CompletedNot Applicable

Wraparound for High-risk Families with Substance Use Disorders: Examining Family, Child, and Parent Outcomes

United States73 participantsStarted 2020-11-16

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in responses to the Adult-Adolescent Parenting Inventory-2nd version related to parenting strengths and needs

Timeframe: baseline, 6 months, 12 months

Change in responses to the Center for Epidemiologic Studies Depression Scale related to parent/caregiver depression

Timeframe: baseline, 6 months, 12 months

Trial details

NCT IDNCT04637581

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Substance-Related Disorders trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

What they're measuring

Change in responses to the Adult-Adolescent Parenting Inventory-2nd version related to parenting strengths and needs

Timeframe: baseline, 6 months, 12 months

Change in responses to the Center for Epidemiologic Studies Depression Scale related to parent/caregiver depression

Timeframe: baseline, 6 months, 12 months

Wraparound for High-risk Families with Substance Use Disorders: Examining Family, Child, and Parent Outcomes

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Wraparound for High-risk Families with Substance Use Disorders: Examining Family, Child, and Parent Outcomes

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria