Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Child Behaviour Checklist
研究概览
简要总结
Strongest Families (formerly Family Help)is an evidence-based, distance health education model for families who have children with behavioural difficulties. The principal research question is "Does Strongest Families, a 12-week, home-based program of interactive readings, instructional videos, homework projects, and weekly "coaching" telephone calls out perform the care families typically experience when referred to a mental health service?". The investigators hypothesize that children randomized to Strongest Families intervention will show a significantly greater reduction in externalizing behaviour problems than those randomized to a Control (usual care). In addition, parents randomized to Family Help will report a greater improvement in parenting skills and a greater reduction in symptoms of emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the Control condition. Finally, families randomized to Family Help will use fewer mental health services than Controls.
详细描述
Our project is designed to help families and children with mild or moderate symptoms early, before problems become worse and more difficult to treat.
The Strongest Families Program is a distance parenting program that was developed at the Centre for Research in Family Health at the IWK Health Centre in Halifax, Nova Scotia. Most families are able to manage these problems if they are given the skills to do so. The Strongest Families "Parenting the Active Child" Distance Program is done over the telephone; families do not have to travel to a centre to receive help. This program includes a handbook, videos and weekly phone calls between the parent and non-professional'coach'. The coach provides support to families, answer questions and guide parents as they learn the skills. Strongest Families has helped hundreds of families in Nova Scotia.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female individuals who meet all the following criteria are eligible for this trial:
- •Child is aged 6 to 12 years and
- •Completed and signed referral form from a participating intake site is received and
- •Parent/legal guardian provides verbal, telephone consent to participate and
- •Ability of participant to read and understand English (at a Grade 5 level) and
- •There must be the reasonable intention that for the study duration the child will remain in the direct care of the participant and at the same address as the participant (2 years) and o Child presents with significant levels of disruptive behaviour based on the BCFPI results at the referring agent end and clinical evaluation of the corroborative study assessment measures.
排除标准
- •Participants meeting one or more of the following criteria cannot be selected:
- •Child is in the care of a child protective agency or currently being investigated by a child protective agency
- •Child has received any form of behavioural treatment in the past 6 months
- •Child is at an imminent risk of harm to themselves or others
- •In the judgment of the investigator or delegate, any condition that may interfere with effective delivery of the study protocol/intervention program (i.e., High parental DASS-21 score, complex child symptomology, families who are unmotivated or are in complete chaos)
研究组 & 干预措施
Strongest Families Program + Usual care
50% randomized to receive Strongest Families intervention immediately as well as the usual care services available via the referring agency for the 22 month study period.
干预措施: Strongest Families Intervention (formerly Family Help) (Behavioral)
Usual care
50% randomized will not receive Strongest Families Intervention during the 22 month study phase, but will receive the usual care services available via the referring agency. At the end of the 22 month study period study participants will be offered the Strongest Families Intervention services.
结局指标
主要结局
Child Behaviour Checklist
时间窗: Baseline, 5, 10, 16, 22 months
Results will be analyzed as change from baseline over time
次要结局
- Alabama Parenting questionnaire(Baseline, 5, 10, 16, 22 months)
- SCAPI (economic)(Baseline,5, 10, 16, 22)
- DASS-21(Baseline,5, 10, 16, 22)
- Investigator designed disability measure(weekly during intervention)
- Discrete Conjoint Preference survey: Investigator designed(baseline, 5, 16 months)
- Investigator designed Satisfaction measure(end of intervention)