Testing a Digital Intervention for Adolescents

Sponsor
Happify Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04567888
Collaborator
(none)
307
1
2
10.3
29.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Happify Teens
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
307 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Testing a Digital Intervention for Adolescents
Actual Study Start Date :
Jun 3, 2021
Actual Primary Completion Date :
Mar 13, 2022
Actual Study Completion Date :
Apr 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Happify Teens

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

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

No Intervention: Waitlist Control

Waitlist Control Condition

Outcome Measures

Primary Outcome Measures

  1. Change in Perceived Stress [Perceived Stress Scale (PSS)] [Baseline, midpoint at 4 weeks, immediate post intervention at 8 weeks, and 1 month post intervention]

    10-item measure of perceived stress scoring how often the participant felt stressed by each statement in the following month from never (0) to very often (4), with higher scores indicating higher levels of perceived stress.

Secondary Outcome Measures

  1. Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] [Baseline, midpoint at 4 weeks, immediate post intervention at 8 weeks, and 1 month post intervention]

    A 5-item measure of rumination (brooding) scoring how often participants engage with each of the 5 behaviors on a scale from almost never (1) to almost always (4), with higher scores indicating more brooding in the past month.

  2. Change in Optimism [Life Orientation Test-Revised (LOT-R)] [Baseline, midpoint at 4 weeks, immediate post intervention at 8 weeks, and 1 month post intervention]

    10-item measure of optimism that measures the extent participants agree with each statement from strongly disagree (0) to strongly agree (4), with higher scores indicating greater levels of optimism.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Happify (an online platform -- study is entirely online) New York New York United States 10012

Sponsors and Collaborators

  • Happify Inc.

Investigators

  • Principal Investigator: Eliane Boucher, PhD, Happify Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Happify Inc.
ClinicalTrials.gov Identifier:
NCT04567888
Other Study ID Numbers:
  • HLS-20
First Posted:
Sep 29, 2020
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022