FCT Study: Reducing the Need for Out-of-Home Placements (2018-0568)

  • End date
    Jun 30, 2027
  • participants needed
  • sponsor
    Duke University
Updated on 6 April 2022


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.


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.

  1. 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.
  2. 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.
  3. 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.

Condition Behavior Problem, Mental Disorder, Emotional Problem
Treatment Family Centered Treatment, Level III Out of Home Placement, Level II or Level III Out of Home Placement
Clinical Study IdentifierNCT03641664
SponsorDuke University
Last Modified on6 April 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note