DOD Regulating Together Intervention

Not Applicable

Recruiting

• Conditions: Emotion Regulation; Autism Spectrum Disorder
• Interventions: Behavioral: Regulating Together (RT); Behavioral: Achieving Independence and Mastery in School (AIMS)

• Registration Number: NCT05803369
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2026-03-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regulating Together (RT)	Regulating Together (RT)	Participants will receive Regulating Together -the emotion dysregulation intervention
Achieving Independence and Mastery in School (AIMS)	Achieving Independence and Mastery in School (AIMS)	Participants will receive AIMS, the academic functioning/organizational skill intervention.

Primary Outcome Measures

Name	Time	Method
Emotion Dysregulation Inventory- Reactivity	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 Outcome Measures

Name	Time	Method
Inpatient Hospitalization Rates	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
Children's Organizational Skills Scale (COSS)	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.
Daily Phone Diary	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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States