NCT07316647

Brief Summary

This study aims to test whether a brief digital intervention using conversational AI can improve mental health outcomes among school-aged youth (grades 6-8) in India, where most young people with mental health issues do not receive treatment. The intervention teaches "growth mindset", the belief that skills and abilities can improve with effort, via a 45-minute interactive conversation with an AI chatbot (spread across two class periods). A randomized controlled trial with approximately 430 students at a private, English-medium school in Bangalore will evaluate whether interacting with the chatbot can reduce symptoms of anxiety and depression while enhancing growth mindset beliefs. Half the students will receive the full intervention at baseline, while the other half (control group) will complete a usual school assignment; after 7 weeks, the control group will receive a shortened (15-minute) version of the growth mindset intervention. Participants will complete 10-minute surveys at baseline, 3 weeks, and 7 weeks, after which all students will receive a printed booklet with all the information from the chatbot. This study represents one of the first randomized controlled trials evaluating conversational AI as a brief digital intervention for youth mental health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
383

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

December 5, 2025

Last Update Submit

January 25, 2026

Conditions

Keywords

growth mindsetbrief digital mental health intervention

Outcome Measures

Primary Outcomes (2)

  • Change in Behavior and Feelings Survey - Internalizing Subscale (full sample)

    Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing Subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms (BFS; Weisz et al., 2020).

    Baseline, 3 weeks, 7 weeks

  • Student Perceived Program Acceptability and Helpfulness

    Assessed via the Program Feedback Scale (Schleider et al., 2019). This scale consists of 7 items rated on a 1 to 5 scale, with higher scores indicating greater acceptability and helpfulness.

    Immediately post-intervention

Secondary Outcomes (3)

  • Change in Behavior and Feelings Survey - Internalizing Subscale (elevated subsample)

    Baseline, 3 weeks, 7 weeks

  • Change in Growth Mindset Beliefs (full sample and elevated subsample)

    Baseline, 3 weeks, 7 weeks

  • Growth mindset reflections (intervention group)

    3 weeks, 7 weeks

Study Arms (2)

Growth mindset training

EXPERIMENTAL

Receives growth mindset training via 45-minute interaction with conversational AI

Behavioral: Growth mindset training using conversational AI

Usual classroom activities

NO INTERVENTION

Performs usual classroom activities during the intervention period; receives delayed and shortened intervention at the conclusion of the study

Interventions

Participants will interact with an AI chatbot for approximately 45 minutes. The tutorial has a structured script and pauses at section boundaries to allow for brief interactions. It also contains culturally-grounded comics and illustrations with role-playing scenarios to engage with students.

Growth mindset training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Youth in grades 6-8 at our partner school
  • Youth assents to participate and a parent/guardian provides passive consent (does not opt-out of participation)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Partner school

Bangalore, Karnataka, India

Location

Related Publications (1)

  • Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.

    PMID: 30657721BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • John R Weisz, Ph.D.

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Half the students will be randomly assigned to receive the full intervention at baseline, while the other half (control group) will complete a usual school assignment; after 7 weeks, the control group will receive a shortened (15-minute) version of the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Henry Ford II Research Professor of the Social Sciences, Department of Psychology

Study Record Dates

First Submitted

December 5, 2025

First Posted

January 5, 2026

Study Start

November 3, 2025

Primary Completion

January 9, 2026

Study Completion

January 9, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

To respect concerns shared by our school partner regarding privacy of student data, individual participant data will not be shared with outside researchers.

Locations