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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Happify Teens | Active Comparator | Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser |
|
| Waitlist Control | No Intervention | Waitlist Control Condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Happify Teens | Behavioral | An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eliane Boucher, PhD | Happify Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Happify (an online platform -- study is entirely online) | New York | New York | 10012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38551617 | Derived | 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. | |
| 33871377 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Happify Teens | Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser Happify Teens: An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. |
| FG001 | Waitlist Control | Waitlist Control Condition |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Happify Teens | Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser Happify Teens: An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). Scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks |
|
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Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Happify Teens | Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser Happify Teens: An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eliane M. Boucher, PhD (Sr Director of Research Strategy) | Twill | (800) 264-6428 | eliane@twill.health |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2021 | Apr 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2022 | Mar 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000079562 | Rumination Syndrome |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
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| Reported Unusual Birth Year |
|
| Duplicate Responses |
|
| Waitlist Control |
Waitlist Control Condition |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Perceived Stress Scale | 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. | Mean | Standard Deviation | score on a scale |
|
| Ruminative Responses Scale - 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). Ratings are summed, so that total scores can range from 5 to 20, with higher scores indicating more brooding in the past month. | Mean | Standard Deviation | score on a scale |
|
Waitlist Control Condition
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Waitlist Control | Waitlist Control Condition | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| 8 weeks |
|
| 12 weeks |
|