- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07780864
Who Are You (WAY) Online Social and Emotional Learning Program for Adolescents (WAY)
A Randomized Controlled Trial of a Digital Social and Emotional Learning Program for Adolescents: Effects on Social-Emotional Functioning and Academic Achievement
This study evaluated the Who Are You (WAY) program, a 10-week online social and emotional learning program designed for adolescents. The program aims to help young people better understand and manage emotions, regulate their behavior, stay motivated in learning, cope with stress, and develop goal-directed skills.
A total of 120 adolescents took part in the study, including 60 middle-school students and 60 high-school students. Within each educational group, participants were randomly assigned either to the WAY program or to a waitlist group that continued with their usual education. The WAY program combined weekly one-to-one online sessions with structured independent learning activities.
Participants completed assessments before and after the 10-week period. The main outcomes were self-regulation, emotional intelligence, academic motivation, and perceived stress. Academic achievement was also assessed as a secondary educational outcome.
The study tested the hypothesis that adolescents assigned to the WAY program would show greater improvement in social-emotional functioning than adolescents assigned to the waitlist condition.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This was a two-arm, parallel-group, assessor-blinded, waitlist-controlled randomized trial conducted with two developmentally distinct educational cohorts in Türkiye. Middle-school and high-school participants were randomized separately within cohort in a 1:1 ratio to either the WAY intervention or a waitlist control condition.
WAY was a manualized, digitally supported social and emotional learning intervention delivered over 10 consecutive weeks. Each weekly module included an individual synchronous online session supplemented by structured asynchronous activities. The program addressed self-awareness, emotional understanding and regulation, academic motivation, goal setting, planning, self-monitoring, stress management, adaptive coping, empathy, communication, and maintenance of acquired skills.
Participants in the waitlist condition continued their usual education during the evaluation period and were offered access to the WAY program after completion of post-intervention assessments.
Baseline assessments were completed before randomization, and post-intervention assessments were administered within one week after completion of the intervention period. The four prespecified primary outcome domains were self-regulation, trait emotional intelligence, academic motivation, and perceived stress. Academic achievement was prespecified as a secondary educational outcome. Outcomes were evaluated separately within the middle-school and high-school cohorts.
The trial was completed before registration on ClinicalTrials.gov and is therefore being registered retrospectively.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Elâzığ, Turkije (Türkiye), 23119
- Fırat University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Enrollment in Grades 5-12.
- Sufficient proficiency in Turkish to understand the program content and complete the study measures.
- Reliable internet access and access to an appropriate digital device for participation in the online program.
- Ability to engage with the program and complete the study measures independently, with reasonable support where required.
- Written informed consent from a parent or legal guardian and written assent from the adolescent.
Exclusion Criteria:
- Concurrent participation in another structured social and emotional learning program.
- A cognitive, sensory, linguistic, or functional difficulty that prevented meaningful participation or independent completion of the study measures despite reasonable accommodations.
- An acute psychological crisis or serious risk requiring immediate professional assessment or clinical support.
- Failure to complete the baseline assessment or withdrawal before randomization.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: WAY Intervention
Participants assigned to this arm received the 10-week Who Are You (WAY) social and emotional learning program in addition to their usual education.
The program included one individual synchronous online session per week, followed by structured asynchronous learning activities.
Each weekly module comprised approximately 30 minutes of synchronous instruction and 15-20 minutes of asynchronous activities.
|
WAY is a manualized, digitally supported social and emotional learning program designed for adolescents.
It was delivered individually over 10 consecutive weeks.
Each weekly module combined a synchronous online session with structured asynchronous activities.
The program addressed self-awareness, emotional understanding and regulation, academic motivation, goal setting, planning, self-monitoring, stress management, adaptive coping, empathy, communication, collaborative problem solving, and maintenance of acquired skills.
Sessions used guided discussion, reflective questioning, experiential activities, structured exercises, individualized reflection, and goal setting.
|
|
Geen tussenkomst: Waitlist Control
Participants assigned to this arm continued their usual school education and did not receive WAY sessions, facilitator contact, or intervention materials during the 10-week evaluation period.
They were offered access to the WAY program after completion of the post-intervention assessment.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change From Baseline in Perceived Self-Regulation Scale Score
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Self-regulation in the middle-school cohort was assessed using the 16-item Perceived Self-Regulation Scale.
Items are rated on a 5-point Likert-type scale.
Total scores are calculated by summing item responses, with higher scores indicating greater perceived self-regulatory capacity.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
|
Change From Baseline in Self-Regulation Scale for Adolescents Score
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Self-regulation in the high-school cohort was assessed using the 11-item Self-Regulation Scale for Adolescents.
The scale assesses goal setting, planning, monitoring, emotional awareness, and behavioral control using a 5-point response format.
Higher total scores indicate greater self-regulatory competence.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
|
Change From Baseline in Trait Emotional Intelligence Questionnaire-Adolescent Short Form Score
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Trait emotional intelligence was assessed in both cohorts using the 15-item Trait Emotional Intelligence Questionnaire-Adolescent Short Form (TEIQue-ASF).
Items are rated on a 7-point scale.
Negatively worded items are reverse scored, and higher total scores indicate greater perceived emotional competence.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
|
Change From Baseline in Academic Motivation Scale Score in Middle-School Studen
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Academic motivation in the middle-school cohort was assessed using the 28-item Turkish adaptation of the Academic Motivation Scale.
Items are rated on a 7-point scale.
Total scores are calculated after appropriate reverse scoring, with higher scores indicating stronger academic motivation.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
|
Change From Baseline in Academic Motivation Scale Score in High-School Students
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Academic motivation in the high-school cohort was assessed using the 22-item Turkish Academic Motivation Scale.
Items assess intrinsic motivation, extrinsic motivation, and amotivation and are rated on a 7-point scale.
Higher total scores indicate stronger academic motivation after appropriate reverse scoring.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
|
Change From Baseline in Perceived Stress Scale for Children Score
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Perceived stress in the middle-school cohort was assessed using the 9-item Perceived Stress Scale for Children.
Items are rated on a 4-point frequency scale.
Total scores are calculated by summing item responses, with higher scores indicating greater perceived stress.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
|
Change From Baseline in Perceived Stress Scale
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Perceived stress in the high-school cohort was assessed using the 10-item Perceived Stress Scale (PSS-10).
Items are rated from 0 (Never) to 4 (Very often).
Positively worded items are reverse scored before calculating the total score, with higher scores indicating greater perceived stress.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change From Baseline in Middle School Academic Achievement Test Score
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Academic achievement in the middle-school cohort was assessed using the 75-item Middle School Academic Achievement Test (MS-AAT), covering Turkish language, social studies, mathematics, and science.
Items are scored 1 for a correct response and 0 for an incorrect or omitted response, with higher total scores indicating greater academic achievement.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
|
Change From Baseline in High School Academic Achievement Test Score
Tijdsspanne: Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Academic achievement in the high-school cohort was assessed using the 80-item High School Academic Achievement Test (HS-AAT), covering curriculum-based academic domains.
Items are scored 1 for a correct response and 0 for an incorrect or omitted response, with higher total scores indicating greater academic achievement.
|
Baseline and post-intervention, within 1 week after completion of the 10-week program
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- WAY-RCT-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .