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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder; Emotion Regulation
• Intervention / Treatment: Behavioral: Regulating Together (RT); Behavioral: Achieving Independence and Mastery in School (AIMS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regulating Together (RT); Participants will receive Regulating Together -the emotion dysregulation 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.
Active Comparator: Achieving Independence and Mastery in School (AIMS); Participants will receive AIMS, the academic functioning/organizational skill intervention.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Alabama at Birmingham; United States Department of Defense
• Investigators: Principal Investigator: Rebecca Shaffer, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Regulating Together
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Social Behavior; Self-Control; Autism Spectrum Disorder; Emotional Regulation; Non-Medical Public and Private Facilities; Schools
• Other Study ID Numbers: W81XWH-22-1-0168; CDMRP-AR210169 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No