- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Elâzığ, 터키 (Türkiye), 23119
- Fırat University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Perceived Self-Regulation Scale Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Middle School Academic Achievement Test Score
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- WAY-RCT-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .