- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07935486
Evaluating a School-based Mental Health Program on Self-esteem, Stress, and Anxiety Among Adolescent Girls in Yemen.
Educational Program on Self-Esteem, Stress and Anxiety Among Adolescent Girls in Public Schools in Sana'a, Yemen: A Controlled Trial
The goal of this interventional study was to learn if a mental health educational program can improve self-esteem and reduce stress and anxiety in school girls in Sana'a, Yemen.
The main question aims to answer:
Is there a significant difference in self-esteem, stress, and anxiety outcomes between the intervention group participating in the mental health educational program and the control group?
Participants will:
Complete self-reported questionnaires assessing self-esteem (RSES), stress (PSS-10), and anxiety (GAD-7) at baseline pre-test, immediate post-intervention post-test, and 3 months follow up post-test.
Attend interactive 5-days psychoeducational program sessions delivered within their school setting (intervention school), and 5-days placebo program for (control school).
연구 개요
상태
상세 설명
The trial incorporates two schools: an Intervention and an Active Control conducted in two public schools in Sana'a city and was randomly assigned to either an intervention arm or a control arm. The study was conducted in these phases:
- Pre-test phase (before intervention): Both school's participants completed self-administration questionnaires to assess baseline levels of self-esteem, stress and anxiety.
- Intervention phase: Two programs were facilitated by the researcher at each target school. A 5-day interventional mental health educational program (Understanding the self, Emotional resilience, Cognitive awareness, Psychosocial self-care and integration and empowerment) 2 to 3 hours per day, for the intervention group (Juwayriyah Bint Al-Harith School) and a 5-day general health program (Personal hygiene, Health emergencies, Cholera awareness, Healthy boundaries and Health systems), 2 to 3 hours per day, for the control group (Ibn Seena School). One teacher assigned from each school administration helped the researcher by providing logistical support while the researcher facilitated the sessions. Each student was gifted a booklet that summarized the program they participated in.
- First post-test phase (at the end of fifth day): After completing both programs for each school, both groups re-took the same questionnaire to measure changes in the intervention group compared to the control group.
- Three month follow up phase: Simple follow-up was conducted by the assigned teachers by handing girls a printed paper designed by the researcher that had simple questions and activities about related programs for each school. The participants were encouraged to follow the instructions once a week by the assigned teacher.
- Second post-test phase: Three months after the programs and follow up, both groups re-took the same self-administrated questionnaire for the third time to measure the effectiveness of the mental health educational program in the longer term.
The intervention school participated in 5-days "Mental health educational program" 2 to 3 hours per day. The program was delivered with lecture-based PowerPoints, interactive activities and role plays, emotional expression exercises, repetition of empowering messages, storytelling, visualization and Islamic integration, breathing and other techniques.
The entire program was developed by the researcher based on a comprehensive review of international and local frameworks and manuals from the WHO (Mental Health in Schools: Manual) (WHO, 2021), UNICEF (Helping Adolescents Thrive Toolkit) (UNICEF, 2022) and (National Community-Based Mental Health and Psychosocial Support Guideline) (MoPHP, 2021) along with peer-review from diverse school interventions in several settings that were taken as structural inspiration. However, the program was independently developed and adapted for the targeted participants.
On the other hand, the control school participated in a 5-day general health program -non mental-(Personal hygiene, Health emergencies, Cholera awareness, Healthy boundaries and Health systems), 2 to 3 hours per day. Similar to the intervention program, the supporting materials of the program were customized simple Arabic PowerPoint presentations, illustration posters and cards, daily blank papers for the girls to do activities given and a booklet (summary of the program subjects) as a gift at the end of the program.
The results were compared between the two groups to evaluate the effectiveness of the "mental health educational program" on self-esteem, stress, and Anxiety.
This study was conducted in two girls' public schools in Sana'a Yemen (Al Sabeen District). The schools selected for the study were Juwayriyah Bint Al-Harith and Ibn Seena Schools. Juwayriyah Bint Al-Harith school was the intervention School and Ibn Seena school was the control group. This was assigned in a simple random selection.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Al-Sabeen District
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Sanaa, Al-Sabeen District, 예멘, 00000
- Al-Razi University and Schools in Al-Sabeen District
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
The inclusion criteria for both intervention and control group were:
- Adolescent girls aged (12-18) studying in Juwayriyah Bint Al-Harith School and Ibn Seena School in Sana'a Yemen.
- Students without any attendance issues to ensure attendance and completion of the programs.
- Students from middle and secondary school classes.
- Students who agreed to enroll and provided signed approval from their parents to participate in the study.
Exclusion Criteria:
The exclusion criteria for both Intervention and control group were:
- Students who didn't fulfill the inclusion criteria.
- Drop outs: Students who didn't attend the entire program (more than 1 day absent)
- Students who didn't take the three tests (pre-test, immediate posttest or three-month post-test)
- The student who did not provide parental consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention arm
Participants receive the school-based Mental Health Educational Program designed to improve self-esteem and reduce stress and anxiety. |
A structured school-based 5-days, 2 to 3 hours per day, mental health educational program designed to enhance self-esteem and reduce stress and anxiety among female students. The program was delivered with lecture-based PowerPoints, interactive activities and role plays, emotional expression exercises, repetition of empowering messages, storytelling, visualization and Islamic integration, breathing and other techniques.
다른 이름들:
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위약 비교기: Control Arm
Participants receive a general health education program unrelated to psychological or mental health, serving as an placebo program. |
A 5-day general health program (Personal hygiene, Health emergencies, Cholera awareness, Healthy boundaries and Health systems), 2 to 3 hours per day, for the control group. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Self-Esteem Score
기간: Baseline and immediately post-intervention (at the end of the intervention period) and 3 months after intervention. From September 2025 until January 2026.
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Assessed using the Rosenberg Self-Esteem Scale (RSES). Scores range from 0 to 30, with higher scores indicating higher self-esteem. |
Baseline and immediately post-intervention (at the end of the intervention period) and 3 months after intervention. From September 2025 until January 2026.
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Change in Perceived Stress Score
기간: Baseline and immediately post-intervention (at the end of the intervention period) and 3 months after intervention. From September 2025 until January 2026.
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Assessed using the Perceived Stress Scale (PSS-10). Scores range from 0 to 40, with higher scores indicating higher perceived stress levels. |
Baseline and immediately post-intervention (at the end of the intervention period) and 3 months after intervention. From September 2025 until January 2026.
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Change in Generalized Anxiety Score
기간: Baseline and immediately post-intervention (at the end of the intervention period) and 3 months after intervention. From September 2025 until January 2026.
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Assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Scores range from 0 to 21, with higher scores indicating higher anxiety severity. |
Baseline and immediately post-intervention (at the end of the intervention period) and 3 months after intervention. From September 2025 until January 2026.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Yahia Ahmed Raja'a, Professor in Public Health, Al-Razi University, Sana'a University.
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
- RU/21/FMSH/2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified participant data that do not compromise participant confidentiality or privacy may be made available or shared with qualified reasearchers for scientific research purposes upon reasonable request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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