Clinical trial NCT02756507: 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
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Major Depression Mild
Panic Disorder
Specific Phobia
Generalized Anxiety Disorder
Keywords: anxiety symptoms
depression symptoms
internalizing symptoms
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 381
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The Multidimensional Anxiety Scale for Children (MASC; March, Parker, Sullivan, Stallings, & Conners, 1997)
timeFrame: Change from baseline anxiety symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
measure: Beck Depression Inventory for Youth subscale from the Beck Youth Inventories-Second edition for children and adolescents (Beck, 2005)
timeFrame: Change from baseline depressive symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
Secondary outcomes:
measure: The Children's Automatic Thoughts Scale - Negative/Positive (CATS-N/P) (Hogendoorn et al., 2010)
timeFrame: Change from baseline maladaptive cognitions at 3 weeks post-intervention, 3 month follow up, 12 months follow-up
measure: The Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997)
timeFrame: Change from baseline comorbid problems at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
measure: 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)
timeFrame: Change from baseline quality of life at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
measure: The Credibility/ Expectancy Questionnaire (Devilly & Borkovec, 2000)
timeFrame: pre-intervention
measure: The Client Satisfaction Scale (Vigerland et al., 2016)
timeFrame: post-intervention
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
affiliation: Babes-Bolyai University
name: Anca Dobrean, Ph.D.
role: STUDY_DIRECTOR
References:
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.