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Wraparound Intervention for Families with Substance Use Disorders

N/A
Recruiting
Led By Erin R Barnett, PhD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parent/guardian is age 18 or older.
Parent/guardian has cognitive capacity to consent to research.
Must not have
Exclude if the parent/guardian lacks the cognitive capacity to provide informed consent to research.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, 12 months
Awards & highlights

Summary

This trial is testing whether the Wraparound intervention can help families with 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 have better parenting and family functioning outcomes, child safety, permanency, and well-being, and parental recovery than families receiving treatment as usual.

Who is the study for?
Parents or guardians with children up to age 17, living in specific areas of New Hampshire or Vermont, who have substance use disorders and are at risk of having their child placed out of the home. Participants must be over 18, able to consent, and not planning to move soon. Children already in foster care can join if a birth parent participates.Check my eligibility
What is being tested?
The trial is testing 'Wraparound,' a family-centered support process lasting for 12 months aimed at improving parenting and family functioning. It compares families receiving Wraparound with those getting usual treatment to see which group fares better in terms of parenting outcomes and child well-being.See study design
What are the potential side effects?
Since Wraparound is a supportive intervention rather than a medication, it does not have physical side effects. However, participants may experience emotional discomfort when addressing personal issues during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My parent or guardian is at least 18 years old.
Select...
My parent or guardian can understand and agree to research participation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My parent/guardian can understand and consent to research.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in responses to the Adult-Adolescent Parenting Inventory-2nd version related to parenting strengths and needs
Change in responses to the Center for Epidemiologic Studies Depression Scale related to parent/caregiver depression
Secondary outcome measures
Changes in child placement duration, number of placement changes, type of placement, discharge status
Changes in child protection screened in referrals, type of allegation, disposition of allegation
Changes in removal from birth family as an indicator of child safety and permanency
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WraparoundExperimental Treatment1 Intervention
Wraparound is a 12-month intervention including a family-centered discovery process to identify values, needs, and strengths to help the family be successful in reaching family functioning and parental recovery goals; weekly or twice weekly family meetings with the Wraparound coordinator; intensive care coordination among systems and providers (substance use disorder, mental health, schools, pediatrics, homeless shelters, etc.); and bi-monthly family-centered team meetings (including the family's natural and professional supports) to discuss strategies, progress and continued needs. Wraparound coordinators (2) work with up to 10 families at a time and receive extensive training (including observation) and supervision by expert trainers at University of New Hampshire.
Group II: treatment-as-usualActive Control1 Intervention
The treatment-as-usual group will receive a packet of local services and referral contacts and "treatment as usual" as directed by any healthcare providers working with the family. The project team will contact treatment-as-usual families on a monthly basis to confirm any services the family may be receiving, provide reminders of scheduled assessment dates, and give small incentives ($10 gift card) when families report changes in contact information to reduce risk for loss to follow-up.

Find a Location

Who is running the clinical trial?

Dartmouth CollegeOTHER
84 Previous Clinical Trials
1,419,303 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterLead Sponsor
530 Previous Clinical Trials
2,544,774 Total Patients Enrolled
Mathematica Policy Research, Inc.OTHER
57 Previous Clinical Trials
6,118,333 Total Patients Enrolled

Media Library

Wraparound Clinical Trial Eligibility Overview. Trial Name: NCT04637581 — N/A
Substance Use Disorders Research Study Groups: treatment-as-usual, Wraparound
Substance Use Disorders Clinical Trial 2023: Wraparound Highlights & Side Effects. Trial Name: NCT04637581 — N/A
Wraparound 2023 Treatment Timeline for Medical Study. Trial Name: NCT04637581 — N/A
~7 spots leftby Sep 2024