Testing a Digital Intervention for Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Rumination
• Intervention / Treatment: Behavioral: Happify Teens

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 Type: Interventional
• Enrollment (Actual): 353
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10012
      • Happify (an online platform -- study is entirely online)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control; Waitlist Control Condition
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress [Perceived Stress Scale (PSS)]	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). Scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.	Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]	A 5-item measure of rumination (brooding) assessing how often participants engage with each of the 5 behaviors on a scale from almost never (1) to almost always (4). Ratings are summed so that total scores can range from 5 to 20, with higher scores indicating more brooding in the past month.	Baseline, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): March 13, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: HLS-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No