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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, 12 months
Awards & highlights
Study 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 belowSelect...
My parent or guardian is at least 18 years old.
Select...
My parent or guardian can understand and agree to research participation.
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
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 moreTrial 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.
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Who is running the clinical trial?
Dartmouth CollegeOTHER
79 Previous Clinical Trials
1,415,410 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,179 Total Patients Enrolled
Mathematica Policy Research, Inc.OTHER
57 Previous Clinical Trials
6,118,333 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently available for this trial?
"Affirmative, the clinicaltrials.gov page evidences that this research is currently recruiting members. First published on 16th November 2020, and most recently modified on 1st November 2022; 160 participants are being recruited in four locations."
Answered by AI
How many participants are the researchers enrolling in this clinical experiment?
"Affirmative. Clinicaltrials.gov reflects that this clinical investigation, which was initially listed on November 16th 2020, is currently enrolling subjects. A total of 160 patients are in need of recruitment at 4 different sites."
Answered by AI
What is the primary purpose of this medical research endeavor?
"This medical study will assess the efficacy of a new intervention by monitoring changes in responses to the Center for Epidemiologic Studies Depression Scale related to parental/caregiver depression. Additionally, researchers seek to evaluate shifts in Addiction Severity Index (ASI) scores and Infant-Toddler Sensory Profile (ITSP) data as well as observe changes in child placement duration, number of placement changes, type of placement, and discharge status."
Answered by AI
Who else is applying?
What site did they apply to?
Dartmouth-Hithcock
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried many drugs and eventually they lose their effect.
PatientReceived no prior treatments
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