Well-beingNCT03982563
Computerized Single-Session Interventions for Indian Adolescents
A study testing Growth Mindset, Gratitude and Behavioral Activation in people with Well-being and Depression, run by University of Pennsylvania at 4 sites in India.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-being, Depression, Anxiety
- What is being tested?
- Growth Mindset, Gratitude and Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 958 participants
- Where
- 4 sitesIndia
- Study dates
- 31 Jul 2019to 4 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Attending a participating secondary school
- Age 12 to 18
- Literate in English
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
India4 sites
Dr. Kalmadi Junior High School
Pune, Maharashtra
The Orchid School
Pune, Maharashtra
Modern College Pune
Pune
JM Rathi English School
Roha, Maharashtra
About this study
Official title: Evaluating the Acceptability and Efficacy of 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.
- Conditions
- Well-being, Depression, Anxiety
- Being tested
- Growth Mindset, Gratitude, Behavioral Activation, Study Skills
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth MindsetBehavioural
Reading and writing activities designed to instill the belief that people can change.
GratitudeBehavioural
Reading and writing activities designed to practice noticing and appreciating good things in life.
Behavioral ActivationBehavioural
Reading and writing activities designed to identify and schedule positive activities.
Study SkillsBehavioural
Reading and writing activities designed to learn evidence-based study strategies.
| Study group | Role | What they receive |
|---|---|---|
| Growth Mindset | Experimental | Not described Receives: Behavioral: Growth Mindset |
| Gratitude | Experimental | Not described Receives: Behavioral: Gratitude |
| Behavioral Activation | Experimental | Not described Receives: Behavioral: Behavioral Activation |
| Study Skills | Sham comparator | Not described Receives: Behavioral: Study Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Warwick-Edinburgh Mental Wellbeing Scale
Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.
Measured: 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.
Measured: Immediately post-intervention (i.e., 0 weeks)
Secondary outcomes (6)
Patient Health Questionnaire-9
Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.
Measured: Baseline, 4 week follow-up, 12 week follow-up
Generalized Anxiety Disorder Screener-7
Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.
Measured: Baseline, 4 week follow-up, 12 week follow-up
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.
Measured: Baseline, 4 week follow-up, 12 week follow-up
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.
Measured: Immediately post-intervention (i.e., 0 weeks)
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.
Measured: Immediately post-intervention (i.e., 0 weeks)
Perceived Stress Scale-4
Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.
Measured: Baseline, 4 week follow-up, 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start31 Jul 2019
- Primary completion15 Mar 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Well-beingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 958 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Sangath
- Responsible party
- Principal investigator, Akash Wasil, University of Pennsylvania
- Investigators
- Rob DeRubeis, PhD, Study director, University of PennsylvaniaSachin Shinde, PhD, Study director, SangathSadhana Natu, PhD, Study director, Modern College PuneAkash Wasil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982563
- Sponsor's protocol ID
- 24922
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2019
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28921523Seligman 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.
PubMed 16045394Emmons 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.
PubMed 12585811Chorpita 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.
PubMed 17450056
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents
- ClinicalTrials.gov ID
- NCT03982563
- Acronym / sponsor ID
- 24922
- Conditions
- Well-being, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 958 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Sangath
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Growth Mindset | Experimental | Behavioral: Growth Mindset |
| Gratitude | Experimental | Behavioral: Gratitude |
| Behavioral Activation | Experimental | Behavioral: Behavioral Activation |
| Study Skills | Sham comparator | Behavioral: Study Skills |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Attending a participating secondary school
- Age 12 to 18
- Literate in English
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth MindsetReading and writing activities designed to instill the belief that people can change. | Behavioural | Growth Mindset |
| GratitudeReading and writing activities designed to practice noticing and appreciating good things in life. | Behavioural | Gratitude |
| Behavioral ActivationReading and writing activities designed to identify and schedule positive activities. | Behavioural | Behavioral Activation |
| Study SkillsReading and writing activities designed to learn evidence-based study strategies. | Behavioural | Study Skills |
Primary outcome
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.
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.
6 secondary outcomes
Patient Health Questionnaire-9
Time frame: Baseline, 4 week follow-up, 12 week follow-up
Generalized Anxiety Disorder Screener-7
Time frame: Baseline, 4 week follow-up, 12 week follow-up
The EPOCH Measure of Adolescent Well-being
Time frame: Baseline, 4 week follow-up, 12 week follow-up
Acceptability of Intervention Measure
Time frame: Immediately post-intervention (i.e., 0 weeks)
Feasibility of Intervention Measure
Time frame: Immediately post-intervention (i.e., 0 weeks)
Perceived Stress Scale-4
Time frame: Baseline, 4 week follow-up, 12 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Background: PubMed 28921523Schleider 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.
- Background: PubMed 16045394Seligman 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.
- Background: PubMed 12585811Emmons 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.
- Background: PubMed 17450056Chorpita 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob DeRubeis, PhD study director
University of Pennsylvania
Sachin Shinde, PhD study director
Sangath
Sadhana Natu, PhD study director
Modern College Pune
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Mindset, Gratitude and Behavioral Activation in people with Well-being and Depression, run by University of Pennsylvania at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Warwick-Edinburgh Mental Wellbeing Scale (time frame: Baseline, 4 week follow-up, 12 week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982563, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.