Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    216
  • sponsor
    Karolinska Institutet
Updated on 22 April 2022
Accepts healthy volunteers

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).

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.

Details
Condition Anxiety Disorders
Treatment Confident Parents - Brave Children (CPBT), Self-help book "What all parents ought to know"
Clinical Study IdentifierNCT04722731
SponsorKarolinska Institutet
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The parent suffers from exaggerated worry or anxiety
The parent speaks and reads Swedish
The child is 5-9 years old
The child receives a clinicians assigned clinical severity rating (CSR) of 1 to 3 on anxiety disorders in ADIS-C (subclinical symptoms of anxiety)

Exclusion Criteria

Current or recent parental alcohol or substance abuse
The parent suffer from severe psychiatric conditions (e.g.current or recent psychotic or manic/hypomanic symptoms, severe depression or increased risk of suicide)
Social conditions that would obstruct from participation (e.g.ongoing custody dispute, domestic violence, ongoing investigation of child neglect through social services)
The child suffers from/is currently in treatment for an anxiety disorder or depression
The child is currently undergoing a neuropsychological evaluation
The child has no symptoms of anxiety at all (the child receives a clinicians assigned CSR of 0 on all anxiety disorders in the ADIS-C interview )
The child meet criteria for an anxiety disorder (the child receives a clinicians assigned CSR of 4 or above on any anxiety disorder in ADIS-C interview )
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