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

Primary Purpose

Emotional Problem, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
ParentKIT
Sponsored by
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Problem focused on measuring Internet intervention, transdiagnostic, parent-led intervention, internalizing problems, children, Rational emotive and behavioral therapy

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • parent of a child/ adolescent aged 6 to 14 years
  • elevated internalizing problems
  • have Internet access

Exclusion Criteria:

  • undergoing psychotherapy/ pharmacological treatment

Sites / Locations

  • Babes-Bolyai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ParentKIT

Waitlist

Arm Description

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.

Participants in the waitlist condition will have access to the program after 3 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change in the Family Accommodation Scale
Measure of parental anxiety accommodations. Scores range between 0 and 52. Higher scores indicate higher parental anxiety accommodations.
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.

Full Information

First Posted
April 11, 2022
Last Updated
September 12, 2023
Sponsor
Babes-Bolyai University
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1. Study Identification

Unique Protocol Identification Number
NCT05341297
Brief Title
A Transdiagnostic Internet Intervention for Parents of Children With Anxiety and Depressive Symptoms
Acronym
ParentKIT
Official Title
Digital Parent-led Transdiagnostic Interventions for Child and Adolescent Anxiety and Depressive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Problem, Anxiety, Depression, Psychological Distress
Keywords
Internet intervention, transdiagnostic, parent-led intervention, internalizing problems, children, Rational emotive and behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ParentKIT
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants in the waitlist condition will have access to the program after 3 weeks.
Intervention Type
Behavioral
Intervention Name(s)
ParentKIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the brief Revised Children's Anxiety and Depression Scale - parent version
Description
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.
Time Frame
Baseline, 3 weeks and follow-up at 1 month after treatment termination
Secondary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire-4
Description
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.
Time Frame
Baseline, 3 weeks and follow-up at 1 month after treatment termination
Title
Change in the Parental Self-Efficacy Scale
Description
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.
Time Frame
Baseline, 3 weeks and follow-up at 1 month after treatment termination
Title
Change in the Family Accommodation Scale
Description
Measure of parental anxiety accommodations. Scores range between 0 and 52. Higher scores indicate higher parental anxiety accommodations.
Time Frame
Baseline, 3 weeks and follow-up at 1 month after treatment termination
Title
Satisfaction with the intervention
Description
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.
Time Frame
3 weeks after treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Costina R Păsărelu, Ph.D
Organizational Affiliation
Babes-Bolyai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Babes-Bolyai University
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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