Mental Health Wellness 1 Clinical Trial
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
Verified date | July 2021 |
Source | CorStone |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 7762 |
Est. completion date | December 2021 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | CorStone India Foundation | New Delhi |
Lead Sponsor | Collaborator |
---|---|
CorStone | David and Lucile Packard Foundation |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of student reporting being enrolled and regularly attending school | Participants are enrolled in a grade-appropriate school at the end of the study period | 32 months | |
Primary | Substance use | Self-reported use of tobacco, alcohol or drugs. | 32 months | |
Primary | Mental health | 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 | |
Primary | Physical Health | KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes. | 32 months | |
Secondary | Gender equitable attitudes | Global Early Adolescent gender equity measure | 8, 20 and 32 months | |
Secondary | Emotional Resilience | 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 | |
Secondary | Self-efficacy | Schwarzer's Self-Efficacy Scale: Sum of 10 items. Scale range from 0-40. Higher score indicates better outcome. | 8, 20 and 32 months | |
Secondary | Social Wellbeing | KIDSCREEN Social Wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes. | 8, 20 and 32 months |
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