Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 4
- 主要终点
- Brief Problem Checklist (BPC, parent and child forms)
研究概览
简要总结
The Clinic Treatment Project tested two alternative methods of delivering evidence-based practices within public community-based mental health clinics, using training and supervision procedures designed for the settings and users.
详细描述
The Clinic Treatment Project focused on ethnically diverse youths aged 7-13 who were referred to community-based mental health clinics for problems involving disruptive behaviors, depression, anxiety, and any combination of these. Using a randomized block design, therapists were randomly assigned to deliver usual treatment procedures (usual care, or UC) in their clinics or evidence-based practices deployed in two forms: (a) standard manual treatment (SMT), using full treatment manuals, one at a time, exactly as they have been tested in clinical trials, and (b) modular manual treatment (MMT) in which therapists learn the component practices of the standard manuals but individualize the use of the components for each child using a guiding clinical algorithm. Unlike the SMT approach, the MMT approach allows the duration and sequencing of techniques to be individualized in an effort to fit the child's needs and allows the clinician to draw techniques from outside the target disorder domain when needed (e.g., to address noncompliance during the course of treating depression). Both SMT and MMT were supported by training and supervision procedures designed to fit providers and their clinic contexts. Assessments were carried out at pre-treatment, at post-treatment, and at 3-, 6-, 9-, 12-, 18-, and 24-month follow-ups. Assessments carried out at pre-treatment included(a) individual youth problems and disorders; (b) individual youth functioning at home and school; and (c) clinic staff beliefs and attitudes toward their work and workplace. Assessments carried out at post-treatment and follow-up only included measures of (a) youth, parent, and therapist satisfaction with treatment; (b) youth, parent and therapist views on the quality of the therapeutic relationship; and (c) treatment costs. Assessments carried out at follow-up only included (a) parent reports of any mental health service use following project treatment, and (b) therapist reports on the extent to which the treatment procedures they used in the project are continued after project termination. Analyses will address critical questions about deployment of evidence-based youth practices to clinical care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7 - 13 year olds and their parents
- •seeking services at community mental health clinics
- •primary problem or disorder related to anxiety, depression, or conduct problems
排除标准
- •Child is younger than 7 years, 9 months or older than 13 on the day of the phone screen.
- •Child has attempted suicide within the past year.
- •Schizophrenic spectrum diagnosis (including MDD w/ psychotic features)
- •Autism or another Pervasive Developmental Disorder (e.g., PDD NOS, Asperger's Disorder, Child Disintegrative Disorder, Rett's Disorder).
- •Anorexia Nervosa
- •Bulimia Nervosa
- •Mental Retardation
- •No relevant T-scores validate target disorders.
- •ADHD identified as primary reason for seeking treatment at phone screen
- •Child's sibling already included
- •Child's medication has not been regulated for one month or longer
结局指标
主要结局
Brief Problem Checklist (BPC, parent and child forms)
时间窗: Change over time from Day 1 to Day 267
Youth and parents were contacted weekly to report changes in youth functioning. Each person was asked to rate their own or their child's behavior on 12 items (6 internalizing and 6 externalizing behaviors) that were adapted from the Youth Self Report and the Child Behavior Checklist. Children and caregivers completed the pre-treatment assessment on Day 1, every week during treatment, and at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment.
次要结局
- Revised Children's Anxiety and Depression Scale(Change over time from Day 1 to Day 267)
- Brief Impairment Scale(Change over time from Day 1 to Day 712 (24-mo follow-up))
- Child Behavior Checklist (CBCL)(Change over time from Day 1 to Day 712 (24-mo follow-up))
- The Children's Interview for Psychiatric Syndromes-Child and Parent Forms (ChIPS/P-ChIPS)(Change over time from Day 1 to Day 267)
- Top Problems Assessment(Change over time from Day 1 to Day 712 (24-mo follow-up))
- Youth Self-Report Form (YSR)(Change over time from Day 1 to Day 712 (24-mo follow-up))
- Therapeutic Alliance Scale for Children(post-treatment (Day 267))
- Service Assessment for Children and Adolescents: Treatment and Auxiliary Service Use Scales(Change over time from Day 1 to Day 712 (24-mo follow-up))
- Brief Symptom Inventory(Change over time from Day 1 to Day 267)
- Services for Children & Adolescents - Parent Interview (SCAPI)(Change over time from Day 1 to Day 712 (24-mo follow-up))