Regulating Together for Autism

Overseen by Rebecca Shaffer

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Major neuropsychiatric illness, sensory impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a program called Regulating Together, which helps children with autism manage their emotions. It targets kids aged 8-12 who struggle with emotional regulation. The program teaches them to recognize and control their feelings.

Will I have to stop taking my current medications?

The trial requires that families keep prescribed medications stable, so you won't need to stop taking your current medications.

What data supports the effectiveness of the treatment Achieving Independence and Mastery in School (AIMS) for autism?

Research shows that interventions combining social communication and self-regulation strategies are effective in teaching these skills to children with autism, as seen in a study where children and parents improved their knowledge and maintained these skills over time. ^{1 2 3 4 5}

How does the Regulating Together treatment for autism differ from other treatments?

The Regulating Together treatment is unique because it combines elements of social communication and self-regulation interventions, focusing on teaching these skills to both children with autism and their parents. This approach emphasizes parent involvement and aims to improve social communication and self-regulation knowledge, which is different from many other treatments that may not involve parents as actively. ^{1 3 6 7 8}

Research Team

Rebecca Shaffer

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for English-speaking caregivers and their children with autism spectrum disorder (ASD) who are 11-12 years old, have functional verbal communication, an IQ score of 65 or higher, and issues with emotion regulation. Families must commit to twice-weekly sessions and keep current medications stable. Children with major sensory impairments, recent psychosocial interventions, a history of serious aggression, or other major neuropsychiatric illnesses are excluded.

Inclusion Criteria

My guardian and I (if I'm 11-12 years old) have given written consent to participate.

Caregivers and child are fluent in speaking English

Child functional verbal communication, confirmed via appropriateness for an Autism Diagnostic Observation Schedule (ADOS-2) Module 3

Exclusion Criteria

I have a major mental health condition needing different treatment.

I do not have major sensory impairments like blindness or severe hearing loss.

I started a new mental health support program within the last 30 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

0 weeks

1 visit (in-person)

Baseline

Baseline assessments are conducted

1 week

1 visit (in-person)

Treatment

Participants receive 5 weeks of intervention, twice per week

5 weeks

10 visits (in-person)

Post Active Treatment

Post-treatment assessments including semi-structured interviews

1 week

1 visit (in-person)

Post Generalization

Assessments to evaluate generalization of skills

9 weeks

1 visit (in-person)

Follow-up

Final outcome visit to monitor long-term effects

13 weeks

1 visit (in-person)

Treatment Details

Interventions

• Achieving Independence and Mastery in School (AIMS) (Behavioural Intervention)
• Regulating Together (RT) (Behavioural Intervention)

Trial Overview The study aims to validate 'Regulating Together' (RT), an intervention designed to help youth with ASD manage their emotions better compared to 'Achieving Independence and Mastery in School' (AIMS). Participants will attend twice-weekly sessions for either RT or AIMS based on random assignment.

Participant Groups

Group I: Regulating Together (RT) Experimental Treatment 1 Intervention

Participants will receive Regulating Together -the emotion dysregulation intervention

Group II: Achieving Independence and Mastery in School (AIMS) Active Control 1 Intervention

Participants will receive AIMS, the academic functioning/organizational skill intervention.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Steve Davis

Children's Hospital Medical Center, Cincinnati

Chief Executive Officer since 2021

MD

Daniel Ostlie

Children's Hospital Medical Center, Cincinnati

Chief Medical Officer

MD from University of North Dakota

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

The parent-assisted blended intervention, called the Growing, Learning, and Living With Autism Group, was effective in improving social communication and self-regulation knowledge in 17 first and second graders with autism spectrum disorder (ASD) and their parents, as shown by pre- and post-intervention assessments.

The positive effects of the intervention were maintained at 3 and 6 months after the program, indicating its potential long-term benefits, although the intervention did not significantly improve parent-child interactions as observed in video recordings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy Study of a Social Communication and Self-Regulation Intervention for School-Age Children With Autism Spectrum Disorder: A Randomized Controlled Trial. Nowell, SW., Watson, LR., Boyd, B., et al.[2021]

The primary treatment goal for children with autism is to support their normal development, particularly in intellectual, language, and social skills, while also addressing rigidity and maladaptive behaviors.

A comprehensive therapeutic program should include a thorough diagnostic assessment, specialized educational support, and a home-based program for families to effectively address the needs of autistic children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of autistic children. Rutter, M.[2019]

A study involving 100 children with autism showed that a combination of structured institution-based teaching and family rehabilitation training significantly improved autism-related behaviors and skills compared to a control group that only received the teaching program.

After 12 months, the combination therapy group had lower scores on the Autism Behavior Checklist and Autism Treatment Evaluation Checklist, indicating reduced autism symptoms, and higher scores on the Psychoeducational Profile, suggesting improved developmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of structured institution-based teaching programme combined with family rehabilitation training in treatment of childhood autism]. Liu, C., Lu, B., Zhang, Y., et al.[2015]

An individualized, goal-directed rehabilitation protocol significantly improved functional outcomes in 32 children with developmental delays over a 3-month period, as measured by various assessment scales.

The study found that while the rehabilitation goals were achieved, improvements in these goals did not directly correlate with changes in overall functional levels, highlighting the importance of caregiver involvement in the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of individualized, goal directed institutional based rehabilitation programme in children with developmental delay disorders, in a region with limited rehabilitation accessibility. Mishra, K., Siddharth, V., Elhence, A., et al.[2020]

Children and youth with autism spectrum disorder (ASD) can actively participate in setting their own rehabilitation goals, but there are very few evaluated tools available to support this process.

Visual aids have been identified as one effective strategy to enhance participation in goal setting, highlighting the need for further research to develop and assess more effective tools for engaging children and youth with ASD in their rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing for the future: a review of tools and strategies to support autonomous goal setting for children and youth with autism spectrum disorders. Hodgetts, S., Park, E.[2018]

Preliminary research indicates that the Relationship Development Intervention (RDI) program can significantly enhance the emotional, social, and cognitive skills of children with autism spectrum disorders (ASD) by empowering parents to facilitate their development.

While a controlled study has not yet been conducted, RDI shows promise as a valuable component of a comprehensive treatment plan for ASD, emphasizing the importance of parental involvement and clinician support in the therapeutic process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering families through Relationship Development Intervention: an important part of the biopsychosocial management of autism spectrum disorders. Gutstein, SE.[2022]

The proposed social living complex offers a unique intervention for children with autism spectrum disorder (ASD) and their families by integrating them into a community with typically developing individuals, promoting ongoing social interaction beyond traditional settings.

This initiative also includes support groups for parents of children with ASD, addressing their higher stress levels and feelings of isolation, thereby fostering a supportive environment for both children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Social Living Complex: A New, All Day, Yearlong Intervention Model for Individuals with Autism Spectrum Disorder and Their Parents. Doenyas, C.[2019]

Peer-mediated intervention (PMI) effectively supports children with autism and ADHD in following school routines independently, as demonstrated in a study involving three participants aged 7-8 in Taiwan.

Training typically developing peers to prompt and reinforce their classmates with autism led to positive outcomes, allowing these students to better meet behavioral expectations with less reliance on adult support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Peer-Mediated Intervention to Teach Behavioral Expectations for Two Students on Autism Spectrum and a Student with ADHD in an Inclusive Elementary Classroom in Taiwan. Chen, YL.[2022]

References

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

Efficacy Study of a Social Communication and Self-Regulation Intervention for School-Age Children With Autism Spectrum Disorder: A Randomized Controlled Trial. [2021]

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

The treatment of autistic children. [2019]

3. China pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of structured institution-based teaching programme combined with family rehabilitation training in treatment of childhood autism]. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of individualized, goal directed institutional based rehabilitation programme in children with developmental delay disorders, in a region with limited rehabilitation accessibility. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Preparing for the future: a review of tools and strategies to support autonomous goal setting for children and youth with autism spectrum disorders. [2018]

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

Empowering families through Relationship Development Intervention: an important part of the biopsychosocial management of autism spectrum disorders. [2022]

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

The Social Living Complex: A New, All Day, Yearlong Intervention Model for Individuals with Autism Spectrum Disorder and Their Parents. [2019]

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

Implementation of a Peer-Mediated Intervention to Teach Behavioral Expectations for Two Students on Autism Spectrum and a Student with ADHD in an Inclusive Elementary Classroom in Taiwan. [2022]