Computerized Single-Session Interventions for Indian Adolescents

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982563
• Other study ID #: 24922
• Status: Completed
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: June 4, 2020

Study information

• Verified date: June 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 958
• Est. completion date: June 4, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Attending a participating secondary school

• Age 12 to 18

• Literate in English

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Anxiety
• Depression
• Well-being

Intervention

Behavioral:
• Growth Mindset
Reading and writing activities designed to instill the belief that people can change.
• Gratitude
Reading and writing activities designed to practice noticing and appreciating good things in life.
• Behavioral Activation
Reading and writing activities designed to identify and schedule positive activities.
• Study Skills
Reading and writing activities designed to learn evidence-based study strategies.

Locations

Country	Name	City	State
India	Dr. Kalmadi Junior High School	Pune	Maharashtra
India	Modern College Pune	Pune
India	The Orchid School	Pune	Maharashtra
India	JM Rathi English School	Roha	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Sangath

Country where clinical trial is conducted

India, 

References & Publications (4)

Chorpita BF, Becker KD, Daleiden EL. Understanding the common elements of evidence-based practice: misconceptions and clinical examples. J Am Acad Child Adolesc Psychiatry. 2007 May;46(5):647-52. — View Citation

Emmons RA, McCullough ME. Counting blessings versus burdens: an experimental investigation of gratitude and subjective well-being in daily life. J Pers Soc Psychol. 2003 Feb;84(2):377-89. — View Citation

Schleider J, Weisz J. A single-session growth mindset intervention for adolescent anxiety and depression: 9-month outcomes of a randomized trial. J Child Psychol Psychiatry. 2018 Feb;59(2):160-170. doi: 10.1111/jcpp.12811. Epub 2017 Sep 18. — View Citation

Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in The Warwick-Edinburgh Mental Wellbeing Scale	Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.	Baseline, 4 week follow-up, 12 week follow-up
Primary	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.	Immediately post-intervention (i.e., 0 weeks)
Secondary	Patient Health Questionnaire-9	Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.	Baseline, 4 week follow-up, 12 week follow-up
Secondary	Generalized Anxiety Disorder Screener-7	Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.	Baseline, 4 week follow-up, 12 week follow-up
Secondary	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.	Baseline, 4 week follow-up, 12 week follow-up
Secondary	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.	Immediately post-intervention (i.e., 0 weeks)
Secondary	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.	Immediately post-intervention (i.e., 0 weeks)
Secondary	Perceived Stress Scale-4	Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.	Baseline, 4 week follow-up, 12 week follow-up