AzTrials
AzTrials

Behavior Problem2018-0568NCT03641664

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

A study testing Family Centered Treatment and Level II or Level III Out of Home Placement in people with Behavior Problem and Mental Disorder, run by Duke University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 to 17 years
What is being tested?
Family Centered Treatment and Level II or Level III Out of Home Placement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
2 sitesUnited States
Study dates
10 Sep 2018to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cardinal Innovations Health Care

    Charlotte, North Carolina, 28262

  • Partners Behavioral Health Management

    Elkin, North Carolina, 28612

Other trials in United States

About this study

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

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.
Read the 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.

  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.

Being tested
Family Centered Treatment, Level II or Level III Out of Home Placement
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Centered TreatmentBehavioural

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

  • Level II or Level III Out of Home PlacementBehavioural

    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.

Study groups in NCT03641664
Study groupRoleWhat they receive
Treatment: Family Centered TreatmentExperimentalFamily is offered choice of FCT or Level III out-of-home placement
Receives: Behavioral: Family Centered Treatment
Control: Level III Out of Home PlacementActive comparatorFamily is offered Level III out-of-home placement
Receives: Behavioral: Level II or Level III Out of Home Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 6 month, 12 months, 18 months

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: baseline, 6 months, 12 months, 18 months

  4. 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.

    Measured: baseline, 6 months, 12 months, 18 months

  5. 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.

    Measured: 2 years

  6. 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.

    Measured: 3 years

  7. 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.

    Measured: 4 years

Secondary outcomes (56)

  1. Family Functioning: Communication

    The Family Assessment Device will be used to measure how information is exchanged within a family (Communication Subscale). This subscale ranges from 1 to 4. Higher scores indicate a worse outcome. Both overall functioning and change in functioning will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  2. Family Functioning: Affective Responsiveness

    The Family Assessment Device will be used to measure the ability of the family to respond to a range of stimuli with the appropriate quality and quantity of feelings. This subscale ranges from 1 to 4. Higher scores indicate a worse outcome. Both overall functioning and change in functioning will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  3. Family Functioning: Problem Solving

    The Family Assessment Device will be used to measure the family's ability to resolve problems at a level that maintains 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.

    Measured: baseline, 6 month, 12 months, 18 months

  4. Family Functioning: Roles

    The Family Assessment Device will be used to measure recurrent patterns of behavior by which individuals fulfill family functions. This subscale ranges from 1 to 4. Higher scores indicate a worse outcome. Both overall functioning and change in functioning will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  5. Family Functioning: Behavior Control

    The Family Assessment Device will be used to measure the pattern a family adopts for handling behavior in three types of situations. First, there are physically dangerous situations where the family will have to monitor and control the behavior of its members. Second, there are situations which involve meeting and expressing psychobiological needs or drives such as eating, drinking, sleeping, eliminating, sex and aggression. Finally, there are situations involving interpersonal socializing behavior both among family members and with people outside the family. This subscale ranges from 1 to 4. Higher scores indicate a worse outcome. Both overall functioning and change in functioning will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  6. Family Functioning: Affective Involvement

    The Family Assessment Device will be used to measure the degree to which the family as a whole shows interest in and values the activities and interests of individual family members. This subscale ranges from 1 to 4. Higher scores indicate a worse outcome. Both overall functioning and change in functioning will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  7. Youth mental/behavioral health: CBCL/YSR Internalizing Disorder

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  8. Youth mental/behavioral health: CBCL/YSR Externalizing Disorder

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  9. Youth mental/behavioral health: Anxious/Depressed

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  10. Youth mental/behavioral health: Somatic complaints

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  11. Youth mental/behavioral health: Withdrawn Behaviors

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  12. Youth mental/behavioral health: Attention 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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  13. Youth mental/behavioral health: Aggressive behavior

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  14. Youth mental/behavioral health: Generalized Anxiety Disorder

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  15. Youth mental/behavioral health: Separation Anxiety Disorder

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  16. Youth mental/behavioral health: Specific Phobia

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  17. Youth mental/behavioral health: Social anxiety disorder

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  18. Youth mental/behavioral health: Somatic symptom disorder

    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)that measures a broad range of behavioral, emotional, and social behaviors. Respondents rate items (0 = "not true," 1 = "somewhat or sometimes true," 2 = "very true or often true") based on the past 6 months.

    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 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. Change in mental health and overall functioning at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months

  19. Caregiver mental/Behavioral health: Adaptive Functioning Scales: Friends

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  20. Caregiver mental/Behavioral health: Adaptive Functioning Scales: Spouse/Partner

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  21. Caregiver mental/Behavioral health: Adaptive Functioning Scales: Family

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  22. Caregiver mental/Behavioral health: Adaptive Functioning Scales: Job

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  23. Caregiver mental/Behavioral health: Adaptive Functioning Scales: Education

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  24. Caregiver mental/Behavioral health: Adaptive Functioning Scales: Personal Strengths

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  25. Caregiver mental/Behavioral health: Syndrome Scales: Anxious/Depressed

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  26. Caregiver mental/Behavioral health: Syndrome Scales: Withdrawn

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  27. Caregiver mental/Behavioral health: Syndrome Scales: Somatic Complaints

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  28. Caregiver mental/Behavioral health: Syndrome Scales: Thought 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.

    Measured: baseline, 6 month, 12 months, 18 months

  29. Caregiver mental/Behavioral health: Syndrome Scales: Attention 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.

    Measured: baseline, 6 month, 12 months, 18 months

  30. Caregiver mental/Behavioral health: Syndrome Scales: Aggressive Behavior

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  31. Caregiver mental/Behavioral health: Syndrome Scales: Rule Breaking Behavior

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  32. Caregiver mental/Behavioral health: Syndrome Scales: Intrusive

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  33. Caregiver mental/Behavioral health: Diagnostic and Statistical Manual of Mental Disorders(DSM)-oriented scales-Depressive Symptoms

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  34. Caregiver mental/Behavioral health: DSM-oriented scales-Anxiety 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.

    Measured: baseline, 6 month, 12 months, 18 months

  35. Caregiver mental/Behavioral health: DSM-oriented scales-Somatic 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.

    Measured: baseline, 6 month, 12 months, 18 months

  36. Caregiver mental/Behavioral health: DSM-oriented scales-Avoidant Personality 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.

    Measured: baseline, 6 month, 12 months, 18 months

  37. Caregiver mental/Behavioral health: DSM-oriented scales-Attention Deficit/Hyperactivity 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.

    Measured: baseline, 6 month, 12 months, 18 months

  38. Caregiver mental/Behavioral health: DSM-oriented scales-Antisocial Personality 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.

    Measured: baseline, 6 month, 12 months, 18 months

  39. Caregiver mental/Behavioral health: Substance Use Scales: Tobacco

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  40. Caregiver mental/Behavioral health: Substance Use Scales: Alcohol

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  41. Caregiver mental/Behavioral health: Substance Use Scales: Drugs

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  42. Caregiver mental/Behavioral health: Substance Use Scales: mean substance use

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  43. Caregiver mental/Behavioral health: Externalizing

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  44. Caregiver mental/Behavioral health: Internalizing

    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.

    Measured: baseline, 6 month, 12 months, 18 months

  45. Economic Burden: Associated Expenses

    The Child and Adolescent Impact Assessment (CAIA) measures the impact that a child or adolescent's symptoms have on the family. The respondent for the CAIA is the parent or caregiver. Respondents will be asked to describe any expenses associated with getting help for their child by responding "there have been no expenses," "there have been expenses, but they have been affordable," or "there have been expenses causing effects on other areas of family budget." A variable will be coded to indicate whether there have been associated expenses (0 = "no expenses," 1 = "expenses but affordable," 2 = "expenses causing effects on other areas of family budget"). Lower expenses are more desirable than higher expenses that are not affordable or effect the family budget.

    Measured: Baseline, 6 month, 12 month, 18 month

  46. Economic Burden: Impact on Expenses

    The Child and Adolescent Impact Assessment (CAIA) measures the impact that a child or adolescent's symptoms have on the family. The respondent for the CAIA is the parent or caregiver. A series of yes/no questions will ask whether the child's problems have had an impact on family budget for other things, are causing restrictions elsewhere, whether respondent has the savings to cover them, whether respondent has had to work extra hours, and whether the respondent or anyone else has had to take an additional job. A variable will be coded to indicate whether there has been an impact on savings (0 = "absent," 1 = "using savings," 2 = "necessitate cutting back on other expenditures," 3 = "necessitate working additional hours/jobs"). Less impact on family expenses and budget is more desirable than a greater impact.

    Measured: Baseline, 6 month, 12 month, 18 month

  47. Economic Burden: Debts

    The Child and Adolescent Impact Assessment (CAIA) measures the impact that a child or adolescent's symptoms have on the family. The respondent for the CAIA is the parent or caregiver. Respondents will be asked whether the child's problems have caused them to go into debt to cover expenses or whether they are concerned about being able to pay back expenses. A variable will be coded to indicate whether there are associated debts (0 = "absent," 2 = "incurred debts but envision no serious problems with payback," 3 = "incurred debts and envision will have problems with payback"). Less debt due to expenses is more desirable than incurring debt and having problems paying it back.

    Measured: Baseline, 6 month, 12 month, 18 month

  48. Economic Burden: Loss of Income

    The Child and Adolescent Impact Assessment (CAIA) measures the impact that a child or adolescent's symptoms have on the family. The respondent for the CAIA is the parent or caregiver. Respondent will be asked whether child's problems have affected family's income. A variable will be coded to indicate whether there has been a loss of income (0 = "absent," 1 = "present"). No loss of income is preferable to any loss of income.

    Measured: Baseline, 6 month, 12 month, 18 month

  49. Economic Burden: Impact on Paid Work

    The Child and Adolescent Impact Assessment (CAIA) measures the impact that a child or adolescent's symptoms have on the family. The respondent for the CAIA is the parent or caregiver. A series of yes/no questions will be asked to indicate whether child's problems have affected paid work, whether they have lost any time at work, or had to cut down to part-time work, or been unable to work at all, or lost their job. This same series of questions will be asked in relation to both parents and other family members, as applicable. A variable will be coded to indicate whether there has been a loss of income or impact on paid work (0 = "no income lost," 2 = "time lost at work, or hours reduced," 3 = "unable to work or lost job"). No loss of income is preferable to reduced hours or unable to work.

    Measured: Baseline, 6 month, 12 month, 18 month

  50. Reported to child protective services

    Social service records will be obtained to indicated whether or not a child was referred to child protective services (CPS). This will be scored as yes=1 and no=0 (i.e., range from 0 to 1). Higher values indicate a worse outcome. Both any CPS involvement and repeat use of CPS involvement will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months, 2 years, 4 years

  51. Entered Foster care

    Social service records will be obtained to indicated whether or not a child entered or re-entered foster care. This will be scored as yes=1 and no=0 (i.e., range from 0 to 1). Higher values indicate a worse outcome. Any entry into foster care care at various time points will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months, 2 years, 4 years

  52. Juvenile complaint and/or criminal charges

    Whether or not a child was criminally involved will be measured by presence of a juvenile justice complaint and/or adult criminal charge. This information will be obtained through administrative records on juvenile justice, court records and/or corrections records. The range of this will be 0 =no juvenile/criminal record and 1=criminal/juvenile record. Higher scores indicate a worse outcome. A count of the total number of days in which a participant had a juvenile complaint and/or adult charge will also be calculated. Higher scores indicate a worse outcome. Any delinquent or criminal complaints at the various timepoints will be assessed.

    Measured: baseline, 6 month, 12 months, 18 months, 2 years, 4 years

  53. Retained in grade

    Education records will be used to indicate whether or not an individual repeated a grade in school. This will be scored as 1=retained 0=not retained. Higher values indicate worse outcomes. Any grade retention at the various timepoints will be assessed.

    Measured: 1 year, 2 years, 3 years, 4 years

  54. Chronic Absenteeism

    Education records will be used to measure whether or not a student was chronically absent from school which will be measured as missed more than 15 days of school (=1) or missed 15 days or fewer days from school. This will be scored as 1=was chronically absent 0=was not chronically absent with higher values indicating a worse outcome. Any chronic absenteeism behavior at the various timepoints will be assessed.

    Measured: 1 year, 2 years, 3 years, 4 years

  55. Dropping out of school

    Education records will be used to measure whether or not a student dropped out from school (=1). This will be scored as 1=drop out 0=graduated or still in school. Higher values indicate a worse outcome. Whether or not the child has dropped out of school at the various timepoints will be assessed.

    Measured: 1 year, 2 years, 3 years, 4 years

  56. Out of home placement

    The Service Assessment for Children \& Adolescents (SACA) will be used to ascertain caregiver reports of whether or not a child had an out of home place for behavioral or emotional or drug or alcohol problems. A series of yes/no questions will ask if their child has stayed overnight in a hospital, treatment center, group or foster home, juvenile justice facility, detention center/prison or jail, or emergency shelter for behavioral, emotional, or drug or alcohol problems. A variable will be created to indicate whether or not the individual was placed out of home (1=yes, 0=0). Higher values indicate worse outcomes. Whether or not the child was placed out of home at the various timepoints will be assessed.

    Measured: baseline, 6 months, 12 months, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start10 Sep 2018
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03641664
Sponsor's protocol ID
2018-0568
Acronym
2018-0568
Status last verified
Feb 2025
First submitted
23 Jul 2018
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Family Centered Treatment and Level II or Level III Out of Home Placement in people with Behavior Problem and Mental Disorder, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Family Functioning: General Functioning (time frame: baseline, 6 month, 12 months, 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03641664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.

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