Testing a Digital Intervention for Adolescents

NCT ID: NCT04567888

Last Updated: 2024-08-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-03

Study Completion Date

2022-04-11

Brief Summary

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Teen participants (ages 13-17) will be randomly assigned to either an experimental (the Happify Teens digital platform), or a waitlist control group. The study includes an 8-week intervention period and a 1-month follow up period.

Detailed Description

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Teen participants (ages 13-17) will be randomly assigned to either the experimental group in which participants receive access to Happify Teens, a digital platform rooted in several therapeutic traditions that aims to improve wellbeing, or a waitlist control group. Both group conditions last 8 weeks. Participants assigned to the Happify Teens platform will have full access to the intervention, with featured tracks that focus on dealing with stress, worries and building skills for greater happiness. Participants assigned to the waitlist (control) condition will not have access to the Happify Teens platform for the full study period (12 weeks total). Participants in the waitlist control will receive access to Happify Teens after the full study period is complete (12 weeks). Perceived stress, rumination, and optimism will be assessed via self-report at baseline, end of the 8-week intervention, and at 1 month post intervention.

Conditions

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Rumination Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Happify Teens

Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser

Group Type ACTIVE_COMPARATOR

Happify Teens

Intervention Type BEHAVIORAL

An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

Waitlist Control

Waitlist Control Condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Happify Teens

An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 13-17 years of age
* US resident
* Perceived Stress Scale Score ≥ 10
* Ruminative Responses Scale Score ≥ 14
* Ability and willingness to complete study activities
* Willingness and access to using a digital intervention via mobile application or web browser

Exclusion Criteria

* Current or past user of any Happify platform
* Non-US Resident
* Perceived Stress Scale Score \< 10
* Ruminative Responses Scale Score \< 14
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Happify Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eliane Boucher, PhD

Role: PRINCIPAL_INVESTIGATOR

Happify Inc.

Locations

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Happify (an online platform -- study is entirely online)

New York, New York, United States

Site Status

Countries

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United States

References

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Boucher EM, Ward H, Miles CJ, Henry RD, Stoeckl SE. Effects of a Digital Mental Health Intervention on Perceived Stress and Rumination in Adolescents Aged 13 to 17 Years: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 29;26:e54282. doi: 10.2196/54282.

Reference Type DERIVED
PMID: 38551617 (View on PubMed)

Boucher EM, Ward HE, Stafford JL, Parks AC. Effects of a Digital Mental Health Program on Perceived Stress in Adolescents Aged 13-17 Years: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 19;10(4):e25545. doi: 10.2196/25545.

Reference Type DERIVED
PMID: 33871377 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HLS-20

Identifier Type: -

Identifier Source: org_study_id

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