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DOD Regulating Together Intervention

Primary Purpose

Autism Spectrum Disorder, Emotion Regulation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regulating Together (RT)
Achieving Independence and Mastery in School (AIMS)
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Regulating Together

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regulating Together (RT)

Achieving Independence and Mastery in School (AIMS)

Arm Description

Participants will receive Regulating Together -the emotion dysregulation intervention

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Daily Phone Diary
Phone interview administered by staff that documents Frequency and Intensity of Behavioral and Emotional Outbursts over a 2 day period.
Inpatient Hospitalization Rates
chart review and caregiver report for any psychiatric hospitalizations

Full Information

First Posted
March 14, 2023
Last Updated
March 27, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
United States Department of Defense, University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05803369
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
United States Department of Defense, University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Emotion Regulation
Keywords
Regulating Together

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regulating Together (RT)
Arm Type
Experimental
Arm Description
Participants will receive Regulating Together -the emotion dysregulation intervention
Arm Title
Achieving Independence and Mastery in School (AIMS)
Arm Type
Active Comparator
Arm Description
Participants will receive AIMS, the academic functioning/organizational skill intervention.
Intervention Type
Behavioral
Intervention Name(s)
Regulating Together (RT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Achieving Independence and Mastery in School (AIMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emotion Dysregulation Inventory- Reactivity
Description
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.
Time Frame
Through study completion, about 29 weeks
Secondary Outcome Measure Information:
Title
Children's Organizational Skills Scale (COSS)
Description
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.
Time Frame
Through study completion, about 29 weeks
Title
Daily Phone Diary
Description
Phone interview administered by staff that documents Frequency and Intensity of Behavioral and Emotional Outbursts over a 2 day period.
Time Frame
Through study completion, about 29 weeks
Title
Inpatient Hospitalization Rates
Description
chart review and caregiver report for any psychiatric hospitalizations
Time Frame
during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Fassler
Phone
5138033580
Email
carrie.fassler@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Shaffer
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Fassler
Phone
513-803-3580
Email
carrie.fassler@cchmc.org
First Name & Middle Initial & Last Name & Degree
Rebecca Shaffer, Psy.D.

12. IPD Sharing Statement

Learn more about this trial

DOD Regulating Together Intervention

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