A Randomized Controlled Trial of Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in parental emotion regulation at 6 weeks and 4 months
研究概览
简要总结
Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly.
This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention.
详细描述
This randomized controlled trial (RCT) will test the efficacy of a 6-week Emotion Focused Family Therapy (EFFT) group program on parent and child outcomes, compared to a waitlist control. Families will be randomized to either the EFFT group treatment or a waitlist. The RCT will evaluate changes in parent functioning, child functioning, and parent-child relationship functioning. A 4-month follow-up will test whether any changes from pre-to-post intervention are maintained at 4 months.
The RCT will also test proposed mechanisms of change (parent-child relationship quality, family functioning) and moderators of treatment effectiveness (parental stress).
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent of child aged 7 to 15 years old with anxiety, depression, or behavioural challenges
- •Parent of child is willing to participate in intervention
- •Parent is living at home with the child
排除标准
- •Parent or child not proficient enough in speaking/understanding English to complete measures or EFFT intervention components
- •Parent or child with a severe mental health disorder (e.g., active suicidality and psychosis) is not considered suitable for the trial intervention due to the clinical need for immediate intervention
- •Parent or child is actively receiving, or due to receive, intensive psychological intervention focused on cognitive and/or behavioural strategies to intervene with emotional or behavioural difficulties
- •Parent or child has any disabilities in language, speech or hearing that would interfere with their completion of the EFFT and measures
- •Parent or child are allergic to adhesive electrode gel use in some tasks (i.e., sodium chloride)
研究组 & 干预措施
Waitlist (delayed intervention)
No treatment will be administered to participants in this arm until after the 4-month follow-up in-lab assessment is completed.
EFFT intervention
Treatment (6-week group Emotion Focused Family Therapy) will be administered to participants in this arm.
干预措施: Emotion Focused Family Therapy (Behavioral)
结局指标
主要结局
Change in parental emotion regulation at 6 weeks and 4 months
时间窗: Change at 6 weeks; Change at 4 months
This outcome will be measured through the Difficulties in Emotion Regulation Scale (DERS), a 36-item self-report measure of emotion regulation difficulties to be completed by parents. Parents will indicate the frequency with which they experience difficulties with emotion regulation on a five-point Likert scale from 1 (Almost never) to 5 (Almost always), with greater total scores (range = 36-180) indicating greater difficulties with emotion regulation.
Change in parental psychopathology symptoms at 6 weeks and 4 months
时间窗: Change at 6 weeks; Change at 4 months
This outcome will be measured through the Kessler Psychological Distress Scale (K10), a 10-item self report measure of psychological symptoms that parents will complete. Parents will rate the extent to which they are affected by various psychopathology symptoms on a five-point Likert scale from 1 (None of the time) to 5 (All of the time), with greater total scores (range = 10-50) indicating more severe psychopathology.
Change in parent-child relationship functioning at 6 weeks and 4 months
时间窗: Change at 6 weeks; Change at 4 months
This outcome will be measured by having parents and their children participate in two lab tasks together (conflict discussion and puzzle task) and coding for behavioural observations.
Change in child psychopathology symptoms at 6 weeks and 4 months
时间窗: Change at 6 weeks; Change at 4 months
This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by both parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem), with greater scores (Internalizing subscale range = 0-24; Externalizing subscale range = 0-24; Total score range = 0-48) indicating more severe psychopathology.
Change in child emotion regulation at 6 weeks and 4 months
时间窗: Change at 6 weeks; Change at 4 months
This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report). Parents and children will rate the seven Negative Emotionality items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7-28) indicating poorer emotion regulation.
Change in parent-child co-regulation at 6 weeks and 4 months
时间窗: Change at 6 weeks; Change at 4 months
This outcome will be measured by parent-child synchrony of heart rate variability during the completion of two lab tasks together (conflict discussion and puzzle task).
次要结局
- Change in parental emotion socialization at 6 weeks and 4 months(Change at 6 weeks; Change at 4 months)
- Change in physiological arousal at 6 weeks and 4 months(Change at 6 weeks; Change at 4 months)
- Change in parental self-efficacy at 6 weeks and 4 months(Change at 6 weeks; Change at 4 months)
- Change in parental emotion blocks at 6 weeks and 4 months(Change at 6 weeks; Change at 4 months)
- Fidelity of EFFT program(Throughout intervention over 6 weeks)
- Parental treatment satisfaction(At 6 weeks)
- Change in perceived parental stress at 6 weeks and 4 months(Change at 6 weeks; Change at 4 months)
- Parent-reported change in familial functioning at 6 weeks and 4 months(Change at 6 weeks; Change at 4 months)
研究者
Kristel Thomassin
Associate Professor
University of Guelph