Transdiagnostic REBT Prevention Program for Adolescents

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756507
• Other study ID #: PN-II-PT-PCCA-2011-3.1-1500
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: February 2023
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Disease
• Generalized Anxiety Disorder
• Major Depression Mild
• Panic Disorder
• Social Anxiety
• Specific Phobia

Intervention

Behavioral:
• video-based transdiagnostic REBT
The video-based transdiagnostic REBT consists of 6 sessions delivered in a group format.
• Wait list
Delayed intervention

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The Children's Automatic Thoughts Scale - Negative/Positive (CATS-N/P) (Hogendoorn et al., 2010)	maladaptive cognitions	Change from baseline maladaptive cognitions at 3 weeks post-intervention, 3 month follow up, 12 months follow-up
Secondary	The Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997)	comorbid problems	Change from baseline comorbid problems at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
Secondary	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	Change from baseline quality of life at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
Secondary	The Credibility/ Expectancy Questionnaire (Devilly & Borkovec, 2000)	Treatment expectancies	pre-intervention
Secondary	The Client Satisfaction Scale (Vigerland et al., 2016)	Satisfaction with the intervention	post-intervention