Anxiety Disorders Clinical Trial
Official title:
Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents - a Randomized Controlled Trial
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 - 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Recruiting |
NCT05419934 -
EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial
|
N/A | |
Active, not recruiting |
NCT04136054 -
Better Sleep in Psychiatric Care - Anxiety and Affective Disorders
|
N/A | |
Completed |
NCT04091139 -
Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
|
Phase 2/Phase 3 | |
Completed |
NCT04647318 -
Physiological Response to Self-compassion Versus Relaxation
|
N/A | |
Active, not recruiting |
NCT05114824 -
Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students
|
N/A | |
Recruiting |
NCT05843695 -
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
|
N/A | |
Completed |
NCT05078450 -
Mood Lifters Online for Graduate Students and Young Professionals
|
N/A | |
Not yet recruiting |
NCT06162624 -
Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
|
N/A | |
Not yet recruiting |
NCT05747131 -
Emotion Detectives In-Out: Feasibility and Efficacy of a Blended Version of the Unified Protocol for Children
|
N/A | |
Not yet recruiting |
NCT05863637 -
Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting
|
N/A | |
Not yet recruiting |
NCT05225701 -
Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders.
|
N/A | |
Completed |
NCT02579915 -
Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC)
|
N/A | |
Recruiting |
NCT02186366 -
Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type
|
N/A | |
Recruiting |
NCT02376959 -
Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers
|
N/A | |
Not yet recruiting |
NCT02126787 -
Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment
|
N/A | |
Withdrawn |
NCT01953042 -
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
|
N/A | |
Completed |
NCT02134730 -
School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial
|
N/A | |
Completed |
NCT01636791 -
CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care
|
Phase 3 |