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临床试验/NCT02229305
NCT02229305已完成不适用

Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project in Maine - Phase III

Harvard University2 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
235
试验地点
2
主要终点
Brief Problem Checklist (BPC, parent and child forms)

研究概览

简要总结

This study focused on youths who were referred to community-based mental healths clinics for problems related to disruptive behaviors, depression, anxiety, traumatic stress, and any combination of these problems. Therapists were randomly assigned to deliver usual treatment procedures (usual care, or UC) in their clinics or an evidence-based, modularized treatment (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems, or MATCH-ADTC). Assessments were conducted at pre-treatment and post-treatment, and every 3 to 6 months for two years. Results will address critical questions about deployment of evidence-based youth practices to clinical settings.

详细描述

This study focused on youths aged 6 - 15 who were referred to community-based mental healths clinics for problems related to disruptive behaviors, depression, anxiety, traumatic stress, and any combination of these problems. Using a randomized block design, therapists were randomly assigned to deliver usual treatment procedures (usual care, or UC) in their clinics or an evidence-based, modularized treatment (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems, or MATCH-ADTC). MATCH-ADTC was 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 evidence-based treatments. Assessments carried out at post-treatment and follow-ups included measures of (1) youth, caregiver, and therapist satisfaction with treatment; (b) youth, caregiver, and therapist views on the quality of the therapeutic relationship; and (c) treatment costs. Assessments carried out at follow-up only included measures of (a) caregiver reports of any mental health service use following project treatment; (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 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
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 6 - 15 year old and their caregivers
  • seeking services at community mental health clinics
  • primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems

排除标准

  • Child is younger than 6 years or older than 15 years on the day of the phone screen
  • Child has attempted suicide within the past year
  • Schizophrenic spectrum disorders (including MDD with psychotic features)
  • Autism or another Pervasive Developmental Disorder (E.g., PDD NOS, Asperger's Disorder, Child Disintegration 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 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 242 (end of treatment)

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 242days (SD = 121 days) after the pre-treatment assessment.

Top Problems Assessment

时间窗: Change over time from Day 1 to Day 735 (24-month follow-up)

Youths and parents were asked to identify "The three most important problems for which you need \[or "your child needs"\] help." at the intake assessment. The six resulting problems (3 from youth, 3 from parent) were then rated on a scale of 0 ("Not serious at all") to 10 ("Very serious problem") by youth and parent. Youths and parents completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 242 days (SD = 121 days) after the pre-treatment assessment, and at 3-, 6-, 9-, 12- and 24-month follow-up from Day 1. (Used as a measure of clinical outcome.)

次要结局

  • UCLA PTSD Index(Change over time from Day 1 to Day 735 (24-month follow-up))
  • Youth Self Report (YSR)(Change over time from Day 1 to Day 735 (24-month follow-up))
  • Child Behavior Checklist(Change over time from Day 1 to Day 735 (24-month 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 tiem from Day 1 to Day 735 (24-month follow-up))
  • Brief Impairment Scale(Change over time from Day 1 to Day 735 (24-month follow-up))
  • Services for Children and Adolescents - Parent Interview (SCAPI)(Change over time from Day 1 to Day 735 (24-month follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Weisz

Primary Investigator

Harvard University

研究点 (2)

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