Group Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: a Randomized Multicenter Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Post-treatment ADHD symptoms
研究概览
简要总结
This is the first randomized controlled study that tests the efficacy of a cognitive-behavioral group therapy (CBT) on adolescents with ADHD who were in pharmacological treatment but still presented persistent symptoms.
详细描述
A multicenter, randomized rater-blinded controlled trial was carried out in a sample of 119 adolescents (15-21 years) and was conducted between April 2012- May 2014. Patients were randomly assigned to 12 group manualized cognitive-behavioural group therapy sessions (n=45) or a waiting list control group (N=44). Primary outcomes were assessed by a blind evaluator (ADHD Rating Scale, Clinical Global Impression Scale for Severity, Global Assessment Functioning) before and after treatment as well as by self-report and parent informant ratings.
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 (Investigator)
入排标准
- 年龄范围
- 15 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV ADHD diagnosis
- •age between 15 and 21 years
- •stabilized doses of medication for ADHD for at least 2 months prior to the study
- •agreement not to seek out any other psychiatric or psychological treatment during the study.
排除标准
- •affective disorders
- •anxiety disorders
- •psychotic disorders
- •personality disorders
- •substance use disorders in the past 6 months
- •pervasive developmental disorder
- •patients with an IQ lower than 85
- •patients receiving concurrent psychological interventions.
研究组 & 干预措施
CBT group
This group consist on a combined intervention: CBT group + psychopharmacological treatment. The group program was based on cognitive-behavioral principles and also motivational interviewing techniques to facilitate skills implementation. The treatment comprised 12 manualized sessions with an inattention module and an impulsivity module.
干预措施: CBT group (Behavioral)
Psychopharmacological treatment
Participants were only visited to monitor their adherence and continuation on medications for ADHD (methylphenidate or atomoxetine) as prescribed by their psychiatrist.
干预措施: Psychopharmacological treatment (Drug)
结局指标
主要结局
Post-treatment ADHD symptoms
时间窗: Post-treatment (after receiving 3 month treatment)
measured by ADHD Rating Scale (clinician-administered version for the adolescent and also parent informant). It is a 18 item scale which assesses the diagnostic criteria for ADHD and rates the frequency of each item on a 4 point Likert scale.
Post-treatment functional impairment
时间窗: Post-treatment (after receiving 3 month treatment)
Assessed by Weiss Functional Impairment Scale (WFIRS) self report and parent version (an appropriate measure for functional impairment associated with ADHD) and by GAF (Global Assessment of Functioning) evaluated by a blinded rater. It is a clinician-administered measure to assess clinical severity and functioning.
次要结局
- Post-treatment anger management(Post-treatment (after receiving 3 month treatment))
- Post-treatment anxiety symptoms(Post-treatment (after receiving 3 month treatment))
- Post-treatment depression symptoms(Post-treatment (after receiving 3 month treatment))
研究者
Raquel Vidal
PhD
Hospital Universitari Vall d'Hebron Research Institute