跳至主要内容
临床试验/NCT06489522
NCT06489522
已完成
不适用

Supporting the Implementation of a Parenting Intervention for Mothers With Substance Use Disorder in the Pediatric Medical Home

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 9 人2025年1月17日

概览

阶段
不适用
干预措施
THRIVE
疾病 / 适应症
Substance Use Disorders
发起方
Boston Medical Center
入组人数
9
试验地点
2
主要终点
Acceptability of the THRIVE intervention
状态
已完成
最后更新
25天前

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.

注册库
clinicaltrials.gov
开始日期
2025年1月17日
结束日期
2025年10月30日
最后更新
25天前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

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:

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

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.

研究点 (2)

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