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

• Sponsor: Babes-Bolyai University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05341297
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 7.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Emotional Problem; Anxiety; Depression; Psychological Distress	Behavioral: ParentKIT	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Digital Parent-led Transdiagnostic Interventions for Child and Adolescent Anxiety and Depressive Disorders
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in the brief Revised Children's Anxiety and Depression Scale - parent version [Baseline, 3 weeks and follow-up at 1 month after treatment termination]

   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

1. Change in the Patient Health Questionnaire-4 [Baseline, 3 weeks and follow-up at 1 month after treatment termination]

   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.

2. Change in the Parental Self-Efficacy Scale [Baseline, 3 weeks and follow-up at 1 month after treatment termination]

   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.

3. Change in the Family Accommodation Scale [Baseline, 3 weeks and follow-up at 1 month after treatment termination]

   Measure of parental anxiety accommodations. Scores range between 0 and 52. Higher scores indicate higher parental anxiety accommodations.

4. Satisfaction with the intervention [3 weeks after treatment initiation]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• elevated internalizing problems

• have Internet access

Exclusion Criteria:

• undergoing psychotherapy/ pharmacological treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Babes-Bolyai University	Cluj-Napoca		Romania	400015

Sponsors and Collaborators

• Babes-Bolyai University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Costina-Ruxandra Păsărelu, Assistant professor, Babes-Bolyai University
• ClinicalTrials.gov Identifier: NCT05341297
• Other Study ID Numbers: GTC 31371/2020
• First Posted: Apr 22, 2022
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Costina-Ruxandra Păsărelu, Assistant professor, Babes-Bolyai University: Internet intervention; transdiagnostic; parent-led intervention; internalizing problems; children; Rational emotive and behavioral therapy
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Apr 22, 2022