Supporting the Implementation of a Parenting Intervention for Mothers With Substance Use Disorder in the Pediatric Medical Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Acceptability of the THRIVE intervention
研究概览
简要总结
Children of mothers with substance use disorder (SUD) constitute a growing and highly vulnerable population. Evidence-based parenting interventions have the potential to both support parents' recovery and mental health by helping them cope with stress of parenthood and promote the optimal development of their children by supporting responsive parenting. The Supporting Our Families through Addiction and Recovery (SOFAR) pediatric medical home for families and children impacted by SUDs, with integrated behavioral health (IBH), provides an opportune setting for addressing the needs of mothers and children impacted by SUDs. While many families are thriving in the program, there is a strong unmet need for evidence-based parent-training interventions, particularly during the preschool period.
This study aims to evaluate the implementation of a brief, parent child interaction therapy (PCIT)-based intervention, entitled Threat, harm, risk, investigation, vulnerability and engagement (THRIVE), that will be offered in the SOFAR Clinic at Boston Medical Center. THRIVE is a safe, 6-session telehealth intervention that has been tested in pediatric and community-based settings. The evidence-based suggests that THRIVE is associated with significant improvements in child behaviors and parenting stress.
The investigators hypothesize that offering THRIVE through the SOFAR pediatric primary care program will be feasible and acceptable, improving access to and engagement in evidence-based parenting interventions among mothers with substance use disorder who receive parenting support through our integrated behavioral health model. In addition to studying the implementation of this evidence-based intervention, this study will allow the researchers to test data collection procedures (pre and post-interventions assessments) to inform a future clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •≥ 18 years of age
- •Mother to an index child between 3 years, 0 months to 6 years, 11 months of age who receives primary care at Boston Medical Center
- •Primary caregiver to the index child,
- •Engaged in formal SUD recovery supports (e.g., medication for opioid use disorder, support groups specific to people in recovery and falls into one of these two enrollment groups: A) "high-risk" substance use disorder defined >=1 episode of relapse within the past two years OR B) "low-risk" defined as zero episodes of relapse within the past two years.
- •Between 3 years, 0 months to 6 years, 11 months of age,
- •Enrolled mother is primary caregiver.
- •THRIVE Therapist:
- •Embedded social worker in the SOFAR program delivering the THRIVE intervention
- •Clinical Stakeholders:
- •Patient Navigators, program manager, pediatricians, peer recovery coaches involved in the care of mother-child dyads in the SOFAR Program.
排除标准
- •Has an index child who has complex medical problems (e.g., autism spectrum disorder) that significantly impact the child's ability to interact with the parent (determination by child's primary care pediatrician)
- •Severe cognitive limitation or medical or psychiatric condition that limits their capacity to provide informed consent
- •Concurrent participation in another parent training intervention
- •Has any complex medical problems (as assessed by their pediatrician) that significantly impact the child's ability to interact with the mother.
研究组 & 干预措施
Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) intervention
The THRIVE intervention will be offered by a trained therapist to participants (mother-child dyads) in the SOFAR Clinic.
干预措施: THRIVE (Behavioral)
结局指标
主要结局
Acceptability of the THRIVE intervention
时间窗: 12 months
The Therapy Attitude Inventory survey will be used to collect assess mother/birthing parent acceptability of the THRIVE intervention. It is a 16 item instrument with 5 potential response per Question. Scores can range from 16 to 80 and higher scores are associated with higher acceptability.
Total number of THRIVE intervention sessions
时间窗: 12 months
The total number of sessions completed will be abstracted from the study records.
Fidelity of the THRIVE intervention
时间窗: 12 months
The Treatment Integrity Checklist will be used to assess fidelity. It will be completed by research staff via review of video-recorded THRIVE sessions to monitor adherence to THRIVE core components.
Feasibility of the THRIVE intervention based on enrollment
时间窗: 12 months
The number of families ineligible, approached, and enrolled will be documented from study records.
Duration of THRIVE intervention sessions
时间窗: 12 months
The duration of the sessions will be documented in minutes.
Percent of days homework completed
时间窗: 12 months
Percent of days homework completed will be obtained from study records
Feasibility of the THRIVE intervention based on retention
时间窗: 12 months
Retention will be assessed by the time to loss of follow-up.
Perceived reasons for discontinuation of THRIVE
时间窗: 12 months
The perceived reasons for discontinuation will be documented in the study records.
次要结局
未报告次要终点