Depression Clinical Trial
Official title:
Wraparound for High-risk Families With Substance Use Disorders: A Randomized Controlled Trial Examining Family, Child, and Parent Outcomes
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Parent/guardian is age 18 or older. 5. Parent/guardian has cognitive capacity to consent to research. 6. 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. Exclusion Criteria: 1. 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. 2. Exclude if the child is in residential care and there is no plan for the child to return home within 2 months. 3. Exclude if the parent/guardian is in residential treatment and there is no plan for the parent/guardian to return home within 2 months. 4. Exclude if the parent/guardian lacks the cognitive capacity to provide informed consent to research. |
Country | Name | City | State |
---|---|---|---|
United States | Dept of Children Youth and Families | Claremont | New Hampshire |
United States | NH Claremont District Family Courts | Claremont | New Hampshire |
United States | TLC Family Resource Center | Claremont | New Hampshire |
United States | Dartmouth-Hithcock | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Children's Bureau - Administration for Children and Families, Dartmouth College, Mathematica Policy Research, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | Measures general, auditory, visual, touch, movement, and oral processing (and 7-17 mo. measures behavioral processing). Domains of processing are transferred to create 4 subscales: seeking, avoiding, sensitivy, registration. Raw scores on these subscales range from 7-35, 11-55, 13-65, 11-55 respectively. Scorers look up Standard Deviations of scores using manual. Scores that fall within the "normal" standard deviation (in the middle range) indicate normal development. Scores outside 1 Standard Deviation in either direction indicate abnormal development. | baseline, 6 months, 12 months | |
Secondary | 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 | The pre-school version (18 mo - 5 years 12 months) measures Emotionally Reactive; Anxious/Depressed; Somatic Complaints; Withdrawn; Sleep Problems; Attention Problems; Aggressive Behavior; Depressive Problems; Anxiety Problems; Autism Spectrum Problems; Attention Deficit/Hyperactivity Problems; Oppositional Defiant Problems. The school-age version (6-18 years) measures Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule Breaking Behavior, Aggressive Behavior; Depressive Problems Anxiety Problems, Somatic Problems, Attention Deficit/Hyperactivity Problems, Oppositional Defiant Problems, Conduct Problems. In both versions, scores are converted to t-scores, including overall internalizing, externalizing, and total scale scores. T-scores above the cutoffs (>60 "borderline, > 65 "clinical") indicate worse functioning in that domain. | baseline, 6 months, 12 months | |
Secondary | Changes in removal from birth family as an indicator of child safety and permanency | Administrative data from the New Hampshire Division of Children, Youth, and Families. More frequently removals indicates worse safety and permanency. | baseline, 6 months, 12 months | |
Secondary | Changes in child placement duration, number of placement changes, type of placement, discharge status | Administrative data from the New Hampshire Division of Children, Youth, and Families indicating child permanency. Fewer placement changes, less time in placement, less restrictive placement (foster care vs. residential), and positive discharge status (reunification or adoption) indicate better permanency | baseline, 6 months, 12 months | |
Secondary | Changes in child protection screened in referrals, type of allegation, disposition of allegation | Administrative data from the New Hampshire Division of Children Youth and Families. Administrative data from New Hampshire Division of Children Youth and Families. Higher numbers of screened in referrals and founded allegations indicate worse child safety | baseline, 6 months, 12 months | |
Secondary | Changes in the Addiction Severity Index (ASI), a measure of addiction severity in parents/caregivers | Measures seven potential problem areas in substance-abusing patients: medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. Responses to questions indicate frequency of use to intoxication for alcohol and frequency of any use of illicit drugs as well as subjective distress and motivation to seek treatment. For both of these latter two items, responses range from 1-5 with higher numbers indicating more subjective distress and more motivation for treatment. | baseline, 6 months, 12 months | |
Secondary | Changes in the Trauma Symptom Checklist-40, a measure of traumatic stress symptoms in parents/caregivers | Measures parent traumatic stress symptoms. Scores range from 0-120. Higher scores indicate more symptoms. | baseline, 6 months, 12 months | |
Secondary | Substance use treatment episode information as an indicator of parent/caregiver engagement in substance use treatment | Administrative data using the New Hampshire Bureau of Drug and Alcohol Services Treatment Episode Data - captures dates, substance type, frequency, discharge date and reason for discharge. Length of treatment, frequency of treatment, and positive/successful reasons for discharge are indicative of better engagement. | baseline, 6 months, 12 months |
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