Testing a Digital Intervention for Adolescents

NCT04567888 | Completed Results

• 1 other identifier: HLS-20
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

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.

Conditions

Rumination; Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]

  Baseline, 4 weeks, 8 weeks, 12 weeks

Study Arms (2)

Happify Teens

ACTIVE COMPARATOR

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

Behavioral: Happify Teens

Waitlist Control

NO INTERVENTION

Waitlist Control Condition

Interventions

Happify Teens BEHAVIORAL

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

Happify Teens

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Happify Inc.: lead

Study Sites (1)

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

New York, New York, 10012, United States

Location

Related Publications (2)

• 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.

  PMID: 38551617 DERIVED

• 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.

  PMID: 33871377 DERIVED

MeSH Terms

Conditions

Rumination Syndrome; Stress, Psychological

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Eliane M. Boucher, PhD (Sr Director of Research Strategy)
• Organization: Twill

eliane@twill.health

(800) 264-6428

Study Officials

• Eliane Boucher, PhD

  Happify Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: June 3, 2021
• Primary Completion: March 13, 2022
• Study Completion: April 11, 2022
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-03

Locations

US (1)