A Pilot Randomized Control Trial of the Task-Based Grounding Program
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of participants who screen positive
研究概览
简要总结
The purpose of this study is to improve the availability of brief interventions to help children with defiant, aggressive and disruptive behaviors by creating a brief scalable intervention for parents delivered via telehealth. As phase 1 study, we are conducting a 2-arm pilot feasibility RCT in order the intervention, measures, and procedures to be used in a larger efficacy trial. The first arm will include a 3-session behavioral therapy treatment we call Task-Based Grounding and the second arm will be an enhanced treatment as usual comparison group.
详细描述
The investigators have developed a 3-session psychosocial intervention for parents of children between 9-14 with disruptive behaviors. The intervention uses telehealth visits along with written and online resources to teach them parent management skills. To evaluate the acceptability of this intervention and the feasibility of our methods, the investigators will recruit 20 parent-child dyads to participate in this study. This is a mixed methods pilot feasibility RCT design. The investigators designed this study to test the acceptability of the intervention to parents and test the feasibility of our recruitment, retention, measurement, and delivery mechanisms for both the experimental and comparison conditions. The investigators will use a block randomization method to separate parent-child dyads into either treatment or comparison groups. The treatment condition involves 3 telehealth visits and a set of parenting resources. The enhanced treatment as usual condition will involve contact with a "care navigator" that will assess behavior problems in the child and help the parents find an appropriate referral to care in their community. Both groups will be followed for 10 weeks, provide outcome data, and participate in semi-structured qualitative interviews to accept acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participating parent-child dyads must include a child between the ages of 9-14 years old and adult over the age of
- •The child must have a Vanderbilt Oppositional Defiant Disorder score >3
- •The participating caregiver must be a legal guardian of participating child
- •Exclusion Criteria (child refers to the primary participant's child)
- •Child ever been hospitalized for a psychiatric problem
- •Child ever attempted suicide or stated that they had a plan to attempt suicide within the past year.
- •Child ever engaged in self-harm behaviors
- •Child has significant legal history such as adjudicated of a crime or been in diversion
- •Child has ever been diagnosed with: Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, Intellectual Disability or Developmental Delay, Speech or Hearing Delay, Autism Spectrum Disorder, Schizophrenia or another psychotic disorder, A substance abuse disorder (or had serious concerns about substance use).
- •Parent can communicate in spoken English
- •Parent is under the age of 18.
排除标准
- 未提供
结局指标
主要结局
Number of participants who screen positive
时间窗: Through study completion, approximately 5 months.
Feasibility of recruitment will be measured by number of participants who screen positive
Fidelity of the training provided
时间窗: Through study completion, approximately 5 months.
as measured by having a trained listener code and score fidelity using a checklist developed specifically for the content of each session. Audio recording of intervention sessions will be used. There are 35 items on the checklist, each worth 1pt. Score will be in terms of percentage, with a minimum score of 0 and a maximum score 100%.
Intervention acceptability as measured by the Treatment Evaluation Inventory Short Form
时间窗: Follow-up/post intervention (up to 10 weeks)
as measured by Treatment Evaluation Inventory Short Form post intervention which measures intervention acceptance. The established cut off scores for determining if a treatment is acceptable is a score of 27. Min score possible is 0, max score possible is 32. Higher scores indicate greater acceptability.
Intervention Acceptability as measured by the Therapy Attitude Inventory
时间窗: Follow-up/post intervention (up to 10 weeks)
as measured by the Therapy Attitude Inventory post intervention which measures acceptability of behavioral parent trainings. Min score of 1 is possible, max score of 50 is possible. Higher scores indicate greater acceptability.
Change from Baseline Session attendance at visit 3
时间窗: Session attendance will be taken at Session 1 (week 0) and Session 3 (week 6)
Feasibility of the participant retention in the program will be measured by session attendance by participants
Intervention Acceptability as measured by the Participant Experiences Questionnaire
时间窗: Follow-up/post intervention (up to 10 weeks)
as measured by the Participant Experiences Questionnaire which measures acceptability of each skill module included in the program and is specific to program content. Min score of 0 possible, max score of 36 possible. Higher scores indicate greater acceptability.
Acceptability as measured by qualitative interview
时间窗: Follow-up/post intervention (up to 10 weeks)
as measured by 30 minute semi-structured qualitative interview with participants conducted by a research assistant trained and supervised by the study PI
Number of referred participants
时间窗: Through study completion, approximately 5 months.
Feasibility of recruitment will be measured by number of participants referred
Number of participants who complete all assessment measures
时间窗: Through study completion, approximately 5 months.
Feasibility of assessment measures will be measured by number of participants who complete assessment measures
Number of participants enrolled
时间窗: Through study completion, approximately 5 months.
Feasibility of recruitment will be measured by number of participants enrolled
次要结局
- Adherence to the intervention(Available for completion every day for 10 weeks)
研究者
James T. Craig
Assistant Professor of Psychiatry
Dartmouth-Hitchcock Medical Center