Clinical trial NCT05803369: DOD Regulating Together Intervention
Official title: Regulating Together: Randomized Controlled Trial Examining Predictors, Facilitators, and Barriers to Treatment Success in Emotion Dysregulation and Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Emotion Regulation
Keywords: Regulating Together
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of Alabama at Birmingham
First posted: 2023-04-07
Enrollment: 144
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Emotion Dysregulation Inventory- Reactivity
timeFrame: Through study completion, about 29 weeks
Secondary outcomes:
measure: Children's Organizational Skills Scale (COSS)
timeFrame: Through study completion, about 29 weeks
measure: Daily Phone Diary
timeFrame: Through study completion, about 29 weeks
measure: Inpatient Hospitalization Rates
timeFrame: during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Rebecca Shaffer
role: PRINCIPAL_INVESTIGATOR
References: