Well-BeingNCT04020549
Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents
A study testing Growth, Gratitude, & Positive Activities in people with Well-Being and Depression, run by University of Pennsylvania at 1 site in India.
Trial summary
The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents attending a rural, low-resource government school. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Depression, Anxiety
- What is being tested?
- Growth, Gratitude, & Positive Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 31 Jul 2019to 31 Aug 2019
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Attending a participating secondary school
- Age 12 to 18
- Literate in English
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of a Computerized, School-Based, Single-Session Intervention for Rural Indian Adolescents
The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents attending a rural, low-resource government school. The investigators will be examining the effects of a computerized intervention on the well-being and mental health of adolescents. The investigators hypothesize that the intervention will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.
- Conditions
- Well-Being, Depression, Anxiety
- Being tested
- Growth, Gratitude, & Positive Activities, Study Skills Control
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth, Gratitude, & Positive ActivitiesBehavioural
Reading and writing activities based on growth (designed to instill the belief that people can change), gratitude (noticing and appreciating good things in life), and behavioral activation (identifying and scheduling positive activities).
Study Skills ControlBehavioural
Reading and writing activities designed to teach evidence-based study strategies.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Growth, Gratitude, & Positive Activities |
| Study Skills Control | Sham comparator | Not described Receives: Behavioral: Study Skills Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Warwick-Edinburgh Mental Wellbeing Scale
Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.
Measured: Baseline, 4 week follow-up, 12 week follow-up
Intervention Appropriateness Measure
Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Measured: Immediately post-intervention (i.e., 0 weeks)
Secondary outcomes (6)
Patient Health Questionnaire-9
Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.
Measured: Baseline, 4 week follow-up, 12 week follow-up
Generalized Anxiety Disorder Screener-7
Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.
Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.
Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.
Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.
Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.
Measured: Baseline, 4 week follow-up, 12 week follow-up
The EPOCH Measure of Adolescent Well-being
Questionnaire with five subscales measuring engagement, perseverance, optimism, connectedness, and happiness. Each subscale score ranges from 4 to 20. Higher scores indicate a better outcome. The happiness and optimism subscales will be used as secondary outcomes for this trial. A total score is not computed.
Measured: Baseline, 4 week follow-up, 12 week follow-up
Acceptability of Intervention Measure
Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Measured: Immediately post-intervention (i.e., 0 weeks)
Feasibility of Intervention Measure
Questionnaire measuring the feasibility of an intervention. Feasibility refers to the degree to which a treatment can be successfully implemented in a given setting. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Measured: Immediately post-intervention (i.e., 0 weeks)
Perceived Stress Scale-4
Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.
Measured: Time Frame: Baseline, 4 week follow-up, 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start31 Jul 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: In collaboration with community partners, we determined that the reading level required for the intervention did not make it suitable for the adolescents.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-BeingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Sangath
- Responsible party
- Sponsor
- Investigators
- Rob DeRubeis, PhD, Study director, University of PennsylvaniaSachin Shinde, PhD, Study director, SangathSadhana Natu, PhD, Study director, Modern College PuneAkash Wasil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020549
- Sponsor's protocol ID
- 30927492
- Status last verified
- Jun 2020
- First submitted
- 12 Jul 2019
- Last updated
- 30 Jun 2020
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Computerized, School-Based, Single-Session Intervention for Rural Indian Adolescents
- ClinicalTrials.gov ID
- NCT04020549
- Acronym / sponsor ID
- 30927492
- Conditions
- Well-Being, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In collaboration with community partners, we determined that the reading level required for the intervention did not make it suitable for the adolescents.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Sangath
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 16 Jul 2019 (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.
The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents attending a rural, low-resource government school. The investigators will be examining the effects of a computerized intervention on the well-being and mental health of adolescents. The investigators hypothesize that the intervention will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Growth, Gratitude, & Positive Activities |
| Study Skills Control | Sham comparator | Behavioral: Study Skills Control |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Attending a participating secondary school
- Age 12 to 18
- Literate in English
Key exclusion criteria (1 listed)
- Unable to provide informed consent
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 |
|---|---|---|
| Growth, Gratitude, & Positive ActivitiesReading and writing activities based on growth (designed to instill the belief that people can change), gratitude (noticing and appreciating good things in life), and behavioral activation (identifying and scheduling positive activities). | Behavioural | Intervention |
| Study Skills ControlReading and writing activities designed to teach evidence-based study strategies. | Behavioural | Study Skills Control |
Primary outcome
Change in The Warwick-Edinburgh Mental Wellbeing Scale
Time frame: Baseline, 4 week follow-up, 12 week follow-up
Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.
Intervention Appropriateness Measure
Time frame: Immediately post-intervention (i.e., 0 weeks)
Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
6 secondary outcomes
Patient Health Questionnaire-9
Time frame: Baseline, 4 week follow-up, 12 week follow-up
Generalized Anxiety Disorder Screener-7
Time frame: Baseline, 4 week follow-up, 12 week follow-up
The EPOCH Measure of Adolescent Well-being
Time frame: Baseline, 4 week follow-up, 12 week follow-up
Acceptability of Intervention Measure
Time frame: Immediately post-intervention (i.e., 0 weeks)
Feasibility of Intervention Measure
Time frame: Immediately post-intervention (i.e., 0 weeks)
Perceived Stress Scale-4
Time frame: Time Frame: Baseline, 4 week follow-up, 12 week follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Well-Being
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
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.
Rob DeRubeis, PhD study director
University of Pennsylvania
Sachin Shinde, PhD study director
Sangath
Sadhana Natu, PhD study director
Modern College Pune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth, Gratitude, & Positive Activities in people with Well-Being and Depression, run by University of Pennsylvania 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 30 Jun 2020. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in The Warwick-Edinburgh Mental Wellbeing Scale (time frame: Baseline, 4 week follow-up, 12 week follow-up). The study lists 2 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 30 Jun 2020.