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Transdiagnostic REBT Prevention Program for Adolescents

Primary Purpose

Social Anxiety, Major Depression Mild, Panic Disorder

Status

Completed

Phase

Not Applicable

Locations

Romania

Study Type

Interventional

Intervention

video-based transdiagnostic REBT

Wait list

About this trial

This is an interventional prevention trial for Social Anxiety focused on measuring anxiety symptoms, depression symptoms, internalizing symptoms

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Babes-Bolyai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

video-based transdiagnostic REBT

wait list

Arm Description

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.

The wait-list is a delayed treatment condition.

Outcomes

Primary Outcome Measures

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

anxiety symptoms

Beck Depression Inventory for Youth subscale from the Beck Youth Inventories-Second edition for children and adolescents (Beck, 2005)

depressive symptoms

Secondary Outcome Measures

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

maladaptive cognitions

The Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997)

comorbid problems

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)

quality of life

The Credibility/ Expectancy Questionnaire (Devilly & Borkovec, 2000)

Treatment expectancies

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

Satisfaction with the intervention

Full Information

NCT ID

NCT02756507

First Posted

April 25, 2016

Last Updated

February 7, 2023

Sponsor

Babes-Bolyai University

1. Study Identification

Unique Protocol Identification Number

NCT02756507

Brief Title

Transdiagnostic REBT Prevention Program for Adolescents

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Babes-Bolyai University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

anxiety symptoms, depression symptoms, internalizing symptoms

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

381 (Actual)

8. Arms, Groups, and Interventions

Arm Title

video-based transdiagnostic REBT

Arm Type

Experimental

Arm Description

Arm Title

wait list

Arm Type

Sham Comparator

Arm Description

The wait-list is a delayed treatment condition.

Intervention Type

Behavioral

Intervention Name(s)

video-based transdiagnostic REBT

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Wait list

Intervention Description

Delayed intervention

Primary Outcome Measure Information:

Title

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

Description

anxiety symptoms

Time Frame

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

Title

Beck Depression Inventory for Youth subscale from the Beck Youth Inventories-Second edition for children and adolescents (Beck, 2005)

Description

depressive symptoms

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

maladaptive cognitions

Time Frame

Change from baseline maladaptive cognitions at 3 weeks post-intervention, 3 month follow up, 12 months follow-up

Title

The Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997)

Description

comorbid problems

Time Frame

Change from baseline comorbid problems at 3 weeks post-intervention, 3 months follow up, 12 months follow-up

Title

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)

Description

quality of life

Time Frame

Change from baseline quality of life at 3 weeks post-intervention, 3 months follow up, 12 months follow-up

Title

The Credibility/ Expectancy Questionnaire (Devilly & Borkovec, 2000)

Description

Treatment expectancies

Time Frame

pre-intervention

Title

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

Description

Satisfaction with the intervention

Time Frame

post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anca Dobrean, Ph.D.

Organizational Affiliation

Babes-Bolyai University

Official's Role

Study Director

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

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.

Citations:

PubMed Identifier

29653523

Citation

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.

Results Reference

derived

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Transdiagnostic REBT Prevention Program for Adolescents

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