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

NCT03641664 | Active Not Recruiting

• 1 other identifier: 2018-0568
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 2

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.

Conditions

Behavior Problem; Mental Disorder; Emotional Problem

Outcome Measures

Primary Outcomes (7)

• Family Functioning: General Functioning

  The Family Assessment Device will be used to measure overall level of family functioning. This subscale ranges from 1 to 4. Higher scores indicate a worse outcome. Both overall functioning and change in functioning will be assessed.

  baseline, 6 month, 12 months, 18 months

• Present Value of FCT compared to Out-of-Home Placement

  A cost-benefit analysis will be conducted by calculating the present value in dollars of FCT versus the present value in dollars of out-of-home placement. Behavioral and physical health costs will be measured using claims and encounter data. Higher costs are less desirable than lower costs.

  1 year

• Youth mental health: Child Behavior Checklist(CBCL/YSR), Total Problems

  The Child Child Behavior Checklist (CBCL)/ Adult Behavior Check List (ABCL)/Youth Self Report (YSR)/Adult Self Report (ASR) are part of The Achenbach System of Empirically Based Assessment (ASEBA) and measures behavioral, emotional, and social behaviors. Respondents rate problem items during the past 6 months as 0 for "not true," 1 for "somewhat or sometimes true," and 2 for "very true or often true". The respondent for the CBCL/ABCL is a caregiver. The CBCL is for youth aged 6-18 and the ABCL is for individuals aged 18-59. The respondent for the YSR/ASR are the youth/young adult reporting on him/herself. The CBCL has 113 items, the YSR has 112 items, and the ABCL is 123 items. The raw scores are compared with age- and gender-matched controls from a standardization sample; standard scores are derived (mean = 50, standard deviation = 10). Worst score is 80; best score is 30. Change in mental health and overall mental health functioning at the various timepoints will be assessed.

  baseline, 6 months, 12 months, 18 months

• Caregiver mental health: Total Problems

  The Adult Self Report (ASR) is part of The Achenbach System of Empirically Based Assessment (ASEBA) that measures a broad range of behavioral, emotional, and social behaviors. The ABC is administered in interview format and respondents are asked to rate problem items as 0 for "not true," 1 for "somewhat or sometimes true," and 2 for "very true or often true", based on the past six months. The respondent for the ASR is the adult (self). The ASR consists of 126 items. The raw scores from the items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30. Both change in mental health and overall mental health functioning at the various timepoints will be assessed.

  baseline, 6 months, 12 months, 18 months

• Present Value of FCT compared to Out-of-Home Placement

  A cost-benefit analysis will be conducted by calculating the present value in dollars of FCT versus the present value in dollars of out-of-home placement. Behavioral and physical health costs will be measured using claims and encounter data. Higher costs are less desirable than lower costs.

  2 years

• Present Value of FCT compared to Out-of-Home Placement

  A cost-benefit analysis will be conducted by calculating the present value in dollars of FCT versus the present value in dollars of out-of-home placement. Behavioral and physical health costs will be measured using claims and encounter data. Higher costs are less desirable than lower costs.

  3 years

• Present Value of FCT compared to Out-of-Home Placement

  A cost-benefit analysis will be conducted by calculating the present value in dollars of FCT versus the present value in dollars of out-of-home placement. Behavioral and physical health costs will be measured using claims and encounter data. Higher costs are less desirable than lower costs.

  4 years

Secondary Outcomes (56)

• Family Functioning: Communication

  baseline, 6 month, 12 months, 18 months

• Family Functioning: Affective Responsiveness

  baseline, 6 month, 12 months, 18 months

• Family Functioning: Problem Solving

  baseline, 6 month, 12 months, 18 months

• Family Functioning: Roles

  baseline, 6 month, 12 months, 18 months

• Family Functioning: Behavior Control

  baseline, 6 month, 12 months, 18 months

Study Arms (2)

Treatment: Family Centered Treatment

EXPERIMENTAL

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

Behavioral: Family Centered Treatment

Control: Level III Out of Home Placement

ACTIVE COMPARATOR

Family is offered Level III out-of-home placement

Behavioral: Level II or Level III Out of Home Placement

Interventions

Family Centered Treatment 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.

Treatment: Family Centered Treatment

Level II or Level III Out of Home Placement 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.

Control: Level III Out of Home Placement

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Cardinal Innovations Health Care

Charlotte, North Carolina, 28262, United States

Location

Partners Behavioral Health Management

Elkin, North Carolina, 28612, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 22, 2018
• Study Start: September 10, 2018
• Primary Completion: June 30, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

US (2)