Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation (RT-ID)
2026년 9월 1일 업데이트: Walker McKinney, Children's Mercy Hospital Kansas City
Adapting a Group Intervention for Emotion Dysregulation in Autism and Intellectual Disability
The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is:
To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.
연구 개요
상세 설명
Up to ten children with autism and co-occurring Intellectual Disability (ASD + ID) ages 8 to 12 years and their caregivers will be enrolled in the study. This study is being done to develop and test a behavior therapy to help children with ASD + ID calm their emotions. Participants will complete assessments at five time points:
Screening (T1); Week 0: Baseline visit (T2); Week 5: Post Active Treatment (T3); Week 10: 5 week follow-up (T4); and Week 15: 10 week follow-up (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.
연구 유형
중재적
등록 (추정된)
10
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Grayson Manley, RN
- 전화번호: 816-816-6967
- 이메일: gmanley@cmh.edu
연구 장소
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Missouri
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Kansas City, Missouri, 미국, 64108
- 모병
- Children's Mercy
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연락하다:
- Grayson Manley, RN
- 전화번호: 816-816-6967
- 이메일: gmanley@cmh.edu
-
수석 연구원:
- Walker McKinney, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Child Participant Inclusion Criteria:
- Males, females, or non-binary youth between 8 and 12 years of age
- Confirmed diagnosis of Autism Spectrum Disorder (ASD)
- Confirmed diagnosis of Intellectual Disability
- Fluent in spoken English.
- Use of flexible phrase speech or greater
- Meeting clinically significant emotion dysregulation criteria
- Willing to participate in twice weekly 90-minute sessions
- Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable
- Parent, guardian, or legally authorized representative (LAR) must provide written permission on behalf of the participant
Child Participant Exclusion Criteria:
- Initiation of new psychosocial intervention within 30 days prior to first day of treatment
- Presence of physical aggression in the child directed towards a peer outside the home (i.e., non-siblings) that resulted in injury within 30 days prior to screening. Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to the group sessions will be reviewed by the study team on an individual basis.
- 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
Caregiver Inclusion Criteria:
- Age ≥ 18 years
- Lives and cares for their child with ASD+ID for > 50% of the year
- Fluent in spoken English.
- Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly
Caregiver Exclusion Criteria:
-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Children with autism and co-occurring intellectual disability and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
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Regulating Together is the original curriculum developed for autistic youth that uses evidence-based therapeutic strategies including relaxation techniques, parent management training, and mindfulness to help regulate emotions.
This study will adapt the original Regulating Together curriculum to focus on behavioral interventions to treat emotion dysregulation in Autism with a co-occurring intellectual disability.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Emotion Dysregulation Inventory - Reactivity
기간: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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The Emotion Dysregulation Inventory consists of two subscales.
The investigators will use the Reactivity subscale which captures poorly regulated negative emotional responses and a dysphoria subscale characterized by increased negative affect and lack of motivation.
Minimum raw score: 0; Maximum raw score: 96; Higher scores reflect higher emotional reactivity.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinician Global Impressions - Improvement (CGI-I)
기간: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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A trained, independent clinician will rate the CGI at T3 and T5.
The CGI-I provides a qualitative measure of treatment response through a rating from 1=very much improved to 7=very much worse.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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Emotion Regulation Skills Test
기간: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
기간: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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Caregiver-report measures to measure change in internalizing symptoms.
For both measures: minimum raw value: 13; maximum raw value: 65; higher scores reflect greater anxiety/depression
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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Aberrant Behavior Checklist, 2nd Edition (ABC-2)
기간: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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Irritability subscale; a caregiver-report measures to measure change in irritability and related challenging behaviors.
Minimum score: 0; Maximum score: 45; higher scores reflect greater irritability
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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Parenting Stress Index, 4th Edition, Short Form
기간: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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A caregiver-report questionnaire measuring the magnitude of stress in the parent-child system.
Minimum score: 36; Maximum score: 180; Higher scores reflect greater parental stress
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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Caregiver and Child Readiness and Satisfaction Surveys
기간: From enrollment to end of follow up at 15 weeks
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The investigators will assess acceptability as reflected in the average caregiver and child satisfaction rating measured using two study-specific measures.
Caregivers will complete the Caregiver Readiness and Satisfaction Survey and children will complete the Child Readiness and Satisfaction Survey.
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From enrollment to end of follow up at 15 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Walker McKinney, PhD, Children's Mercy
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 10월 1일
기본 완료 (추정된)
2028년 6월 1일
연구 완료 (추정된)
2028년 8월 1일
연구 등록 날짜
최초 제출
2026년 5월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 28일
처음 게시됨 (실제)
2026년 6월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 1일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00004069
- KL2TR002367 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Risk for participant identification due to small sample and narrow geographic area
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .