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 |