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Completed

NCT Number: NCT03982563

Computerized Single-Session Interventions for Indian Adolescents

The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents. The investigators will be examining the effects of three interventions on the well-being and mental health of adolescents. The investigators hypothesize that at least one of the three interventions will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.

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Key information

Conditions

Well-Being Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Kalmadi Junior High School, Pune, Maharashtra, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to provide informed consent

Treatment and study plan

Growth Mindset

Behavioral

Reading and writing activities designed to instill the belief that people can change.

Gratitude

Behavioral

Reading and writing activities designed to practice noticing and appreciating good things in life.

Behavioral Activation

Behavioral

Reading and writing activities designed to identify and schedule positive activities.

Study Skills

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Patient Health Questionnaire-9

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

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

  2. Generalized Anxiety Disorder Screener-7

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

    Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.

  3. The EPOCH Measure of Adolescent Well-being

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

    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.

  4. Acceptability of Intervention Measure

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

    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.

  5. Feasibility of Intervention Measure

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

    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.

  6. Perceived Stress Scale-4

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

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Sangath

Registry information

Official study title

Evaluating the Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2019
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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