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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Psychological Distress; Emotional Problem
• Intervention / Treatment: Behavioral: ParentKIT

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania, 400015
    • Babes-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ParentKIT; 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; 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.
No Intervention: Waitlist; 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

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Investigators: Principal Investigator: Costina R Păsărelu, Ph.D, Babes-Bolyai University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: children; transdiagnostic; Internet intervention; internalizing problems; parent-led intervention; Rational emotive and behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: GTC 31371/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be uploaded after publication of the results.
• IPD Sharing Time Frame: De-identified data will be uploaded after publication of the results.
• IPD Sharing Access Criteria: Upon the completion of the study, de-identified datasets will be available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No