FCT Study: Reducing the Need for Out-of-Home Placements

NCT ID: NCT03641664

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2027-06-30

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.

Conditions

Behavior Problem; Mental Disorder; Emotional Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Treatment: Family Centered Treatment

Family is offered choice of FCT or Level III out-of-home placement

Group Type: EXPERIMENTAL

Family Centered Treatment

Intervention Type: BEHAVIORAL

Family Centered Treatment® (FCT) is a promising practice for providing home-based services to families at-risk for their children being removed from home.

Control: Level III Out of Home Placement

Family is offered Level III out-of-home placement

Group Type: ACTIVE_COMPARATOR

Level II or Level III Out of Home Placement

Intervention Type: BEHAVIORAL

Residential care for children with emotional, behavioral, and/or mental health in North Carolina who have experienced a level of dysfunction that makes it impossible to function at an age appropriate level in their own homes or in a lower level of care. These services can be provided in a variety of locations from urban to rural, from facility based to community based and from public sector to private sector. This service provides a structured and supervised environment for the acquisition of skills necessary to enable the child to improve level of functioning to achieve and/or to maintain the most realistic level of independent function where earlier treatment gains are somewhat fragile and the child is subject to regression.

Interventions

Family Centered Treatment

Family Centered Treatment® (FCT) is a promising practice for providing home-based services to families at-risk for their children being removed from home.

Intervention Type: BEHAVIORAL

Level II or Level III Out of Home Placement

Residential care for children with emotional, behavioral, and/or mental health in North Carolina who have experienced a level of dysfunction that makes it impossible to function at an age appropriate level in their own homes or in a lower level of care. These services can be provided in a variety of locations from urban to rural, from facility based to community based and from public sector to private sector. This service provides a structured and supervised environment for the acquisition of skills necessary to enable the child to improve level of functioning to achieve and/or to maintain the most realistic level of independent function where earlier treatment gains are somewhat fragile and the child is subject to regression.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cardinal Innovations Health Care

Charlotte, North Carolina, United States

Partners Behavioral Health Management

Elkin, North Carolina, United States

Countries

United States

Other Identifiers

2018-0568

Identifier Type: -

Identifier Source: org_study_id