Treatment of Children With Peer Related Aggressive Behavior With the Treatment Programme THAV - a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression
研究概览
简要总结
The efficacy of the Treatment Program for Children with Aggressive Behaviour (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) which is a social competence training delivered in an individual format will be evaluated in a randomized controlled trial with children aged 6 to 12 years with peer-related aggressive behaviour.
详细描述
The German Treatment Program for Children with Aggressive Behaviour (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) aims at the therapy of children aged 6 to 12 years with peer-related aggressive behaviour, which results in a persistent impairment of the relationships to other children. Contrary to other treatment approaches, this intervention aims at the individual treatment of problem maintaining and moderating factors of aggressive behaviour. Depending on the individual problem maintaining factors the treatment aims to modify social cognitive information processing, impulse control, social problem solving, social skills and social interactions. Methods: The efficacy will be tested in a partial randomized control group design with n=100 children. N=60 children will be treated for about half a year with the modules of THAV in weekly sessions. The control group of n=40 children will receive alternative interventions with group play and techniques to activate resources of the child. These interventions give the children the opportunity to train pro-social interactions. Outcome parameters are aggressive behaviour und comorbid symptoms as well as problem maintaining factors, psychosocial functioning, family burden and treatment satisfaction. Moreover, variables of the treatment process are assessed. Questionnaires, tests and individual problem checklist were used to assess these outcome and process parameters
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 (Participant)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 6 - 12 years
- •Diagnoses (ICD-10): F91, F92, F90.1
- •high symptom score in the parent rated Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) (Stanine ≥ 7) at assessment 1 and assessment 2
- •Often conflicts with other children (clinical rating)
- •Impaired social relationships / activities
- •Parents agree in randomization
- •in medicated children no planned change of the medication
排除标准
- •other disorder is dominating
- •other active psychotherapy
- •severe mental disorder of the parents
结局指标
主要结局
Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression
时间窗: Change from pre- assessment to post assessment 30 weeks after treatment begin and to follow up 3 months and 9 months after post assessment
The Questionnaire for Aggressive Behavior of Children (FAVK) is a newly developed parent rating scale which assesses several factors of peer related aggression: (1) disturbance of social cognitive information processing, (2) disturbance of social problem solving and social skills, (3) disturbance of impulse control, and (4) disturbance of social interaction. These scores a summed to a total score
次要结局
- Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher rating(change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment)
- Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)(change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment)
- Change in KINDL rating scale for quality of life(change form pre assessment to post assessment 30 weeks after treatment begin)
- Change in Modified WFIRS (Weiss Functional Impairment Rating Scale)(change form pre assessment to post assessment 30 weeks after treatment begin)
- Change in Individual Problem Checklist (IPC)(change form pre assessment to post assessment 30 weeks after treatment begin)
- Change in Social Problem Solving Test (SPST)(change form pre assessment to post assessment 30 weeks after treatment begin)
- Change in Five minutes speech sample (FMSS)(change form pre assessment to post assessment 30 weeks after treatment begin)
- Change in Depression Anxiety and Stress Questionnaire (DASS)(change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment)
研究者
Manfred Doepfner
Manfred Doepfner, Prof. Dr.
University of Cologne