Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anxiety Disorders
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 5 years and 9 years
- Gender
- Both males and females
Description
RESEARCH QUESTIONS Is the CPBC-program effective in preventing childhood anxiety disorders within a period of 12 and 36 months respectively, compared to a self-help parenting book? Is the CPBC-program effective in preventing childhood anxiety symptoms within a period of 12 and 36 months respectively...
RESEARCH QUESTIONS Is the CPBC-program effective in preventing childhood anxiety disorders within a period of 12 and 36 months respectively, compared to a self-help parenting book? Is the CPBC-program effective in preventing childhood anxiety symptoms within a period of 12 and 36 months respectively, compared to a self-help parenting book? Is the effect moderated by severity of parental anxiety, child anxiety symptoms at baseline, or gender or age of the child? Is the study effective in increasing parental self efficacy? Is the effect of CPBC-program mediated by changes in parental criticism and rejection, overprotection, parental modelling of anxiety or parental accommodation? Is the CPBC-program cost-effective? DESIGN The first study is a full scale parallel randomised controlled trial (allocation ratio 1:1). This study will include follow-up assessments after 12 and 36 months and will evaluate the relative efficacy of the CPBC-program versus an active control group (self-help book). The second part includes a mediation analysis and the third part is a within trial economic evaluation comparing the outcomes and costs between the CPBC-program and control using two types of analyses (cost-utility analysis and cost-consequence analysis). POWER To have an 80% power to detect a significant (p ? 0.05) small to moderate difference (standardised mean difference = 0.4) the investigators will need to recruit 194 children. Given an anticipated attrition of 10%, the investigators will aim at including a total of 216 children. Participants will be recruited through advertisements. The participants will be randomly allocated to either (1) CPBC-program or (2) reading a self-help book.
Tracking Information
- NCT #
- NCT04722731
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon