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Youth First: A Longitudinal Impact Evaluation

28 juillet 2021 mis à jour par: CorStone

Long-term Evaluation of the Effects of Youth First on Social and Emotional Development, Gender Equity, and Health of Adolescents in Rural Bihar, India

This trial will assess the effect of school-based emotional resilience and health curriculum, called Youth First, on middle school students who receive the curriculum in 7th and 8th grades. Key psychosocial wellbeing, mental health, educational wellbeing and substance use measures, will be assessed longitudinally over a three year period using a cluster randomized control design.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

This protocol is designed to answer key questions about the effects of Youth First on mental and sexual reproductive health, educational wellbeing and substance use. A mixed-methods, cluster randomized trial will assess the impact of the Youth First program over time. This component of the Youth First impact evaluation will take place across 70 schools (40 schools that are new to the Youth First intervention, 30 control schools) with 7th and 8th Standard students located within two districts in the state of Bihar, India, specifically Patna and Darbhanga.

This study will follow two cohorts of students: one of 8th Standard students and the other 7th Standard. This will include surveys conducted at baseline and at three follow-up time periods across a period of 32 months post-baseline (follow-up data collection at 8 (T1), 20 (T2), 32 (T3) months) to determine the short and long-term impact and additive effects of multiple years of Youth First. Eighth standard students will be followed through the end of 10th standard; the 7th standard cohort will be followed through the end of 9th. Both students who stay in school and those who leave will be followed up.

Quantitative data will be collected from 7th Standard (n=4500) and 8th Standard (n=3690) boys and girls across 100 schools in the two sub-studies, for a total study population of N=8190 students. Monitoring data from schools (e.g. number of sessions implemented, adherence to curriculum, etc.) collected as part of program implementation will inform a process evaluation of program quality and fidelity. Qualitative data will be collected from students after the completion of the Youth First program at the end of 8th Standard and at the end of T3.

Findings from this program are expected to provide much-needed evidence about the long-term effects of programs to address the psychosocial needs of youths in India, as well as information on the scalability of such a program within the school setting. It is expected that the findings from this study will be used by policy makers to inform decision making around the implementation of Youth First or similar programs within the state of Bihar and nationwide.

Type d'étude

Interventionnel

Inscription (Réel)

7762

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Inde
      • New Delhi, Inde
        • CorStone India Foundation

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • All students enrolled in 7th or 8th grades at one of the schools selected for the study.

School Selection Criteria are:

  • Government-run schools classified as rural and located in Darbhanga or Patna districts
  • Have a minimum of 30 students enrolled in each of 7th and 8th Standards
  • Have a high level of commitment from the principal to implement Youth First in both 7th and 8th grades, including willingness to have their teachers attend the training sessions and take the time to carry out the weekly sessions with the students.
  • Have a high level commitment from the teachers of 7th and 8th Standards to participate in Youth First sessions, which includes taking part in all 3 trainings and holding weekly Youth First sessions.
  • Have a physical space regularly available in which sessions could be held (relatively private and quiet, clean and uncluttered)
  • Have a regular student teacher ratio of 50:1 or below (based on data reported in U-DISE)
  • Accessible by a bus or taxi ride not greater than 3 hours from the nearest urban center.
  • Classified as rural school by the Bihar Education Program Council

Exclusion Criteria:

  • No exclusion criteria for students.

School exclusion criteria are:

  • Have experienced a delay in starting the school year in AY2017/18.
  • Have experienced extensive flooding in AY2017/18.
  • Currently implementing a similar emotional resilience or life skills program in the middle school levels.
  • Located in Naxal-affected area

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Youth First Curriculum

The full Youth First curriculum provides holistic training of both emotional resilience and adolescent health concepts. The curriculum is comprised of a 15-session emotional resilience curriculum and a 10-session adolescent health program. The resilience curriculum aims to increase both internal assets (such as self-esteem, coping skills, health knowledge, and conflict-resolution skills) and external assets (such as positive bonds with peers and family).

The adolescent health curriculum provides in-depth training in physical health and wellness topics such as sexual and reproductive health, common diseases, nutrition, gender equality, and substance use.

The curriculum is imparted by school teachers are trained and certified by CorStone.
Autre: Youth First Curriculum
A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.
Autres noms:
  • School-based emotional resilience and health curriculum
Aucune intervention: School as usual
This arm is comprised of students attending school as usual and receiving the established government-designed curriculum.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of student reporting being enrolled and regularly attending school
Délai: 32 months
Participants are enrolled in a grade-appropriate school at the end of the study period
32 months
Substance use
Délai: 32 months
Self-reported use of tobacco, alcohol or drugs.
32 months
Mental health
Délai: 32 months

Strengths and Difficulties Questionnaire, internalizing problems subscale: Sum of 10 items, score range of 0-20, with lower score indicating better outcomes.

KIDSCREEN psychological wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
32 months
Physical Health
Délai: 32 months
KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
32 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Gender equitable attitudes
Délai: 8, 20 and 32 months
Global Early Adolescent gender equity measure
8, 20 and 32 months
Emotional Resilience
Délai: 8, 20 and 32 months
Connor-Davidson Resilience measure: measure of emotional resilience. Sum of 10 items. Scale range from 0-40. Higher score indicates better outcomes.
8, 20 and 32 months
Self-efficacy
Délai: 8, 20 and 32 months
Schwarzer's Self-Efficacy Scale: Sum of 10 items. Scale range from 0-40. Higher score indicates better outcome.
8, 20 and 32 months
Social Wellbeing
Délai: 8, 20 and 32 months
KIDSCREEN Social Wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
8, 20 and 32 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

CorStone

Collaborateurs

David and Lucile Packard Foundation

Les enquêteurs

  • Chercheur principal: Catherine Elkins, PhD, CorStone

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 mai 2018

Achèvement primaire (Anticipé)

1 août 2021

Achèvement de l'étude (Anticipé)

1 décembre 2021

Dates d'inscription aux études

Première soumission

10 octobre 2018

Première soumission répondant aux critères de contrôle qualité

10 octobre 2018

Première publication (Réel)

15 octobre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 août 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 01-YF-IN-2018-V1

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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