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Youth First: A Longitudinal Impact Evaluation

28 juli 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

7762

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Indië
      • New Delhi, Indië
        • CorStone India Foundation

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Youth First Curriculum
A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.
Andere namen:
  • School-based emotional resilience and health curriculum
Geen tussenkomst: School as usual
This arm is comprised of students attending school as usual and receiving the established government-designed curriculum.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of student reporting being enrolled and regularly attending school
Tijdsspanne: 32 months
Participants are enrolled in a grade-appropriate school at the end of the study period
32 months
Substance use
Tijdsspanne: 32 months
Self-reported use of tobacco, alcohol or drugs.
32 months
Mental health
Tijdsspanne: 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
Tijdsspanne: 32 months
KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
32 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gender equitable attitudes
Tijdsspanne: 8, 20 and 32 months
Global Early Adolescent gender equity measure
8, 20 and 32 months
Emotional Resilience
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

CorStone

Medewerkers

David and Lucile Packard Foundation

Onderzoekers

  • Hoofdonderzoeker: Catherine Elkins, PhD, CorStone

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 mei 2018

Primaire voltooiing (Verwacht)

1 augustus 2021

Studie voltooiing (Verwacht)

1 december 2021

Studieregistratiedata

Eerst ingediend

10 oktober 2018

Eerst ingediend dat voldeed aan de QC-criteria

10 oktober 2018

Eerst geplaatst (Werkelijk)

15 oktober 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

28 juli 2021

Laatst geverifieerd

1 juli 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 01-YF-IN-2018-V1

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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 .

Klinische onderzoeken op Geestelijke gezondheid Welzijn 1

Klinische onderzoeken op Youth First Curriculum

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