Transdiagnostic REBT Prevention Program for Adolescents

February 7, 2023 updated by: Anca Dobrean, Babes-Bolyai University

The Efficacy of a Video-based Transdiagnostic REBT Universal Prevention Program Delivered in a School Context for Internalizing Problems in Adolescents

Anxiety and depressive disorders are common in adolescents, however they are often unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive behavioral therapy (CBT) is efficient for children and adolescents. School settings are appropriate environments to deliver such interventions for vulnerable youths. Given youth's access and predilection to use technology, a video-based prevention program was developed. The present study aims to investigate the efficacy of a transdiagnostic REBT prevention program for internalizing symptoms in adolescents, implemented in a school setting.

Classes from different Romanian public schools will be randomized in either intervention or wait list group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevention program will be group-based, delivered in 6 sessions, over 3 weeks.

Each of the six modules aimed a different component: Psychoeducation, Relaxation, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive restructuring, Exposure/ behavioral activation and problem solving, Maintenance of gainings. Despite specific activities, for each session a video cartoon on that subject will be viewed and discussed. Homework would be given at every session.

REBT prevention programs delivered in school settings represent ecological modalities to target vulnerable groups. Technology components added to traditional programs may lead to greater motivation and satisfaction with treatment.

Adolescents will complete assessments at four time-points: T1 (baseline), T2 (post-intervention), T3 (3 months follow-up) and T4 (12 months follow-up).

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Preadolescents and adolescents will have ages between 12 and 17 years old;
  2. Are attending middle school or high-school;
  3. Adolescents have sufficient understanding of the Romanian language in order to complete assessments at all time points and to participate in the prevention program;
  4. Their parents have sufficient understanding of the Romanian language in order to sign the informed consent;
  5. Parents will sign the informed consent and adolescents will provide informed assent.

Exclusion Criteria:

  1. Age below 14 or above 17 years;
  2. No signed informed consent from parents;
  3. Adolescents will score high on suicidal ideation according to (1 item on the Depression subscale from Beck Youth Inventories);
  4. Not Romanian-speaking in order to understand the content of the prevention program and to complete the assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: video-based transdiagnostic REBT
Children and adolescents in the experimental group attend 6 modules of video-based transdiagnostic rational emotive behavioral therapy (REBT). Each of the six modules aimes a different component: Psychoeducation, Relaxation, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive restructuring, Exposure/ behavior activation and problem solving, Maintenance of gaining.
Behavioral: video-based transdiagnostic REBT
The video-based transdiagnostic REBT consists of 6 sessions delivered in a group format.
SHAM_COMPARATOR: wait list
The wait-list is a delayed treatment condition.
Behavioral: Wait list
Delayed intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Multidimensional Anxiety Scale for Children (MASC; March, Parker, Sullivan, Stallings, & Conners, 1997)
Time Frame: Change from baseline anxiety symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
anxiety symptoms
Change from baseline anxiety symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
Beck Depression Inventory for Youth subscale from the Beck Youth Inventories-Second edition for children and adolescents (Beck, 2005)
Time Frame: Change from baseline depressive symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
depressive symptoms
Change from baseline depressive symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Children's Automatic Thoughts Scale - Negative/Positive (CATS-N/P) (Hogendoorn et al., 2010)
Time Frame: Change from baseline maladaptive cognitions at 3 weeks post-intervention, 3 month follow up, 12 months follow-up
maladaptive cognitions
Change from baseline maladaptive cognitions at 3 weeks post-intervention, 3 month follow up, 12 months follow-up
The Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997)
Time Frame: Change from baseline comorbid problems at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
comorbid problems
Change from baseline comorbid problems at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
The Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, The Revised Version - adolescent version (Kiddo-KINDL) (Ravens-Sieberer et al., 2001)
Time Frame: Change from baseline quality of life at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
quality of life
Change from baseline quality of life at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
The Credibility/ Expectancy Questionnaire (Devilly & Borkovec, 2000)
Time Frame: pre-intervention
Treatment expectancies
pre-intervention
The Client Satisfaction Scale (Vigerland et al., 2016)
Time Frame: post-intervention
Satisfaction with the intervention
post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Babes-Bolyai University

Investigators

  • Study Director: Anca Dobrean, Ph.D., Babeș-Bolyai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (ESTIMATE)

April 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN-II-PT-PCCA-2011-3.1-1500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon reasonable request.

IPD Sharing Time Frame

Data will be shared upon reasonable request after the publication of the manuscripts resulting from this study.

IPD Sharing Access Criteria

Data will be requested from the corresponding author of the resulting papers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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