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Table 2 WHO Trial Registration Data Set

From: A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents: study protocol of a cluster randomized controlled trial

Data category Information
Primary registry and trial identifying number ClinicalTrials.gov NCT02756507
Date of registration in primary registry 25 April 2015
Secondary identifying numbers The Ethics Committee of Babeș-Bolyai University (Registration number: 33215/ 03.06.2016)
Sources of monetary or material support The Romanian Executive Unit for Financing Education Higher Research, Development and Innovation, Babeș-Bolyai University
Primary sponsor Babeș-Bolyai University
Contact for public queries Costina Ruxandra Păsărelu
Department of Clinical Psychology and Psychotherapy
Babeș-Bolyai University
Romania
Republicii St., No. 37
Postal code: 400015
E-mail: costina.pasarelu@ubbcluj.ro
Contact for scientific queries Prof. Anca Dobrean
Babeș-Bolyai University
Republicii St., No. 37
Postal code: 400015
E-mail: anca.dobrean@ubbcluj.ro
Public title Transdiagnostic REBT Prevention Program for Adolescents
Scientific title A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents
Countries of recruitment Romania
Health condition(s) or problem(s) studied Anxiety
Depression
Internalizing problems
Intervention(s) Experimental: video-based transdiagnostic REBT prevention program
Control: waiting list
Key inclusion and exclusion 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 12 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 type Randomized controlled trial
Date of first enrollment June 2016
Target sample size 338
Recruitment status Recruiting
Primary outcome(s) Anxiety symptoms at T2, T3, T4; the Multidimensional Anxiety Scale for Children
Depressive symptoms at T2, T3, T4; the Beck Youth Inventories™ -Second Edition for Children and Adolescents
Key secondary outcome(s) Maladaptive cognitions at T2, T3, T4; the Children’s Automatic Thoughts Scale – Negative/Positive
Comorbid problems at T2, T3, T4; the Strengths and Difficulties Questionnaire
Prosocial behaviors
Quality of life at T2, T3, T4; the Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, The Revised Version – adolescent version
Treatment expectancies at T2; the Credibility/ Expectancy Questionnaire
Satisfaction with the intervention at T2; the Client Satisfaction Scale