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临床试验/NCT00600470
NCT00600470已完成1 期

Collaborative Mental Health Services for Behavior Disorders in Primary Care

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 858 人开始时间: 2000年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
858
试验地点
2
主要终点
Vanderbilt Parent ADHD Rating Scale; Child Health and Illness Profile; Pediatric Quality of Life Inventory; Individualized Goal Attainment Rating

研究概览

简要总结

This study will evaluate the effectiveness of a doctor-office collaborative care approach in treating children with disruptive behavior problems in the pediatric primary care setting.

详细描述

Disruptive behavior problems (DBP) involve a behavioral tendency of children and adolescents to continually disregard basic social rules and the rights of others. Symptoms of DBP include problematic aggression, antisocial tendencies, serious defiance of rules, and temper tantrums. Children or adolescents with DBP display this type of behavior at school, home, or other social situations, often affecting family life, academic performance, and relations with others. The causes of DBP are believed to be both environmental and biological. Children most at risk for DBP are those who have low birth weight, attention deficit hyperactivity disorder (ADHD), or a history of abuse or neglect. Behavioral therapy that targets parent and child skills has shown to be the most effective treatment for DBP. This study will evaluate the effectiveness of a doctor-office collaborative care (DOCC) approach in treating children with DBP in the pediatric primary care setting. The study is a continuation and extension of the parent study, Services for Kids in Primary Care (SKIP).

Participants in this single blind study will be randomly assigned to one of two treatment groups: doctor-office collaborative care (DOCC) or treatment as usual (TAU). Treatment will take place at one of eight participating primary care practices, each randomly assigned to either DOCC or TAU. All participants will undergo an initial assessment that will include a clinical evaluation with the care manager and research questionnaires. The families participating in the practices assigned to DOCC will receive cognitive behavioral therapy (CBT), parent management training (PMT), and ADHD management training. Participants will also complete ongoing behavioral questionnaires. There will be on average 12 DOCC sessions, lasting between 30 and 90 minutes, held in the primary care office. The sessions will occur over a 3- to 6-month period. The families participating in the practices assigned to TAU will receive a full review of initial assessment findings and specific recommendations for services in the community that would meet the clinical needs of the child participant. The parent/guardian of the child will also be provided psychoeducational resources via Web sites, literature, or reference materials. Lastly, participants in TAU will receive a follow-up call between 2 and 4 weeks after the initial assessment to assist with finding community programs or additional resource identification. All participants in both groups will undergo follow-up assessments at Months 6, 12, 18, 24, and 30 after the initial assessment. Each assessment will last 2 to 3 hours and will include self-report and interview questionnaires.

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
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Score of 75% on externalizing scale of PSC-17: score less than or equal to 6
  • Parent/guardian is concerned about the child's mental health
  • At least one parent/guardian who resides with the child is willing to participate in services and has signed an informed consent giving permission for the child to participate

排除标准

  • Child is currently prescribed and taking any of the following medications: SSRI, neuroleptics, antidepressants.
  • Emergent psychiatric conditions that require additional treatments (e.g., eating disorder/anorexia nervosa, substance dependence, PTSD-active phase, OCD, PDD/Autism/Aspergers)
  • Child has current suicidal or homicidal ideation with intent and a plan
  • Participation in ongoing outpatient services and plans to continue

结局指标

主要结局

Vanderbilt Parent ADHD Rating Scale; Child Health and Illness Profile; Pediatric Quality of Life Inventory; Individualized Goal Attainment Rating

时间窗: Measured at baseline and at Months 6, 12, 18, 24, and 30

次要结局

  • Parenting Stress Index; Brief Symptom Inventory; Alabama Parenting Questionnaire; Services Assessment for Children and Adolescents(Measured at baseline and at Months 6, 12, 18, 24, and 30)

研究者

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

David Kolko

Professor of Psychiatry, Psychology, and Pediatrics

University of Pittsburgh

研究点 (2)

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