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

Depression Clinical Trial

— ParentKIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341297
• Other study ID #: GTC 31371/2020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• parent of a child/ adolescent aged 6 to 14 years

• elevated internalizing problems

• have Internet access

Exclusion Criteria:

• undergoing psychotherapy/ pharmacological treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Emotional Problem
• Psychological Distress

Intervention

Behavioral:
• ParentKIT
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.

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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