Testing a Digital Intervention for Adolescents
Primary Purpose
Rumination, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Happify Teens
Sponsored by
About this trial
This is an interventional other trial for Rumination
Eligibility Criteria
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
Sites / Locations
- Happify (an online platform -- study is entirely online)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Happify Teens
Waitlist Control
Arm Description
Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser
Waitlist Control Condition
Outcomes
Primary Outcome Measures
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), with higher scores indicating higher levels of perceived stress.
Secondary Outcome Measures
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04567888
Brief Title
Testing a Digital Intervention for Adolescents
Official Title
Testing a Digital Intervention for Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
March 13, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Happify Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rumination, Stress, Psychological
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Allocation
Randomized
Enrollment
353 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Happify Teens
Arm Type
Active Comparator
Arm Description
Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Waitlist Control Condition
Intervention Type
Behavioral
Intervention Name(s)
Happify Teens
Intervention Description
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
Primary Outcome Measure Information:
Title
Change in Perceived Stress [Perceived Stress Scale (PSS)]
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliane Boucher, PhD
Organizational Affiliation
Happify Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Happify (an online platform -- study is entirely online)
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33871377
Citation
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.
Results Reference
derived
Learn more about this trial
Testing a Digital Intervention for Adolescents
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