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

NCT05341297 | Completed

• 1 other identifier: GTC 31371/2020
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Problem; Anxiety; Depression; Psychological Distress

Keywords

Internet intervention; transdiagnostic; parent-led intervention; internalizing problems; children; Rational emotive and behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the Patient Health Questionnaire-4

  Baseline, 3 weeks and follow-up at 1 month after treatment termination

• Change in the Parental Self-Efficacy Scale

  Baseline, 3 weeks and follow-up at 1 month after treatment termination

• Change in the Family Accommodation Scale

  Baseline, 3 weeks and follow-up at 1 month after treatment termination

• Satisfaction with the intervention

  3 weeks after treatment initiation

Study Arms (2)

ParentKIT

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

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

Interventions

ParentKIT BEHAVIORAL

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.

ParentKIT

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• undergoing psychotherapy/ pharmacological treatment

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, 400015, Romania

Location

Related Publications (1)

• Poetar CR, Dobrean A, Andersson G. Preliminary efficacy of a transdiagnostic parent-led internet-delivered intervention for children with anxiety and depressive symptoms: a pilot randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2024 Mar 6;18(1):31. doi: 10.1186/s13034-024-00721-3.

  PMID: 38448874 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Costina R Păsărelu, Ph.D

  Babes-Bolyai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 22, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified data will be uploaded after publication of the results.
• Access Criteria: Upon the completion of the study, de-identified datasets will be available from the corresponding author on reasonable request.

Locations

RO (1)