A Transdiagnostic Internet Intervention for Parents of Children With Anxiety and Depressive Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of a transdiagnostic, parent-led, Internet-delivered intervention in reducing child and adolescent internalizing problems.

Detailed Description
-----------------
Anxiety and depressive symptoms are common in children and adolescents. There is substantial research indicating that transdiagnostic Internet interventions are effective for adults and children with anxiety and depressive disorders; however, there is limited research on the efficacy of such programs aimed at parents of children and adolescents with anxiety and depressive symptoms. This study aims to investigate the efficacy of a transdiagnostic Internet intervention for parents of children with elevated anxiety and depressive symptoms.

Official Title
-----------------
Digital Parent-led Transdiagnostic Interventions for Child and Adolescent Anxiety and Depressive Disorders

Conditions
-----------------
Emotional Problem, Anxiety, Depression, Psychological Distress

Intervention / Treatment
-----------------
* Behavioral: ParentKIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parent of a child/ adolescent aged 6 to 14 years elevated internalizing problems have Internet access Exclusion Criteria: undergoing psychotherapy/ pharmacological treatment

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ParentKIT<br>Transdiagnostic parent-led Internet-delivered intervention Participants in the experimental group will have access to the ParentKIT intervention. The intervention was developed based on existing Cognitive Behavioral Therapy/ Rational Emotive Behavior Therapy protocols for parents of children with internalizing problems. It consists of nine modules delivered over three weeks. | Behavioral: ParentKIT<br>* The intervention is structured in 9 modules through which parents learn to identify and manage their children's anxiety and depressive symptoms. The Internet intervention is guided by two psychotherapists under supervision training in Cognitive Behavioral Therapy, trained by the first author on the treatment protocol.<br>|
| No Intervention: Waitlist<br>Participants in the waitlist condition will have access to the program after 3 weeks. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the brief Revised Children's Anxiety and Depression Scale - parent version | Measure of child anxiety and depressive symptoms, as reported by parents. Scores range between 0 and 33; higher scores indicate higher anxiety and depressive symptoms. | Baseline, 3 weeks and follow-up at 1 month after treatment termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Patient Health Questionnaire-4 | Measure of anxiety and depressive symptoms - will be used to measure changes in parental distress. Scores range between 0 and 12. Higher scores indicate higher distress. | Baseline, 3 weeks and follow-up at 1 month after treatment termination | 
| Change in the Parental Self-Efficacy Scale | Measure of parental self-efficacy in relationship to parenting practices that may decrease anxiety and depression risks for adolescents. Total scores range between and 9 and 36. Higher scores indicate higher parental self-efficacy. | Baseline, 3 weeks and follow-up at 1 month after treatment termination | 
| Change in the Family Accommodation Scale | Measure of parental anxiety accommodations. Scores range between 0 and 52. Higher scores indicate higher parental anxiety accommodations. | Baseline, 3 weeks and follow-up at 1 month after treatment termination | 
| Satisfaction with the intervention | Client satisfaction will be measured with Client Satisfaction Questionnaire, short form (Attkisson & Zwick, 1982). Scores range from 8 to 32, with higher scores indicating greater satisfaction with the intervention. | 3 weeks after treatment initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internet intervention, transdiagnostic, parent-led intervention, internalizing problems, children, Rational emotive and behavioral therapy