Clinical trial NCT04722731: Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents
Official title: Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Keywords: Prevention
Childhood anxiety
Parent program
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 215
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: Inclusion Criteria:

1. The parent suffers from exaggerated worry or anxiety
2. The parent speaks and reads Swedish
3. The child is 5-9 years old
4. 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:

1. Current or recent parental alcohol or substance abuse
2. The parent suffer from severe psychiatric conditions (e.g.current or recent psychotic or manic/hypomanic symptoms, severe depression or increased risk of suicide)
3. Social conditions that would obstruct from participation (e.g.ongoing custody dispute, domestic violence, ongoing investigation of child neglect through social services)
4. The child suffers from/is currently in treatment for an anxiety disorder or depression
5. The child is currently undergoing a neuropsychological evaluation
6. 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 )
7. 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 )

Primary outcomes:
measure: Change in severity of childhood anxiety disorder as rated by clinician at 12-month, and 36 month follow-up
timeFrame: Base-line assessment, 12 month follow-up, 36 month follow-up
Secondary outcomes:
measure: Change in Child Health Utility-9 Dimensions (CHU9D) at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in EQ5D at post-intervention, at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in Expressed Emotion Adjective Checklist (EEAC) at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in the Revised Parental Overprotective Scale (RPOS) at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in the Modelling of Parental Anxiety Questionnaire (MPAQ) at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in the Screen for Child Anxiety Related Disorders Revised (SCARED-R) at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in the PHQ 9 at post-intervention, 12-month, and 36 month follow-up Change in the Patient Health Questionnaire (PHQ-9) at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in PROMIS-Anxiety Short Form at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in Family Accommodation Scale-Anxiety Parent Report (FASA-PR) at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Change in Parenting Sense of Competence Scale (PSOC) at post-intervention, 12-month, and 36 month follow-up
timeFrame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
measure: Use of societal resources past three months (an adapted version of the TIC-P questionnaire)
timeFrame: Assessed at Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
References: