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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05341297
Other study ID # GTC 31371/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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