DOD Regulating Together Intervention

NCT05803369 | Active Not Recruiting DMC

• 2 other identifiers: W81XWH-22-1-0168CDMRP-AR210169
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Emotion Regulation

Keywords

Regulating Together

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Children's Organizational Skills Scale (COSS)

  Through study completion, about 29 weeks

• Daily Phone Diary

  Through study completion, about 29 weeks

• Inpatient Hospitalization Rates

  during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult

Study Arms (2)

Regulating Together (RT)

EXPERIMENTAL

Participants will receive Regulating Together -the emotion dysregulation intervention

Behavioral: Regulating Together (RT)

Achieving Independence and Mastery in School (AIMS)

ACTIVE COMPARATOR

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

Behavioral: Achieving Independence and Mastery in School (AIMS)

Interventions

Achieving Independence and Mastery in School (AIMS) BEHAVIORAL

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.

Achieving Independence and Mastery in School (AIMS)

Regulating Together (RT) BEHAVIORAL

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.

Regulating Together (RT)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• United States Department of Defense: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• McKinney WS, Tadevich LJ, Schmitt LM, Horn PS, Ruberg JR, White SW, Reisinger DL, Burkett KW, Sarawgi S, Kang S, Shaffer RC. Study protocol for a randomized controlled trial of Regulating Together (RT), a group therapy for emotion dysregulation in school-age autistic youth and their caregivers. BMC Psychol. 2025 Apr 24;13(1):436. doi: 10.1186/s40359-025-02737-6.

  PMID: 40275407 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Emotional Regulation

Interventions

Schools

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

• Rebecca Shaffer

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 7, 2023
• Study Start: August 1, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)