ClinicalTrials.gg
WithdrawnNCT04020549Updated Jun 30, 2020

Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents

An interventional study of Growth, Gratitude, & Positive Activities and Study Skills Control in Well-Being, Depression and Anxiety, sponsored by University of Pennsylvania. Withdrawn at 1 site in India. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

Why this study was withdrawn
In collaboration with community partners, we determined that the reading level required for the intervention did not make it suitable for the adolescents.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Well-Being
  • Depression
  • Anxiety
03

In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

Browse Depression studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Attending a participating secondary school
  • Age 12 to 18
  • Literate in English

Exclusion criteria

Exclusion Criteria:

  • Unable to provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention

    Behavioral: Growth, Gratitude, & Positive Activities

  • Sham comparator
    Study Skills Control

    Behavioral: Study Skills Control

Interventions

  • BehavioralGrowth, Gratitude, & Positive Activities

    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).

  • BehavioralStudy Skills Control

    Reading and writing activities designed to teach evidence-based study strategies.

06

What researchers measure

Primary outcomes

  1. Change in The Warwick-Edinburgh Mental Wellbeing Scale

    Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.

    Time frame: Baseline, 4 week follow-up, 12 week follow-up

  2. 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.

    Time frame: Immediately post-intervention (i.e., 0 weeks)

Secondary outcomes

  1. Patient Health Questionnaire-9

    Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.

    Time frame: Baseline, 4 week follow-up, 12 week follow-up

  2. 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.

    Time frame: Baseline, 4 week follow-up, 12 week follow-up

  3. 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.

    Time frame: Baseline, 4 week follow-up, 12 week follow-up

  4. 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.

    Time frame: Immediately post-intervention (i.e., 0 weeks)

  5. 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.

    Time frame: Immediately post-intervention (i.e., 0 weeks)

  6. Perceived Stress Scale-4

    Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.

    Time frame: Time Frame: Baseline, 4 week follow-up, 12 week follow-up

07

Study locations

1 site
  • Z P school, Wablewadi
    Pune, Maharashtra, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in Aug 2019, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2019
First posted
Jul 16, 2019
StartActual
Jul 31, 2019
Primary completionActual
Aug 31, 2019
CompletionActual
Aug 31, 2019
Last update
Jun 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04020549
Collaborators
Sangath
Responsible party
Sponsor
First posted
Jul 16, 2019
Start date
Jul 31, 2019
Primary completion
Aug 31, 2019
Completion
Aug 31, 2019
Last update
Jun 30, 2020

Study contacts

Rob DeRubeis, PhD
study director · University of Pennsylvania
Sachin Shinde, PhD
study director · Sangath
Sadhana Natu, PhD
study director · Modern College Pune
Akash Wasil
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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