- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02756507
Transdiagnostic REBT Prevention Program for Adolescents
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cluj-Napoca, Romania, 400015
- Babes-Bolyai University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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 |
|---|---|
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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.
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The video-based transdiagnostic REBT consists of 6 sessions delivered in a group format.
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SHAM_COMPARATOR: wait list
The wait-list is a delayed treatment condition.
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Delayed intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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anxiety symptoms
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Change from baseline anxiety symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
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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
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depressive symptoms
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Change from baseline depressive symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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maladaptive cognitions
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Change from baseline maladaptive cognitions at 3 weeks post-intervention, 3 month follow up, 12 months follow-up
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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
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comorbid problems
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Change from baseline comorbid problems at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
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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
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quality of life
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Change from baseline quality of life at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
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The Credibility/ Expectancy Questionnaire (Devilly & Borkovec, 2000)
Time Frame: pre-intervention
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Treatment expectancies
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pre-intervention
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The Client Satisfaction Scale (Vigerland et al., 2016)
Time Frame: post-intervention
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Satisfaction with the intervention
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post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Anca Dobrean, Ph.D., Babes-Bolyai University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
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