention, are being examined in clinical trials for autism, but specific safety data is not yet available. ^{1 6 7 8 9}

How is the ISC+PRT treatment for autism different from other treatments?

The ISC+PRT treatment is unique because it combines pivotal response treatment (PRT), which is a parent-delivered intervention aimed at improving social communication, with other social and communication strategies. This approach is distinct in its focus on involving parents directly and using telehealth to deliver the treatment, making it more accessible and potentially more effective in real-world settings. ^{1 3 10 11 12}

Research Team

Rebecca Landa, PhD, CCC-SLP

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria

This trial is for preschoolers aged 3-6 with autism spectrum disorder (ASD) who are enrolled in certain Baltimore County Public School ASD classrooms. Participants must meet specific diagnostic criteria for ASD and have an IQ or Developmental Quotient of at least 40. Preschool educators working in these classrooms can also join.

Inclusion Criteria

My child is between 3 and 6 years old and attends an ASD preschool.

For Teachers: Work in an ASD preschool classroom within a cooperating Baltimore County Public School

Children must meet Autism Diagnostic Observation Schedule-Generic (ADOS) and expert clinical judgment criteria for ASD

Exclusion Criteria

Children and educators may be taken out of the study if they are unable to comply with the study protocol or change schools due to relocation

Children may also be taken out of this study if they sustain a head injury or other serious physical injury during the study or are not being brought in for testing as designated in the protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Children receive 45-90 minutes of intervention in the classroom to increase social and communication skills

At least one school year

Ongoing classroom sessions

Follow-up

Participants are monitored for changes in educator instruction to meet fidelity of intervention

36 weeks

Monitoring at 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks

Treatment Details

Interventions

• ISC+PRT Intervention

Trial Overview The study is testing the ISC+PRT Intervention, a school-based treatment designed to improve language and social skills in children with ASD. The intervention will be refined through educator feedback and aims to be practical for real-world application.

Participant Groups

Group I: ISC+PRT Intervention Experimental Treatment 1 Intervention

For the duration of at least one school year children will receive 45-90 minutes of intervention in the classroom in an attempt to increase social and communication skills.

Group II: Instruction As Usual Active Control 1 Intervention

For the duration of at least one year children will receive the typical classroom instruction

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials

93

Recruited

25,200+

U.S. Department of Education

Collaborator

Trials

87

Recruited

54,500+

Findings from Research

The online model of Pivotal Response Treatment (PRT) delivered through the MindNest Health platform showed good feasibility, with 58% of participants completing the study curriculum, indicating that parents found the online training manageable and engaging.

Parents who participated in the online training reported significant improvements in their confidence and perceptions of treatment effectiveness, with 82% agreeing that the intervention was acceptable, suggesting that this telehealth approach could be a valuable resource for families of autistic children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Delivering Pivotal Response Treatment for Autism Spectrum Disorder via Telehealth: Pilot Pre-Post Study. Drapalik, KN., Grodberg, D., Ventola, P.[2023]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Delivering Pivotal Response Treatment for Autism Spectrum Disorder via Telehealth: Pilot Pre-Post Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial. [2022]

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

The effects of social interactive training on early social communicative skills of children with autism. [2019]

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

A Pivotal Response Treatment Package for Children With Autism Spectrum Disorder: An RCT. [2022]

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

Pivotal Response Treatment: Case Reports. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents With Autism Spectrum Disorders: Study Protocol for AIMS-2-TRIALS-CT1. [2021]

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

A randomized trial comparison of the effects of verbal and pictorial naturalistic communication strategies on spoken language for young children with autism. [2021]

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

Social skills plus relaxation training with a child with ASD in the schools. [2019]

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

A randomized comparison of the effect of two prelinguistic communication interventions on the acquisition of spoken communication in preschoolers with ASD. [2011]

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

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

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

Integrating Language, Pragmatics, and Social Intervention in a Single-Subject Case Study of a Child With a Developmental Social Communication Disorder. [2018]

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

Toward meaningful outcomes in teaching conversation and greeting skills with individuals with autism spectrum disorder. [2018]