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临床试验/NCT02694939
NCT02694939已完成不适用

Effectiveness of MI Enhanced Behavior Therapy for Adolescents With ADHD

Florida International University2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2015年5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
278
试验地点
2
主要终点
Behavior Problems in School

研究概览

简要总结

The proposed study evaluates the effectiveness of a family-based psychosocial treatment program for teens with ADHD (Supporting Teens' Academic Needs Daily; STAND) developed to be delivered in community settings. STAND is BT enhanced by Motivational Interviewing (MI) that was developed (R34 MH092466) for teens with ADHD through a stakeholder informed process. STAND consists of ten 50-minute sessions delivered by therapists with community-typical levels of training and supervision. Across randomized controlled pilot (N=28; N=36) and efficacy trials (N=128), STAND demonstrates medium to large effects on ADHD and ODD symptoms and indices of academic and family impairment. In the proposed study, 300 adolescents with ADHD who present for treatment at one of four community mental health agencies in Miami-Dade County, FL will be randomly assigned to STAND or agency usual care (UC). Participating agency therapists also will be randomly assigned to deliver STAND or UC. STAND therapists will receive a comprehensive treatment manual, three-day training, and weekly supervision from a project psychologist. Participants will be screened by research staff in the community setting and enrolled on a rolling basis over 30 months. Participants will be assessed at baseline, post-treatment, and three-month follow-up. In line with RDoC, multi-method measures will be obtained for treatment outcome (family and academic impairment), treatment mediators (executive functioning, parent academic involvement, parent-teen communication, parent/adolescent motivation, ADHD symptoms), and moderators of effectiveness (patient, practitioner, service delivery, and organization characteristics). Additional consumer perspective (satisfaction, therapeutic alliance) and agency fit (therapist competence, treatment fidelity, need for additional treatment, attendance, therapist attitude toward treatment, cost effectiveness) measures will also be obtained to evaluate effectiveness. We will recruit an ethnically diverse sample (65% Hispanic, 19% African-American, 16% Non-Hispanic White) that is historically underrepresented in research, but ideal for evaluating therapy effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ADHD diagnosis
  • IQ of at least 70
  • Enrollment in sixth through twelfth grade

排除标准

  • history of autism spectrum disorder
  • not attending a Miami-Dade County Public School
  • a primary presenting problem other than ADHD, requiring immediate treatment of a different domain

结局指标

主要结局

Behavior Problems in School

时间窗: 7 months

Official Disciplinary Records from School District

Academic Problems

时间窗: 7 months

Adolescent Academic Problems Checklist

Parent Teen Conflict

时间窗: 7 months

Conflict Behavior Questionnaire, Video Interaction Tasks

ADHD Symptoms

时间窗: 7 months

Conners, ADHD Checklist

School Grades

时间窗: 7 months

GPA

次要结局

  • Executive Functioning(7 months)
  • Organization Skills(7 months)
  • Quality of Therapeutic Relationship between the therapist and the patient(7 months)
  • Satisfaction with Treatment(7 months)
  • Motivation(7 months)
  • Parent academic Involvement(7 months)
  • parent-teen communication(7 months)
  • parent readiness to change(7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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