Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 464
- 试验地点
- 2
- 主要终点
- CHild Behaviour Checklist (to measure change from baseline)
研究概览
简要总结
The goal of the Strongest Families Finland Canada project is to help parents develop skills to strengthen their families and reduce disruptive behavior in their 4 year old children.
详细描述
This project will have two phases, described below. The first part will be development of the web based program, the second part will be the implementation of the program in Finland. All participants will be recruited in Finland and all research activities will take place in Finland, by the Finnish Consortium. The Canadian Consortium will assist in funding and provide expert support.
Part 1: Website development:
The Strongest families program provides evidence based psychological and behavioural interventions to families with children with mild to moderate mental health problems. Parents work through a handbook with exercises, watch instructional videos and participate in weekly phone calls from a trained 'coach' (paraprofessional) to provide support, respond to parents' questions and highlight the skills included in a handbook. The preliminary analysis of a Strongest Families effectiveness trial based at the Izaak Walton Killam Children's Hospital (IWK) Health Centre (Projects #2234, and #2654) and effect size reports from the IWK Strongest families Service Program suggest that Strongest Families is an effective treatment for Oppositional Defiant Disorder (ODD).
Strongest Families is an adaptation of the COPE program. COPE is a large-group parent training program (average 25 families per group) that has been evaluated and used in many centres across Canada, the United States and Europe. It was developed at McMaster University by a team led by Dr. Charles Cunningham (one of the investigators on this submission). The groups use a coping modelling problem solving approach to skill acquisition which encourages parents to discuss the solution to common problems, collaborate in the formulation of child management strategies, share successes, and provide supportive feedback. Large group discussions may also provide more information regarding normal child development and a greater perspective on common child management difficulties than clinic/individual parent training .
The benefits for parents participating in COPE group sessions are many, but the burden of traveling to receive services can impede attendance, especially for families in rural areas. One solution to this issue would be to adapt individualized Strongest Families to a more accessible mode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is 4 years old at time of recruitment
- •Parent/guardian has access to a computer and the internet
- •Parent/guardian is comfortable reading at a Grade 5 level
- •Child meets screening criteria (SDQ score of 4 or more with some problems per impact score)
- •Child has had behavioural challenges for the last 6 months
- •Parent has access to phone in home
- •Parent speaks/writes Finnish
排除标准
- •- Has received or is receiving behavioral treatment (parent training) before
- •Diagnosis of:
- •Autism or a Pervasive development disorder (PDD)
- •Down's syndrome
- •Fetal Alcohol Syndrome
- •Mental retardation
- •Genetic diagnosis that will lead to mental retardation
- •Major mental health disorder (e.g., depression, psychosis)
- •Child is not speaking using a sentence
- •Child is deaf or blind
结局指标
主要结局
CHild Behaviour Checklist (to measure change from baseline)
时间窗: Measure change from baseline at 6 & 12 months
Measure of child behavioural change from baseline to 6 \& 12 months
次要结局
- Child Behaviour Checklist- Teacher version (to measure change since baseline)(Measure change from Baseline to 6 & 12 months)
- Strengths & Difficulties Questionnaire (Screening Tool)(Screening)
- Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish(Baseline, 6 & 12months)
- The Parenting Scale (To measure change from baseline to 6 & 21 months)(To measure change from baseline to 6 & 12 months post randomization)
- Barkley's Quick-Screen: The Barkley Adult ADHD Rating Scale IV (to measure change from baseline)(Measure change from baseline to 6&12 months)
- Satisfaction measure: Researcher designed for the Intervention group(end of program intervention (average is about 5 months but timing of completion varies between participants.))
- The Sense of Coherence Scale (SOC-13)(Measure change from Baseline to 6 & 12 months)
- The Parent Problem Checklist(Measure change from Baseline to 6 & 12 months)
- The Inventory of Callous-Unemotional Traits(Measure change from Baseline to 6 & 12 months)