Resilience, PsychologicalNCT03705208
Youth First: A Longitudinal Impact Evaluation
A study testing Youth First Curriculum in people with Resilience, Psychological and Mental Health Wellness 1, run by CorStone at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Psychological, Mental Health Wellness 1
- What is being tested?
- Youth First Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,762 participants
- Where
- 1 siteIndia
- Study dates
- 8 May 2018to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Youth First Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth First CurriculumOther
Also called School-based emotional resilience and health curriculum
A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.
| Study group | Role | What they receive |
|---|---|---|
| Youth First Curriculum | Experimental | 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. Receives: Other: Youth First Curriculum |
| School as usual | No intervention | This arm is comprised of students attending school as usual and receiving the established government-designed curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 32 months
Substance use
Self-reported use of tobacco, alcohol or drugs.
Measured: 32 months
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.
Measured: 32 months
Physical Health
KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
Measured: 32 months
Secondary outcomes (4)
Gender equitable attitudes
Global Early Adolescent gender equity measure
Measured: 8, 20 and 32 months
Emotional Resilience
Connor-Davidson Resilience measure: measure of emotional resilience. Sum of 10 items. Scale range from 0-40. Higher score indicates better outcomes.
Measured: 8, 20 and 32 months
Self-efficacy
Schwarzer's Self-Efficacy Scale: Sum of 10 items. Scale range from 0-40. Higher score indicates better outcome.
Measured: 8, 20 and 32 months
Social Wellbeing
KIDSCREEN Social Wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
Measured: 8, 20 and 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start8 May 2018
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resilience, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,762 participants (actual)
Sponsor and investigators
- Lead sponsor
- CorStone
- Sponsor type
- University, hospital or other
- Collaborators
- David and Lucile Packard Foundation
- Responsible party
- Sponsor
- Investigators
- Catherine Elkins, PhD, Principal investigator, CorStone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705208
- Sponsor's protocol ID
- 01-YF-IN-2018-V1
- Status last verified
- Jul 2021
- First submitted
- 10 Oct 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03705208
- Acronym / sponsor ID
- 01-YF-IN-2018-V1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,762 participants (actual)
- Lead sponsor
- CorStoneUniversity, hospital or other
- Collaborators
- David and Lucile Packard Foundation
- Study start
- 8 May 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Youth First Curriculum | Experimental | Other: Youth First CurriculumThe 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. |
| School as usual | No intervention | –This arm is comprised of students attending school as usual and receiving the established government-designed curriculum. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- All students enrolled in 7th or 8th grades at one of the schools selected for the study.
- 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.
Key exclusion criteria (6 listed)
- No exclusion criteria for students.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youth First CurriculumAlso: School-based emotional resilience and health curriculumA 25 session emotional resilience and health curriculum designed for 7th and 8th grade students. | Other | Youth First Curriculum |
Primary outcome
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.
4 secondary outcomes
Gender equitable attitudes
Time frame: 8, 20 and 32 months
Emotional Resilience
Time frame: 8, 20 and 32 months
Self-efficacy
Time frame: 8, 20 and 32 months
Social Wellbeing
Time frame: 8, 20 and 32 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Elkins, PhD principal investigator
CorStone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth First Curriculum in people with Resilience, Psychological and Mental Health Wellness 1, run by CorStone at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of student reporting being enrolled and regularly attending school (time frame: 32 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.