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

NCT04637581 | Completed DMC

• 1 other identifier: STUDY02000324
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Substance-Related Disorders; Depression; Stress Disorders, Post-Traumatic; Child Abuse; Child Neglect

Keywords

substance-related disorders; depression; stress disorders, post-traumatic; child abuse; child neglect

Outcome Measures

Primary Outcomes (2)

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

  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.

  baseline, 6 months, 12 months

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

  A 12-item measure of depression symptoms. Scores range from 0-36. Higher scores indicate higher depression symptoms.

  baseline, 6 months, 12 months

Secondary Outcomes (8)

• 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 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 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

Study Arms (2)

Wraparound

EXPERIMENTAL

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.

Behavioral: Wraparound

treatment-as-usual

NO 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.

Interventions

Wraparound BEHAVIORAL

Wraparound is a 12-month family-driven intensive care coordination model.

Wraparound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator
• Children's Bureau - Administration for Children and Families: collaborator
• Mathematica Policy Research, Inc.: collaborator

Study Sites (4)

Dept of Children Youth and Families

Claremont, New Hampshire, 03743, United States

Location

NH Claremont District Family Courts

Claremont, New Hampshire, 03743, United States

Location

TLC Family Resource Center

Claremont, New Hampshire, 03743, United States

Location

Dartmouth-Hithcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Erin R Barnett, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Health Policy and Clinical Practice

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 20, 2020
• Study Start: November 16, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)