Transdiagnostic REBT Prevention Program for Adolescents

NCT02756507 | Completed DMC

• 1 other identifier: PN-II-PT-PCCA-2011-3.1-1500
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Anxiety; Major Depression Mild; Panic Disorder; Specific Phobia; Generalized Anxiety Disorder

Keywords

anxiety symptoms; depression symptoms; internalizing symptoms

Outcome Measures

Primary Outcomes (2)

• The Multidimensional Anxiety Scale for Children (MASC; March, Parker, Sullivan, Stallings, & Conners, 1997)

  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)

  depressive symptoms

  Change from baseline depressive symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up

Secondary Outcomes (5)

• The Children's Automatic Thoughts Scale - Negative/Positive (CATS-N/P) (Hogendoorn et al., 2010)

  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)

  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)

  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)

  pre-intervention

• The Client Satisfaction Scale (Vigerland et al., 2016)

  post-intervention

Study Arms (2)

video-based transdiagnostic REBT

EXPERIMENTAL

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

wait list

SHAM COMPARATOR

The wait-list is a delayed treatment condition.

Behavioral: Wait list

Interventions

video-based transdiagnostic REBT BEHAVIORAL

The video-based transdiagnostic REBT consists of 6 sessions delivered in a group format.

video-based transdiagnostic REBT

Wait list BEHAVIORAL

Delayed intervention

wait list

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, 400015, Romania

Location

Related Publications (1)

• Pasarelu CR, Dobrean A. A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents: study protocol of a cluster randomized controlled trial. BMC Psychiatry. 2018 Apr 13;18(1):101. doi: 10.1186/s12888-018-1684-0.

  PMID: 29653523 DERIVED

MeSH Terms

Conditions

Panic Disorder; Phobia, Specific; Generalized Anxiety Disorder; Anxiety Disorders; Depression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Anca Dobrean, Ph.D.

  Babes-Bolyai University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 29, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be shared upon reasonable request after the publication of the manuscripts resulting from this study.
• Access Criteria: Data will be requested from the corresponding author of the resulting papers.

Locations

RO (1)