Clinical trial NCT03982563: Computerized Single-Session Interventions for Indian Adolescents
Official title: Evaluating the Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Depression
Anxiety
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Sangath
First posted: 2019-06-11
Enrollment: 958
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Change in The Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
measure: Intervention Appropriateness Measure
timeFrame: Immediately post-intervention (i.e., 0 weeks)
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
measure: Generalized Anxiety Disorder Screener-7
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
measure: The EPOCH Measure of Adolescent Well-being
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
measure: Acceptability of Intervention Measure
timeFrame: Immediately post-intervention (i.e., 0 weeks)
measure: Feasibility of Intervention Measure
timeFrame: Immediately post-intervention (i.e., 0 weeks)
measure: Perceived Stress Scale-4
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
Other outcomes:
Locations:
city: Pune
country: India
facility: Dr. Kalmadi Junior High School
state: Maharashtra
city: Pune
country: India
facility: The Orchid School
state: Maharashtra
city: Roha
country: India
facility: JM Rathi English School
state: Maharashtra
city: Pune
country: India
facility: Modern College Pune
Study officials:
affiliation: University of Pennsylvania
name: Rob DeRubeis, PhD
role: STUDY_DIRECTOR
affiliation: Sangath
name: Sachin Shinde, PhD
role: STUDY_DIRECTOR
affiliation: Modern College Pune
name: Sadhana Natu, PhD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Akash Wasil
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1037/0003-066X.60.5.410.
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. doi: 10.1037//0022-3514.84.2.377.
citation: 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. doi: 10.1097/chi.0b013e318033ff71. No abstract available.