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Computerized Single-Session Interventions for Indian Adolescents

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ClinicalTrials.gov Identifier: NCT03982563
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Sangath
Information provided by (Responsible Party):
Akash Wasil, University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Well-being Depression Anxiety Behavioral: Growth Mindset Behavioral: Gratitude Behavioral: Behavioral Activation Behavioral: Study Skills Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating the Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Growth Mindset Behavioral: Growth Mindset
Reading and writing activities designed to instill the belief that people can change.

Experimental: Gratitude Behavioral: Gratitude
Reading and writing activities designed to practice noticing and appreciating good things in life.

Experimental: Behavioral Activation Behavioral: Behavioral Activation
Reading and writing activities designed to identify and schedule positive activities.

Sham Comparator: Study Skills Behavioral: Study Skills
Reading and writing activities designed to learn evidence-based study strategies.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982563


Contacts
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Contact: Akash Wasil 6317669466 akashwasil133@gmail.com

Locations
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India
Modern College Pune Not yet recruiting
Pune, India
Contact: Sadhana Natu         
Sponsors and Collaborators
University of Pennsylvania
Sangath
Investigators
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Study Director: Rob DeRubeis, PhD University of Pennsylvania
Study Director: Sachin Shinde, PhD Sangath
Study Director: Sadhana Natu, PhD Modern College Pune
Principal Investigator: Akash Wasil University of Pennsylvania