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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 750
- 试验地点
- 4
- 主要终点
- Family Functioning: General Functioning
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Family Functioning: General Functioning
时间窗: baseline, 6 month, 12 months, 18 months
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.
Youth mental health: Child Behavior Checklist(CBCL/YSR), Total Problems
时间窗: baseline, 6 months, 12 months, 18 months
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.
Caregiver mental health: Total Problems
时间窗: baseline, 6 months, 12 months, 18 months
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.
Present Value of FCT compared to Out-of-Home Placement
时间窗: 4 years
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.
次要结局
- Family Functioning: Affective Responsiveness(baseline, 6 month, 12 months, 18 months)
- Family Functioning: Problem Solving(baseline, 6 month, 12 months, 18 months)
- Family Functioning: Behavior Control(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Withdrawn Behaviors(baseline, 6 month, 12 months, 18 months)
- Family Functioning: Communication(baseline, 6 month, 12 months, 18 months)
- Family Functioning: Roles(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: CBCL/YSR Internalizing Disorder(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Anxious/Depressed(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Generalized Anxiety Disorder(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Specific Phobia(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Separation Anxiety Disorder(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Adaptive Functioning Scales: Job(baseline, 6 month, 12 months, 18 months)
- Family Functioning: Affective Involvement(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Somatic complaints(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Attention Problems(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Social anxiety disorder(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Adaptive Functioning Scales: Friends(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Adaptive Functioning Scales: Family(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: CBCL/YSR Externalizing Disorder(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Aggressive behavior(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Adaptive Functioning Scales: Spouse/Partner(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Syndrome Scales: Anxious/Depressed(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Syndrome Scales: Withdrawn(baseline, 6 month, 12 months, 18 months)
- Youth mental/behavioral health: Somatic symptom disorder(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Adaptive Functioning Scales: Education(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Syndrome Scales: Somatic Complaints(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Syndrome Scales: Thought Problems(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Adaptive Functioning Scales: Personal Strengths(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Substance Use Scales: Tobacco(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Substance Use Scales: Drugs(baseline, 6 month, 12 months, 18 months)
- Economic Burden: Impact on Expenses(Baseline, 6 month, 12 month, 18 month)
- Economic Burden: Loss of Income(Baseline, 6 month, 12 month, 18 month)
- Caregiver mental/Behavioral health: Syndrome Scales: Attention Problems(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Syndrome Scales: Aggressive Behavior(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: DSM-oriented scales-Anxiety Problems(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Syndrome Scales: Rule Breaking Behavior(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Syndrome Scales: Intrusive(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Diagnostic and Statistical Manual of Mental Disorders(DSM)-oriented scales-Depressive Symptoms(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: DSM-oriented scales-Antisocial Personality Problems(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Substance Use Scales: Alcohol(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Internalizing(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Externalizing(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: DSM-oriented scales-Somatic Problems(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: DSM-oriented scales-Attention Deficit/Hyperactivity Problems(baseline, 6 month, 12 months, 18 months)
- Caregiver mental/Behavioral health: Substance Use Scales: mean substance use(baseline, 6 month, 12 months, 18 months)
- Economic Burden: Debts(Baseline, 6 month, 12 month, 18 month)
- Retained in grade(1 year, 2 years, 3 years, 4 years)
- Chronic Absenteeism(1 year, 2 years, 3 years, 4 years)
- Out of home placement(baseline, 6 months, 12 months, 18 months)
- Caregiver mental/Behavioral health: DSM-oriented scales-Avoidant Personality Problems(baseline, 6 month, 12 months, 18 months)
- Economic Burden: Associated Expenses(Baseline, 6 month, 12 month, 18 month)
- Juvenile complaint and/or criminal charges(baseline, 6 month, 12 months, 18 months, 2 years, 4 years)
- Dropping out of school(1 year, 2 years, 3 years, 4 years)
- Economic Burden: Impact on Paid Work(Baseline, 6 month, 12 month, 18 month)
- Reported to child protective services(baseline, 6 month, 12 months, 18 months, 2 years, 4 years)
- Entered Foster care(baseline, 6 month, 12 months, 18 months, 2 years, 4 years)