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
|Condition or disease||Intervention/treatment||Phase|
|Resilience, Psychological Mental Health Wellness 1||Other: Youth First Curriculum||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8200 participants|
|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.|
|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|
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.
- 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
- Substance use [ Time Frame: 32 months ]Self-reported use of tobacco, alcohol or drugs.
- 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.
- 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.
- Gender equitable attitudes [ Time Frame: 8, 20 and 32 months ]Global Early Adolescent gender equity measure
- 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.
- 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.
- 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.
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
|Contact: Lisa M DeMaria, DrPHfirstname.lastname@example.org|
|Contact: Kate Leventhal, BAemail@example.com|
|CorStone India Foundation||Recruiting|
|New Delhi, India|
|Contact: Gracy Andrew, MS +918527209021 firstname.lastname@example.org|
|Principal Investigator:||Lisa M DeMaria, DrPH||CorStone|