Clinical trial NCT03641664: FCT Study: Reducing the Need for Out-of-Home Placements
Official title: Reducing the Need for Out-of-Home Placements: A Randomized Controlled Trial to Examine the Effects of Family Centered Treatment on Well-Being Outcomes and Public Dollar Costs
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Behavior Problem
Mental Disorder
Emotional Problem
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 750
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Does Family Centered Treatment (FCT) result in better youth, family, and cost outcomes, as compared to a Level II or Level III out-of-home placement (OHP)?

The investigators test the hypotheses that among children/youth authorized to a Level II or Level III out-of-home placement, relative to youth who receive such a placement, those who receive FCT will have:

* Better: family functioning and mental/behavioral health outcomes (youth and caregiver).
* Lower probability of: being subject of a child protective services report, entering (or re-entering) foster care, being arrested, being retained in grade, being chronically absent (missing \>15 days), dropping out of high school, or receiving an out-of-home placement.
* Lower cost of care.

Detailed description: The goal of this study is to examine the effectiveness of FCT on a number of youth, family, and cost outcomes, as compared to a Level II or Level III out-of-home placement.

Children who are appropriate for Level III service may exhibit the following behaviors:

* Inability to follow directions and conform to structure of school, home or community
* Constant, sometimes violent arguments with caretakers, peers, siblings and/or teachers
* Moderate level of self-injurious behavior, risk taking, sexual promiscuity
* Suicidal actions/history of serious suicidal actions
* Almost daily physical altercations in school, home or community
* Constant verbally aggressive and provocative language
* Frequent and severe property damage
* Probable involvement with the legal system
* Frequent school suspensions
* Moderate to high risk for sexually victimizing others

Typically, children approved for such services are in need of:

* A higher level of supervision and structure than can be provided in a Level II facility;
* Supervision by awake staff during times when the child is sleeping in order to maintain the child;
* A facility that is "staff secure" (i.e., there are no locks, but the child needs a high level of constant supervision to be maintained in the community; and
* Child is only minimally accepting of treatment.

Overall, this service is responsive to the need for intensive, active, therapeutic intervention, which requires a staff secure treatment setting in order to be successfully implemented. This setting has a higher level of consultative and direct service from psychiatrists, psychologists, therapists, medical professionals, etc.

Residential Treatment Level II Service provides a moderate to highly structured and supervised environment. This level of service is responsive to the need for intensive, interactive, therapeutic interventions, which still fall below the level of staff secure/24-hour supervision or secure treatment settings. The staffing structure may include family and program type settings.

A. Program Type The staff is not necessarily awake during sleep time, but must be constantly available to respond to a beneficiary's needs, while beneficiaries are involved in educational, vocational, social or other activities, except for periods of planned respite.

B. Family Type The provider is not necessarily awake during sleep time but must be constantly available to respond to a beneficiary's needs, while beneficiaries are involved in educational, vocational, social or other activities, except for periods of planned respite.

C. Program Type and Family Type Activities

This service in the family or program settings includes the following activities:

1. Individualized and intensive supervision and structure of daily living designed to minimize the occurrence of behaviors related to functional deficits to ensure safety during the presentation of out-of-control behaviors or to maintain an optimum level of functioning.
2. Specific and individualized psychoeducational and therapeutic interventions (e.g., anger management, social skills, family living skills, crisis intervention, etc.)
3. Direct and active intervention in assisting beneficiaries in the process of being involved in and maintaining in naturally occurring community support systems and supporting the development of personal resources (assets, protective factors, etc).

Approximately 750 children/youth will be randomized into one of the two treatments after a Managed Care Organization (MCO) has authorized the OHP request. Birthdays will serve as the method by which children/youth are randomized (e.g., children born on an even numbered day would be randomized into FCT, and children born on an odd numbered day would be randomized into the OHP they were just authorized for). This randomization would occur at the MCO-level, within the Utilization Management division (UM).

Duke-Center for Child \& Family Policy (CCFP) staff will approach those families randomized into the OHP (i.e., control group) to participate in the study within a month of the authorization. CCFP and the MCOs will enter into a Business Associate's Agreement (BAA) that will provide CCFP with identified information in order to approach the OHP providers and families about the study.

For those children/youth randomized to receive FCT, MCOs and CCFP staff will work in tandem to notify FCT providers of these potential patients. FCT providers will then approach families about participating in FCT rather than the OHP. They would also recruit the families to participate in the research study, regardless of whether or not the family chooses to participate in FCT. The study would utilize an intent-to-treat design, whereby all families assigned to receive FCT, regardless of whether or not they actually receive the service, will be considered as the "treatment" group in analyses.

Eligibility criteria: Inclusion Criteria:

* Participant has been authorized for a level II or level III Out of Home Placement by North Carolina (NC) Division of Medical Assistance
* Youth must have a caregiver and home environment with which to implement FCT,
* Youth must live within a county in NC where FCT service providers implement FCT.

Exclusion Criteria:

* if a youth is currently working with an in-home mental health service provider when the authorization for a Level II or Level III OHP is submitted, that provider cannot be a FCT provider for inclusion into the study
* youth with diagnosed developmental delays or other cognitive impairments will be excluded into the randomization process and recruitment into the longitudinal study.
* Youth for whom the MCO knows that there are current safety concerns which makes them unable to remain in the home with their parent/guardian

Primary outcomes:
measure: Family Functioning: General Functioning
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Present Value of FCT compared to Out-of-Home Placement
timeFrame: 1 year
measure: Youth mental health: Child Behavior Checklist(CBCL/YSR), Total Problems
timeFrame: baseline, 6 months, 12 months, 18 months
measure: Caregiver mental health: Total Problems
timeFrame: baseline, 6 months, 12 months, 18 months
measure: Present Value of FCT compared to Out-of-Home Placement
timeFrame: 2 years
measure: Present Value of FCT compared to Out-of-Home Placement
timeFrame: 3 years
measure: Present Value of FCT compared to Out-of-Home Placement
timeFrame: 4 years
Secondary outcomes:
measure: Family Functioning: Communication
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Family Functioning: Affective Responsiveness
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Family Functioning: Problem Solving
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Family Functioning: Roles
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Family Functioning: Behavior Control
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Family Functioning: Affective Involvement
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: CBCL/YSR Internalizing Disorder
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: CBCL/YSR Externalizing Disorder
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Anxious/Depressed
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Somatic complaints
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Withdrawn Behaviors
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Attention Problems
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Aggressive behavior
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Generalized Anxiety Disorder
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Separation Anxiety Disorder
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Specific Phobia
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Social anxiety disorder
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Youth mental/behavioral health: Somatic symptom disorder
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Adaptive Functioning Scales: Friends
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Adaptive Functioning Scales: Spouse/Partner
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Adaptive Functioning Scales: Family
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Adaptive Functioning Scales: Job
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Adaptive Functioning Scales: Education
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Adaptive Functioning Scales: Personal Strengths
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Syndrome Scales: Anxious/Depressed
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Syndrome Scales: Withdrawn
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Syndrome Scales: Somatic Complaints
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Syndrome Scales: Thought Problems
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Syndrome Scales: Attention Problems
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Syndrome Scales: Aggressive Behavior
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Syndrome Scales: Rule Breaking Behavior
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Syndrome Scales: Intrusive
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Diagnostic and Statistical Manual of Mental Disorders(DSM)-oriented scales-Depressive Symptoms
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: DSM-oriented scales-Anxiety Problems
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: DSM-oriented scales-Somatic Problems
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: DSM-oriented scales-Avoidant Personality Problems
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: DSM-oriented scales-Attention Deficit/Hyperactivity Problems
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: DSM-oriented scales-Antisocial Personality Problems
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Substance Use Scales: Tobacco
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Substance Use Scales: Alcohol
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Substance Use Scales: Drugs
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Substance Use Scales: mean substance use
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Externalizing
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Caregiver mental/Behavioral health: Internalizing
timeFrame: baseline, 6 month, 12 months, 18 months
measure: Economic Burden: Associated Expenses
timeFrame: Baseline, 6 month, 12 month, 18 month
measure: Economic Burden: Impact on Expenses
timeFrame: Baseline, 6 month, 12 month, 18 month
measure: Economic Burden: Debts
timeFrame: Baseline, 6 month, 12 month, 18 month
measure: Economic Burden: Loss of Income
timeFrame: Baseline, 6 month, 12 month, 18 month
measure: Economic Burden: Impact on Paid Work
timeFrame: Baseline, 6 month, 12 month, 18 month
measure: Reported to child protective services
timeFrame: baseline, 6 month, 12 months, 18 months, 2 years, 4 years
measure: Entered Foster care
timeFrame: baseline, 6 month, 12 months, 18 months, 2 years, 4 years
measure: Juvenile complaint and/or criminal charges
timeFrame: baseline, 6 month, 12 months, 18 months, 2 years, 4 years
measure: Retained in grade
timeFrame: 1 year, 2 years, 3 years, 4 years
measure: Chronic Absenteeism
timeFrame: 1 year, 2 years, 3 years, 4 years
measure: Dropping out of school
timeFrame: 1 year, 2 years, 3 years, 4 years
measure: Out of home placement
timeFrame: baseline, 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Cardinal Innovations Health Care
state: North Carolina
city: Elkin
country: United States
facility: Partners Behavioral Health Management
state: North Carolina
Study officials:
References: