NCT04722731

Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents

Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents - a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Accepted

Summary

This study aims to expand the evidence of prevention of anxiety disorders in children. Children of anxious parents are at increased risk of developing anxiety disorders. Twin studies support a direct environmental transmission of anxiety between parent and child, and a main mechanism is suggested to be the parenting style of anxious parents, characterised by criticism and rejection, overprotection and modelling of anxiety. This study will take a novel approach to prevent childhood anxiety disorders by evaluating the Confident Parents - Brave Children (CPBC) program, a parent program targeting anxious parents, in a randomised controlled trial (RCT).

Detailed 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, 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.

Conditions

• Anxiety Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Confident Parents - Brave Children (CPBT)	Session 1: Psychoeducation. Session 2: How to decrease criticism and rejection. Skills that provide a warm parenting style and acceptance of the child: validation and child directed play/activities. Session 3: Strategies to increase the autonomy of the child. The parents will learn how to use a stepladder approach to decrease overprotective behaviours. Session 4: How to decrease modelling of anxious behaviours and how to be a brave role model. Session 5: How to recognise and respond when your child is anxious. How to help your child approach new or scary things by using a stepladder approach. Session 6: Review of the principles and skills learned during the program. The group members will make a plan for how to continue the work on their own.
BEHAVIORAL	Self-help book "What all parents ought to know"	Participants in the control group will receive a self-help parenting book containing general research-based parenting strategies. They will be instructed to read the book within the 10 weeks from baseline to post.

Timeline

• Start date: 2021-02-15
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2021-01-25
• Last updated: 2023-10-04

Locations

1 site across 1 country: Sweden