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临床试验/NCT00834821
NCT00834821已完成不适用

Integrated Multi-setting Psychosocial Treatment for ADHD-Inattentive Type

University of California, San Francisco4 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2008年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
199
试验地点
4
主要终点
Inattention symptoms, as defined by the DSM-IV

研究概览

简要总结

This study will test the effectiveness of a new behavioral treatment, called the Child Life and Attention Skills Program, for children with attention deficit hyperactivity disorder, inattentive type.

详细描述

Attention deficit hyperactivity disorder (ADHD) is a common childhood disorder in which problems with focusing disrupt a normal life. There are two subtypes of ADHD: combined type (ADHD-C), which includes symptoms of inattention and hyperactivity or impulsivity, and inattentive type (ADHD-I), in which symptoms are limited to inattention. The profile of ADHD-I, including attention deficits, comorbid disorders, social impairments, and neurocognitive functioning, is sufficiently different from the profile of ADHD-C that treatments effective for ADHD-C may not also be effective in treating ADHD-I. Most studies of ADHD treatment evaluate ADHD-C, and there is very little research into treatments aimed specifically at ADHD-I. The Child Life and Attention Skills (CLAS) Program is a behavioral program designed specifically for ADHD-I and combines life skills training for the child, teacher consultation, and parent training techniques adapted from ADHD-C treatments. This study will compare the effectiveness of the CLAS Program, standard parent training, and community referrals in treating children with ADHD-I.

Participation in this study will last 11 to 12 weeks, followed by a 5- to 7-month follow-up period. On the basis of parent and teacher evaluations of each child's behavior, invitations to participate in screening procedures for the study will be extended to children and their parents. There will be two screening visits, during which the child will undergo reviews of medical and developmental history, diagnostic interviews, intelligence testing, academic achievement testing, and neuropsychological testing. The child and parent will be videotaped in a series of interactions, and both will complete questionnaires about child functioning, parent functioning, family functioning, and family relations. The child's teacher and school principal will also be contacted to ensure that they are willing to participate in the study.

Eligible participants will then be randomly assigned to receive the CLAS Program, parent-focused training (PFT), or community referrals. The CLAS Program will involve a half-hour orientation and up to five half-hour weekly meetings with the child's teacher, therapist, and parent over 11 to 12 weeks. The program will also involve ten 1.5-hour group sessions for parents, with separate group sessions for children at the same time, and up to five individual family sessions led by a therapist. Teachers will participate in a school-home note system for maintaining and rewarding child behavior; parents will be taught strategies for giving commands, using rewards and consequences, and establishing routines and organizational schemes; and children will be taught social interaction skills, homework skills, and organizational skills.

Participants in the PFT group will attend the ten 1.5-hour parent group sessions and up to five individual family sessions. Participants in the community referrals group will only receive referrals to community mental health practitioners.

All participants will undergo assessments that are similar to those in the screening visit after completing treatment and again at a follow-up visit 5 to 7 months later. Participants in the CLAS and PFT groups will continue monthly individual family sessions with a therapist until undergoing the follow-up assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Primary DSM-IV diagnosis of attention deficit hyperactivity disorder, inattentive type (ADHD-I)
  • IQ score greater than 80
  • Living with one biological or adoptive parent for the past year
  • Currently attending school full time
  • Consent of school to participate in the study

排除标准

  • Current use of nonstimulant psychoactive medication
  • Severe visual or hearing impairment
  • Severe language delay
  • Major neurological illness
  • Diagnosis of one of the following: psychosis, bipolar disorder, obsessive-compulsive disorder, pervasive developmental disorder, clinical depression, or suicidality
  • Enrolled in all-day special education
  • Parent or child does not speak English
  • Child or family is currently involved in and expects to continue psychotherapy to address child's attention, behavioral, or emotional problems

研究组 & 干预措施

1

Experimental

Participants will undergo the Child Life and Attention Skills (CLAS) Program.

干预措施: Child Life and Attention Skills (CLAS) Program (Behavioral)

2

Active Comparator

Participants will undergo parent focused training (PFT).

干预措施: Parent Focused Training (PFT) (Behavioral)

3

No Intervention

Participants will receive a list of referrals for clinical services as needed, including professional organizations, support groups, and the community mental health system.

结局指标

主要结局

Inattention symptoms, as defined by the DSM-IV

时间窗: Measured immediately post-treatment and at a follow-up 5 to 7 months later

次要结局

  • Academic and social functioning(Measured immediately post-treatment and at a follow-up 5 to 7 months later)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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