Wraparound for High-risk Families with Substance Use Disorders: a Randomized Controlled Trial Examining Family, Child, and Parent Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 8
- 主要终点
- Change in responses to the Center for Epidemiologic Studies Depression Scale related to parent/caregiver depression
研究概览
简要总结
The investigators propose a Hybrid Type 1 effectiveness-implementation quasi-experimental trial. Participants are drawn from two different communities contemporaneously. The intervention participants in one community receive a Wraparound intervention. Comparison group participants drawn from a second matched community receive treatment as usual. With this design, the investigators aim to study outcomes associated with the intervention as well as explore important facilitators and barriers associated with the implementation and other factors associated with reach / participation, engagement and acceptability.
Wraparound is a structured 12-month family-driven "process" that is guided by family goals, includes a team of supports to wrap around families, and coordinates care for families. Wraparound has been primarily delivered and tested with families of older-age children with severe emotional and behavioral needs in an attempt to prevent residential placement. The investigators are interested in testing the model in a sample of families (n=160) affected by substance use disorders who have children placed outside the home or are at risk of such placement. The investigators hypothesize that families receiving Wraparound will obtain better parenting and family functioning outcomes (primary outcome); child safety, permanency, and well-being; and parental recovery than families receiving treatment as usual. The investigators will also explore factors associated with higher levels of engagement and outcomes, including family characteristics, referral sources and hand-off, and similarly, explore barriers and facilitators associated with engagement and/or outcomes.
详细描述
No registry is involved.
The Research Questions include:
- Do families receiving Wraparound intervention achieve higher parenting and family functioning outcomes than treatment as usual?
- Do children of Wraparound families achieve higher levels of child well-being, safety and permanency than those receiving treatment as usual?
- Do parents receiving Wraparound intervention achieve greater reductions in addiction severity, trauma symptoms, and more sustained recovery than those receiving treatment as usual?
- Does participation in a Wraparound lead to greater engagement in services and development of family strengths?
- What factors lead to higher levels of engagement and better outcomes?
- What are the barriers and facilitators associated with engagement and outcomes?
The data collection and analytic plan described in this document include only those activities planned for research questions 1-3.
Recruitment. Enrollment into the study will begin fall 2020 and run through spring 2023 for a total of 30 months. The project has multiple referral sites spanning medical centers, addiction treatment or recovery centers, child protection, family courts, family resource centers, and other social service agencies. The investigators plan for a rolling recruitment process, aiming for 40 participants enrolled per year. (Wraparound case-loads should not exceed 10 families and there are 2 Wraparound coordinators).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Expecting parent or parent/guardian of children birth to age 17 where one or both parents report or screen positively for a substance use disorder (SUD) within the past year, excluding tobacco or cannabis/marijuana as the primary substance.
- •For court guardianship cases and cases where children are in foster care, where one or both birth parents have a substance use disorder, a birth parent is willing to consent to make a good faith effort to be part of the Wraparound process and complete recovery measures.
- •Child(ren) in out-of-home placement or at risk for out of home placement; "at risk" means: 1) strongly considered or have made reports to the New Hampshire Division of Children Youth and Families or the child would be at high risk of removal if not for the intervention. In addition, for guardianship cases, the child's placement with the guardian needs to be at risk for disruption.
- •Parent/guardian is age 18 or older.
- •Parent/guardian has cognitive capacity to consent to research.
- •For intervention: Parent/guardian lives in Sullivan or Lower Grafton counties in New Hampshire (Division of Children Youth and Families Claremont District Office catchment area) or Windsor, upper Windham, and lower Orange County, VT (Hartford and Springfield VT Department of Children and Families district office catchment areas). For the comparison group, parents live within the catchment area of the Keene, NH DCYF district office (Cheshire County, NH and surrounding towns). Parents do not have plans to move outside of these towns within the next 12 mo. *If the parent lives within the catchment area, and the child is placed outside of the catchment area, the foster parent (outside of catchment area) must be willing to make a good faith effort to be involved with the Wraparound process and complete the child well-being measures.
排除标准
- •Exclude if at time of eligibility assessment into the study, the Termination of Parental Rights (TPR) hearing is scheduled. *If the termination hearing is scheduled later, during the course of the intervention, the investigators will continue working with the child(ren) or family if the new guardian with legal authority to consent to the study consents.
- •Exclude if the child is in residential care and there is no plan for the child to return home within 2 months.
- •Exclude if the parent/guardian is in residential treatment and there is no plan for the parent/guardian to return home within 2 months.
- •Exclude if the parent/guardian lacks the cognitive capacity to provide informed consent to research.
结局指标
主要结局
Change in responses to the Center for Epidemiologic Studies Depression Scale related to parent/caregiver depression
时间窗: baseline, 6 months, 12 months
A 12-item measure of depression symptoms. Scores range from 0-36. Higher scores indicate higher depression symptoms.
Change in responses to the Adult-Adolescent Parenting Inventory-2nd version related to parenting strengths and needs
时间窗: baseline, 6 months, 12 months
assesses 5 parenting constructs:1) inappropriate expectations of child,2) lack of empathy towards child's needs,3)belief in corporal punishment, 4) reverses parent-child roles, 5) restricts child's power and independence. Range for each scale is 1-10. Lower numbers indicate higher abuse risk.
次要结局
- Changes in the Child Behavior Checklist (CBCL) *two versions: 18 mo - 5 years 12 months and 6-18 years related to child functioning and well-being(baseline, 6 months, 12 months)
- Changes in removal from birth family as an indicator of child safety and permanency(baseline, 6 months, 12 months)
- Changes in the Infant-Toddler Sensory Profile (ITSP) *two versions: 0-6 months and 7-17 months (scale goes through 34 months but at 18 months participants switch to the Child Behavior Checklist) related to infant and toddler functioning / well-being(baseline, 6 months, 12 months)
- Changes in child placement duration, number of placement changes, type of placement, discharge status(baseline, 6 months, 12 months)
- Changes in child protection screened in referrals, type of allegation, disposition of allegation(baseline, 6 months, 12 months)
- Substance use treatment episode information as an indicator of parent/caregiver engagement in substance use treatment(baseline, 6 months, 12 months)
- Changes in the Addiction Severity Index (ASI), a measure of addiction severity in parents/caregivers(baseline, 6 months, 12 months)
- Changes in the Trauma Symptom Checklist-40, a measure of traumatic stress symptoms in parents/caregivers(baseline, 6 months, 12 months)
研究者
Erin R. Barnett
Assistant Professor of Psychiatry and Health Policy and Clinical Practice
Dartmouth-Hitchcock Medical Center