Skip to main content

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