DOD Regulating Together Intervention

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803369
• Other study ID #: W81XWH-22-1-0168
• Secondary ID: CDMRP-AR210169
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: April 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Carrie Fassler
• Phone: 5138033580
• Email: carrie.fassler[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: July 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Emotion Regulation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	United States Department of Defense, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotion Dysregulation Inventory- Reactivity	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.	Through study completion, about 29 weeks
Secondary	Children's Organizational Skills Scale (COSS)	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.	Through study completion, about 29 weeks
Secondary	Daily Phone Diary	Phone interview administered by staff that documents Frequency and Intensity of Behavioral and Emotional Outbursts over a 2 day period.	Through study completion, about 29 weeks
Secondary	Inpatient Hospitalization Rates	chart review and caregiver report for any psychiatric hospitalizations	during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult