Testing a Digital Intervention for Adolescents

Stress, Psychological Clinical Trial

Official title:

Testing a Digital Intervention for Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567888
• Other study ID #: HLS-20
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: April 11, 2022

Study information

• Verified date: April 2023
• Source: Happify Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: April 11, 2022
• Est. primary completion date: March 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Rumination
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	Happify (an online platform -- study is entirely online)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Happify Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks