NCT05803369

DOD Regulating Together Intervention

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder
• Emotion Regulation

Interventions

Type	Name	Description
BEHAVIORAL	Regulating Together (RT)	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.
BEHAVIORAL	Achieving Independence and Mastery in School (AIMS)	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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2026-05-31
• Completion: 2026-07-01
• First posted: 2023-04-07
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States