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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).
RESEARCH QUESTIONS
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Health Utility-9 Dimensions (CHU9D) at post-intervention, 12-month, and 36 month follow-up | CHU9D is a validated parent-rated questionnaire of the child's quality of life, including 9 items (each item scored 1-5 where lower scores indicates better quality of life). | Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Solna | 171 65 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40077809 | Derived | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 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. |
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| Change in EQ5D at post-intervention, at post-intervention, 12-month, and 36 month follow-up | EQ5D is a validated self-rated questionnaire of the parent's quality of life, including 5 items (each item scored 1-3 where lower scores indicates better quality of life). | 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 | The EEAC is a validated self-rated questionnaire of the parent's positive and negative emotions directed towards the child. The EEAC include 20 adjectives (each scored 1-8 where 1 indicates never and 8 always. | 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 | RPOS is a revised version of the validated self-rated questionnaire of the parent's overprotective behaviors, including 11 items (each item scored 1-5 where higher scores indicates more overprotective behaviors). | 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 | MPAQ is a self-rated questionnaire of the parent's modelling of anxious and non-anxious behaviours (two different sub-scales), including 7+9 items (each item scored 1-5 where higher scores indicates more modelling). | Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up |
| Change in the Screen for Child Anxiety Related Disorders Revised (SCARED-R) at post-intervention, 12-month, and 36 month follow-up | SCARED-R is a validated parent-rated questionnaire of the child's anxiety symptoms including 41 items (each item scored 0-2 where higher scores indicates more anxiety symptoms). | Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up |
| 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 | The PHQ-9 is a validated self-rated questionnaire of the parent's depression symptoms, including 9 items, (each item scored 0-3 where higher scores indicates more depressive symptoms). | Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up |
| Change in PROMIS-Anxiety Short Form at post-intervention, 12-month, and 36 month follow-up | The PROMIS Anxiety Short Form is a validated self-rated questionnaire of the parent's anxiety symptoms, including 8 items, (each item scored 1-5 where higher scores indicates more anxiety symptoms). | Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up |
| Change in Family Accommodation Scale-Anxiety Parent Report (FASA-PR) at post-intervention, 12-month, and 36 month follow-up | The FASA-PR is a validated self-rated questionnaire of the parent's accommodation to the child's anxiety, including 13 items (each item scored 0-4 where higher scores indicates more accommodation). | Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up |
| Change in Parenting Sense of Competence Scale (PSOC) at post-intervention, 12-month, and 36 month follow-up | PSOC is a validated self-reported questionnaire of the parent's sense of competence, including 11 items (each item scored 1-6 where higher scores indicates more sense of competence). | Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up |
| Use of societal resources past three months (an adapted version of the TIC-P questionnaire) | TIC-P (Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness) is a questionnaire including questions about healthcare social support medications, parental absence from work, absence from school and productivity loss in school. | Assessed at Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up |