RECRUITING

DOD Regulating Together Intervention

Conditions

Autism Spectrum Disorder Emotion Regulation Regulating Together

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-01

Study Completion:2026-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05803369

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Carrie Fassler

CONTACT

5138033580

carrie.fassler@cchmc.org

Principal Investigator

Rebecca Shaffer

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Rebecca Shaffer, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01

Study Completion Date2026-07-01

Study Record Updates

Study Start Date2022-08-01

Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

Regulating Together

Additional Relevant MeSH Terms

Autism Spectrum Disorder
Emotion Regulation