Social and Communication Intervention for Autism

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new school-based treatment, the ISC+PRT Intervention, designed to boost language and social skills in young children with autism spectrum disorder (ASD). The treatment includes daily classroom activities lasting 45-90 minutes to help children communicate and interact better. Educators will provide regular feedback to refine the program and ensure its practicality for real-world use. Children aged 3 to 6 who attend a Baltimore County Public School ASD preschool classroom and have been diagnosed with ASD might be a good fit for this study. As an unphased trial, this study offers a unique opportunity for children to benefit from innovative educational strategies tailored to enhance their communication and social skills.

Will I have to stop taking my current medications?

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

What prior data suggests that this intervention is safe for preschool-aged children with autism?

Research has shown that Pivotal Response Treatment (PRT), a key component of the ISC+PRT program, is generally well-tolerated by children with autism spectrum disorder (ASD). Studies have found that children in PRT improve their social communication skills, such as making better eye contact and engaging in joint attention, without major side effects. One study found that PRT effectively enhanced various social and communication skills within three months. No clear evidence of serious side effects has emerged from these treatments, suggesting they are safe for children with ASD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ISC+PRT Intervention for autism because it combines innovative classroom-based treatments to enhance social and communication skills. Unlike traditional therapies that might take place outside the school setting, this approach integrates directly into the classroom, providing 45-90 minutes of targeted intervention each day. This method not only aims to improve interaction skills but also does so in the natural social environment of the child, potentially leading to more effective and lasting improvements.

What evidence suggests that the ISC+PRT Intervention is effective for improving language and social skills in children with autism?

Research shows that the ISC+PRT Intervention, which combines social and communication techniques with Pivotal Response Treatment (PRT), may help children with autism spectrum disorder (ASD). In this trial, some participants will receive the ISC+PRT Intervention to boost social and communication skills in a school setting. Studies have found that PRT can greatly improve social skills, such as making eye contact and sharing attention with others, in children with ASD. In some cases, PRT has outperformed other methods, leading to noticeable improvements in both specific and general areas of development. While results vary for language and communication skills, many children in PRT have made significant progress. Overall, the ISC+PRT Intervention aims to enhance these benefits, making it easier for teachers to implement. ^{1 2 3 4 6}

Who Is on the Research Team?

Rebecca Landa, PhD, CCC-SLP

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4194254/

A Randomized Clinical Trial Comparison Between Pivotal ... The data showed that the PRT approach was significantly more effective in improving targeted and untargeted areas after three months of intervention. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01591707

Study Details | NCT01591707 | Evaluating a Social and ... The purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children ...

3. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-6-2012-1408d

Social and Communication Intervention for Autism Studies have demonstrated that children participating in PRT made significant gains in social communication, including better eye contact, joint attention, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5488784/

Pivotal response treatment for autism spectrum disorder PRT is an evidence-based behavioral intervention based on applied behavior analysis principles aimed to improve social communication skills in individuals with ...

5. ies.ed.gov ies.ed.gov/ncee/wwc/EvidenceSnapshot/668

WWC | Pivotal Response Training PRT was found to have no discernible effects on communication/language competencies for children and students with an autism spectrum disorder. Pivotal response ...

6. med.stanford.edu med.stanford.edu/content/dam/sm/sasnl/documents/8_peds_20190178.pdf

A Pivotal Response Treatment Package for Children With ... WHAT THIS STUDY ADDS: This study reveals the efficacy of a pivotal response treatment package combining parent training and clinician- delivered intervention ...