DOD Regulating Together Intervention

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Autism Spectrum Disorder; Emotion Regulation

Treatments: Behavioral: Regulating Together (RT); Behavioral: Achieving Independence and Mastery in School (AIMS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05803369

CDMRP-AR210169 (Other Grant/Funding Number)

W81XWH-22-1-0168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Regulating Together (RT)

Experimental group

Description:

Participants will receive Regulating Together -the emotion dysregulation intervention

Treatment:

Behavioral: Regulating Together (RT)

Achieving Independence and Mastery in School (AIMS)

Active Comparator group

Description:

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

Treatment:

Behavioral: Achieving Independence and Mastery in School (AIMS)