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Active, Not Recruiting

NCT Number: NCT05803369

DOD Regulating Together Intervention

Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Emotion Regulation Emotional Regulation Mental Disorders Neurodevelopmental Disorders Self-Control Social Behavior

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

144 children ages 8-12 years old with autism spectrum disorder will be enrolled in the study and randomized to Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS) groups. Participants will complete assessments at five time points: Screen (T1) Week 0 - where they will complete consent; Baseline (T2); Week 7: Post Active Treatment (includes semi-structured interviews) (T3); Week 16: Post Generalization (T4); Week 29: Final outcome visit (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of autism spectrum disorder (ASD)
  • A Full Scale IQ score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) or other previous Weschler IQ test
  • Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R).
  • 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.
  • Family willing to keep prescribed medication and outside interventions stable
  • willing to participate in twice weekly 90-minute sessions of either Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS).
  • The guardian must provide written informed consent on behalf of the participant and the participants ages 11-12 years old must provide written informed assent to participate.

Exclusion criteria

  • Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment.
  • any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury
  • Presence of comorbid major neuropsychiatric illness warranting other treatment approaches.
  • Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss

Treatment and study plan

Regulating Together (RT)

Behavioral

Regulating Together is an intensive outpatient group treatment targeting emotion dysregulation. It engages both caregivers and children and utilizes evidence-based intervention techniques including cognitive behavioral therapy (CBT), visuals, reinforcements, and scaffolding, and newer interventions such as mindfulness and acceptance-based therapy.

Achieving Independence and Mastery in School (AIMS)

Behavioral

AIMS is a school-based program developed to help students with social-communication challenges (such as autism spectrum disorder) achieve academic success. It is well-established and has been used with autistic youth, both in schools and in outpatient settings.

Primary outcomes

  1. Emotion Dysregulation Inventory- Reactivity

    Time frame: Through study completion, about 29 weeks

    13-item parent report measure that captures negative emotional responses and Dysphoria characterized by increased negative affect and lack of motivation. Higher scores mean higher emotional reactivity.

Secondary outcomes

  1. Children's Organizational Skills Scale (COSS)

    Time frame: Through study completion, about 29 weeks

    Used to measure outcomes from AIMS intervention. It is a rating scale completed by parents and teachers which yields three factors measuring Organized Actions, Task Planning, and Memory and Materials Management. Higher scores mean higher organizational skills.

  2. Daily Phone Diary

    Time frame: Through study completion, about 29 weeks

    Phone interview administered by staff that documents Frequency and Intensity of Behavioral and Emotional Outbursts over a 2 day period.

  3. Inpatient Hospitalization Rates

    Time frame: during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult

    chart review and caregiver report for any psychiatric hospitalizations

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • United States Department of Defense
  • University of Alabama at Birmingham

Registry information

Official study title

Regulating Together: Randomized Controlled Trial Examining Predictors, Facilitators, and Barriers to Treatment Success in Emotion Dysregulation and Autism Spectrum Disorder (ASD)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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