Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation (RT-ID)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Grayson Manley, RN
- 电话号码:816-816-6967
- 邮箱:gmanley@cmh.edu
学习地点
-
-
Missouri
-
Kansas City、Missouri、美国、64108
- 招聘中
- Children's Mercy
-
接触:
- Grayson Manley, RN
- 电话号码:816-816-6967
- 邮箱:gmanley@cmh.edu
-
首席研究员:
- Walker McKinney, PhD
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Children with autism and co-occurring intellectual disability and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
|
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Emotion Dysregulation Inventory - Reactivity
大体时间:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinician Global Impressions - Improvement (CGI-I)
大体时间:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Emotion Regulation Skills Test
大体时间:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
大体时间:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Aberrant Behavior Checklist, 2nd Edition (ABC-2)
大体时间:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Parenting Stress Index, 4th Edition, Short Form
大体时间:From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Caregiver and Child Readiness and Satisfaction Surveys
大体时间:From enrollment to end of follow up at 15 weeks
|
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.
|
From enrollment to end of follow up at 15 weeks
|
合作者和调查者
合作者
调查人员
- 首席研究员:Walker McKinney, PhD、Children's Mercy
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00004069
- KL2TR002367 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.