Trial Outcomes & Findings for Testing a Digital Intervention for Adolescents (NCT NCT04567888)
NCT ID: NCT04567888
Last Updated: 2024-08-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
353 participants
Primary outcome timeframe
Baseline, 4 weeks, 8 weeks, 12 weeks
Results posted on
2024-08-15
Participant Flow
Participant milestones
| Measure |
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.
|
Waitlist Control
Waitlist Control Condition
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
175
|
|
Overall Study
COMPLETED
|
132
|
171
|
|
Overall Study
NOT COMPLETED
|
46
|
4
|
Reasons for withdrawal
| Measure |
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.
|
Waitlist Control
Waitlist Control Condition
|
|---|---|---|
|
Overall Study
Did Not Create Happify for Teens Account
|
22
|
0
|
|
Overall Study
Did Not Complete Any Happify for Teens Activities
|
22
|
0
|
|
Overall Study
Reported Unusual Birth Year
|
2
|
3
|
|
Overall Study
Duplicate Responses
|
0
|
1
|
Baseline Characteristics
Testing a Digital Intervention for Adolescents
Baseline characteristics by cohort
| Measure |
Happify Teens
n=178 Participants
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.
|
Waitlist Control
n=175 Participants
Waitlist Control Condition
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
13 years
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Customized
14 years
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Age, Customized
15 years
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Customized
16 years
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Customized
17 years
|
47 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Customized
Missing or Unusual Birth Year
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
122 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
42 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary/Other
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
178 participants
n=5 Participants
|
175 participants
n=7 Participants
|
353 participants
n=5 Participants
|
|
Perceived Stress Scale
|
26.06 score on a scale
STANDARD_DEVIATION 4.41 • n=5 Participants
|
25.29 score on a scale
STANDARD_DEVIATION 5.04 • n=7 Participants
|
25.68 score on a scale
STANDARD_DEVIATION 4.74 • n=5 Participants
|
|
Ruminative Responses Scale - Brooding Subscale
|
14.18 score on a scale
STANDARD_DEVIATION 2.32 • n=5 Participants
|
14.29 score on a scale
STANDARD_DEVIATION 2.55 • n=7 Participants
|
14.23 score on a scale
STANDARD_DEVIATION 2.44 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks10-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.
Outcome measures
| Measure |
Happify Teens
n=132 Participants
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.
|
Waitlist Control
n=171 Participants
Waitlist Control Condition
|
|---|---|---|
|
Change in Perceived Stress [Perceived Stress Scale (PSS)]
12 weeks
|
20.96 score on a scale
Standard Deviation 6.57
|
24.44 score on a scale
Standard Deviation 6.27
|
|
Change in Perceived Stress [Perceived Stress Scale (PSS)]
Baseline
|
26.33 score on a scale
Standard Deviation 4.43
|
25.26 score on a scale
Standard Deviation 4.97
|
|
Change in Perceived Stress [Perceived Stress Scale (PSS)]
4 weeks
|
22.01 score on a scale
Standard Deviation 6.10
|
24.67 score on a scale
Standard Deviation 5.36
|
|
Change in Perceived Stress [Perceived Stress Scale (PSS)]
8 weeks
|
21.95 score on a scale
Standard Deviation 6.20
|
24.61 score on a scale
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksA 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.
Outcome measures
| Measure |
Happify Teens
n=132 Participants
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.
|
Waitlist Control
n=171 Participants
Waitlist Control Condition
|
|---|---|---|
|
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
Baseline
|
14.29 score on a scale
Standard Deviation 2.36
|
14.29 score on a scale
Standard Deviation 2.56
|
|
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
4 weeks
|
12.53 score on a scale
Standard Deviation 3.24
|
13.89 score on a scale
Standard Deviation 3.01
|
|
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
8 weeks
|
11.94 score on a scale
Standard Deviation 2.89
|
13.20 score on a scale
Standard Deviation 2.85
|
|
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
12 weeks
|
11.68 score on a scale
Standard Deviation 3.18
|
13.46 score on a scale
Standard Deviation 3.03
|
Adverse Events
Happify Teens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eliane M. Boucher, PhD (Sr Director of Research Strategy)
Twill
Phone: (800) 264-6428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place