Regulating Together for Autism

Overseen By Carrie Fassler

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Major neuropsychiatric illness, sensory impairment, others

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

Compensation: Varies

Number of Visits: 15

Duration: 5 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two programs designed to help children with autism manage their emotions. The Achieving Independence and Mastery in School (AIMS) program focuses on enhancing school skills, while the Regulating Together (RT) program directly targets emotion regulation. The trial aims to determine which approach better supports emotional and social outcomes. Children with autism who struggle to regulate their emotions may be well-suited for this study. As an unphased trial, it offers participants a unique opportunity to contribute to innovative approaches that could significantly enhance emotional and social skills in children with autism.

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 prior data suggests that the Regulating Together intervention is safe for youth with autism?

A previous study tested the Achieving Independence and Mastery in School (AIMS) program with 21 middle school students with autism. The results showed that participants found the program easy to use and were satisfied with it. No safety concerns arose, indicating that AIMS is well-tolerated.

A telehealth pilot study examined the practicality and acceptability of the Regulating Together (RT) program. Although specific safety details were not mentioned, the study focused on helping autistic children and teens manage their emotions, and no safety issues were noted.

Both AIMS and RT appear safe, as available research reports no negative effects. This suggests these programs are likely well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for autism because they offer new approaches to managing the condition. The "Achieving Independence and Mastery in School" (AIMS) program focuses on improving academic functioning and organizational skills, which are often challenging for individuals with autism. On the other hand, "Regulating Together" (RT) targets emotion dysregulation, a common issue not always addressed by typical behavioral therapies. Unlike standard treatments that may primarily focus on behavioral interventions, these programs aim to equip participants with specific skills to enhance their daily functioning and emotional well-being, potentially leading to a more holistic improvement in quality of life.

What evidence suggests that this trial's treatments could be effective for autism?

Research has shown that the Achieving Independence and Mastery in School (AIMS) program, a treatment option in this trial, helps young people with autism improve skills needed for school success. Studies found that students in AIMS demonstrated small to moderate improvements in managing tasks and organizing activities after the program.

For Regulating Together (RT), another treatment option in this trial, studies suggest it helps young people with autism better manage their emotions. Participants in those studies showed improvements in handling emotional reactions, reducing irritability, and controlling behavior. These findings highlight RT's potential in helping participants manage their emotions more effectively. Overall, both programs provide valuable support for young people with autism in handling school and emotional challenges. ^{1 3 6 7 8}

Who Is on the Research Team?

Rebecca Shaffer

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7889749/

Achieving Independence and Mastery in School: An Open ... This paper reports on an open trial of the intervention with 21 middle-schoolers with ASD. Results suggest high feasibility/satisfaction, and improved EF ...

2. eric.ed.gov eric.ed.gov/?id=ED639585

ED639585 - Achieving Independence and Mastery in School ... Individuals randomized to AIMS improved from baseline to post on academic EF outcome measures with small to moderate effect sizes, compared to ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32809169/

Achieving Independence and Mastery in School - PubMed - NIH This paper reports on an open trial of the AIMS-Outpatient intervention with 21 middle schoolers with ASD. Results suggest high feasibility/satisfaction, and ...

4. withpower.com withpower.com/trial/social-and-academic-interventions-for-autism-spectrum-disorder-dbfdc

Social and Academic Interventions for Autism Spectrum ... What data supports the effectiveness of the treatment Achieving Independence and Mastery in School (AIMS), Building Essential Social Skills for Teens (BESST) ...

5. researchgate.net researchgate.net/publication/375831127_Achieving_Independence_and_Mastery_in_School_A_School-Based_Executive_Function_Group_Intervention_for_Autistic_Middle_Schoolers

Achieving Independence and Mastery in School Individuals randomized to AIMS improved from baseline to post on academic EF outcome measures with small to moderate effect sizes, compared to ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37991661/

A School-Based Executive Function Group Intervention for ... The aim was to assess the initial efficacy of the school-based version of the Achieving Independence and Mastery in School (AIMS) intervention ...

7. aims-ef.com aims-ef.com/what-is-aims/

What is AIMS? AIMS is a school-based program developed to help middle school students with social-communication challenges (such as autism spectrum disorder) achieve ...

8. files.eric.ed.gov files.eric.ed.gov/fulltext/EJ1377938.pdf

School Challenges and Services Related to Executive ... - ERIC Achieving independence and mastery in school: an open trial in the outpatient setting. Journal of. Autism and Developmental Disorders, 51, 1705–1718. Tamm, L ...