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Wraparound Intervention for Families with Substance Use Disorders
N/A
Waitlist Available
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
No Placebo-Only Group
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.
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.
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Wraparound
2020
N/A
~80
Find a Location
Who is running the clinical trial?
Dartmouth CollegeOTHER
86 Previous Clinical Trials
1,419,665 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterLead Sponsor
539 Previous Clinical Trials
2,539,692 Total Patients Enrolled
Mathematica Policy Research, Inc.OTHER
67 Previous Clinical Trials
31,130,188 Total Patients Enrolled
Children's Bureau - Administration for Children and FamiliesOTHER
22 Previous Clinical Trials
39,382 Total Patients Enrolled
Erin R Barnett, PhDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My parent or guardian is at least 18 years old.My child is not in residential care or will return home within 2 months.My parent/guardian can understand and consent to research.My parent or guardian can understand and agree to research participation.My child's guardian will not be home within 2 months due to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: treatment-as-usual
- Group 2: Wraparound
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.