Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents

NCT04722731 | Unknown

• 1 other identifier: JASE01
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anxiety Disorders

Keywords

Prevention; Childhood anxiety; Parent program

Outcome Measures

Primary Outcomes (1)

• Change in severity of childhood anxiety disorder as rated by clinician at 12-month, and 36 month follow-up

  Clinical Severity Ratings (CSR, ranging from 0 to 8, where a value of 4 and higher indicate that the child meet criteria for an anxiety disorder). The CSR is extracted from the Anxiety Disorders Interview Schedule - Schedule for Children (ADIS-C). The CRS is rated by clinician based on interviewing with primary caregiver.

  Base-line assessment, 12 month follow-up, 36 month follow-up

Secondary Outcomes (11)

• Change in Child Health Utility-9 Dimensions (CHU9D) at post-intervention, 12-month, and 36 month follow-up

  Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up

• Change in EQ5D at post-intervention, at post-intervention, 12-month, and 36 month follow-up

  Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up

• Change in Expressed Emotion Adjective Checklist (EEAC) at post-intervention, 12-month, and 36 month follow-up

  Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up

• Change in the Revised Parental Overprotective Scale (RPOS) at post-intervention, 12-month, and 36 month follow-up

  Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up

• Change in the Modelling of Parental Anxiety Questionnaire (MPAQ) at post-intervention, 12-month, and 36 month follow-up

  Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up

Study Arms (2)

Confident Parents - Brave Children

EXPERIMENTAL

The Confident Parents - Brave Children (CPBT) is a group parent training targeted to anxious parents, delivered by a psychologist via video conference (the Zoom software solution). The CPBT will comprise six 120-minutes digital sessions. One month after the last group session, all parents will be offered to have an individual booster session with a psychologist over Zoom.

Behavioral: Confident Parents - Brave Children (CPBT)

Self-help book

ACTIVE COMPARATOR

In the control group, participants will receive a parenting book, titled "What all parents ought to know". This is a self-help book for parents, partly based on the scientifically evaluated parent program "All Children in Focus".

Behavioral: Self-help book "What all parents ought to know"

Interventions

Confident Parents - Brave Children (CPBT) BEHAVIORAL

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.

Confident Parents - Brave Children

Self-help book "What all parents ought to know" BEHAVIORAL

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.

Self-help book

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Solna, 171 65, Sweden

Location

Related Publications (1)

• Elfstrom S, Rosengren A, Andersson R, Engelbrektsson J, Isaksson A, Meregalli M, van Leuven L, Lalouni M, Ost LG, Ghaderi A, Ahlen J. Evaluating a program to prevent anxiety in children of anxious parents: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Sep;66(9):1345-1356. doi: 10.1111/jcpp.14151. Epub 2025 Mar 12.

  PMID: 40077809 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project coordinator

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: February 15, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

SE (1)