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Youth First: A Longitudinal Impact Evaluation

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ClinicalTrials.gov Identifier: NCT03705208
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
David and Lucile Packard Foundation
Information provided by (Responsible Party):
CorStone

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Resilience, Psychological Mental Health Wellness 1 Other: Youth First Curriculum Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The technical advisory group constituted for this study will be presented masked results, wherein the results will be presented without identifying the study arm.
Primary Purpose: Prevention
Official Title: Long-term Evaluation of the Effects of Youth First on Social and Emotional Development, Gender Equity, and Health of Adolescents in Rural Bihar, India
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: 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.

Other: Youth First Curriculum
A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.
Other Name: School-based emotional resilience and health curriculum

No Intervention: School as usual
This arm is comprised of students attending school as usual and receiving the established government-designed curriculum.



Primary Outcome Measures :
  1. Number of student reporting being enrolled and regularly attending school [ Time Frame: 32 months ]
    Participants are enrolled in a grade-appropriate school at the end of the study period

  2. Substance use [ Time Frame: 32 months ]
    Self-reported use of tobacco, alcohol or drugs.

  3. Mental health [ Time Frame: 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.


  4. Physical Health [ Time Frame: 32 months ]
    KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.


Secondary Outcome Measures :
  1. Gender equitable attitudes [ Time Frame: 8, 20 and 32 months ]
    Global Early Adolescent gender equity measure

  2. Emotional Resilience [ Time Frame: 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.

  3. Self-efficacy [ Time Frame: 8, 20 and 32 months ]
    Schwarzer's Self-Efficacy Scale: Sum of 10 items. Scale range from 0-40. Higher score indicates better outcome.

  4. Social Wellbeing [ Time Frame: 8, 20 and 32 months ]
    KIDSCREEN Social Wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705208


Contacts
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Contact: Lisa M DeMaria, DrPH +1415.272.5160 lisad@gmail.com
Contact: Kate Leventhal, BA +1410.952.8819 kates@corstone.org

Locations
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India
CorStone India Foundation Recruiting
New Delhi, India
Contact: Gracy Andrew, MS    +918527209021    gracya@corstone.org   
Sponsors and Collaborators
CorStone
David and Lucile Packard Foundation
Investigators
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Principal Investigator: Lisa M DeMaria, DrPH CorStone

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Responsible Party: CorStone
ClinicalTrials.gov Identifier: NCT03705208     History of Changes
Other Study ID Numbers: 01-YF-IN-2018-V1
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Requests from IPD from other researchers will be considered. No data will be shared prior to 6 months post-completion of the final round of data collection. Before sharing a detailed protocol and analysis plan from the researcher requesting the data will be required. All data will be stripped of any student or school identifying information prior to being shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No