NCT03982563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
958

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

June 5, 2019

Last Update Submit

June 25, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Patient Health Questionnaire-9

    Baseline, 4 week follow-up, 12 week follow-up

  • Generalized Anxiety Disorder Screener-7

    Baseline, 4 week follow-up, 12 week follow-up

  • The EPOCH Measure of Adolescent Well-being

    Baseline, 4 week follow-up, 12 week follow-up

  • Acceptability of Intervention Measure

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

  • Feasibility of Intervention Measure

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

  • +1 more secondary outcomes

Study Arms (4)

Growth Mindset

EXPERIMENTAL
Behavioral: Growth Mindset

Gratitude

EXPERIMENTAL
Behavioral: Gratitude

Behavioral Activation

EXPERIMENTAL
Behavioral: Behavioral Activation

Study Skills

SHAM COMPARATOR
Behavioral: Study Skills

Interventions

Growth MindsetBEHAVIORAL

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

Growth Mindset
GratitudeBEHAVIORAL

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

Gratitude

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

Behavioral Activation
Study SkillsBEHAVIORAL

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

Study Skills

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dr. Kalmadi Junior High School

Pune, Maharashtra, India

Location

The Orchid School

Pune, Maharashtra, India

Location

JM Rathi English School

Roha, Maharashtra, India

Location

Modern College Pune

Pune, India

Location

Related Publications (4)

  • 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.

    PMID: 28921523BACKGROUND
  • 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.

    PMID: 16045394BACKGROUND
  • 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.

    PMID: 12585811BACKGROUND
  • 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.

    PMID: 17450056BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Rob DeRubeis, PhD

    University of Pennsylvania

    STUDY DIRECTOR
  • Sachin Shinde, PhD

    Sangath

    STUDY DIRECTOR
  • Sadhana Natu, PhD

    Modern College Pune

    STUDY DIRECTOR
  • Akash Wasil

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 11, 2019

Study Start

July 31, 2019

Primary Completion

March 15, 2020

Study Completion

June 4, 2020

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations