Trial Outcomes & Findings for Mindfulness Program for Adolescents With 22q11DS (NCT NCT05849441)
NCT ID: NCT05849441
Last Updated: 2025-04-29
Results Overview
Adolescents will be asked to respond to 34 questions (e.g., Try to think of different ways to solve it; 1 = Never; 5 = Always) that assess their coping in response to stressors across 5 domains: Seeking Social Support, Problem Solving, Distancing, Externalizing, and Internalizing. Three items related to mindfulness skills will be included as a mindfulness subscale. Responses will be averaged across each domain and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater use of the coping strategy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2025-04-29
Participant Flow
55 parent-adolescent pairs (which totals 110 participants) were randomized to condition (intervention or wait-list control).
Participant milestones
| Measure |
Online Mindfulness Intervention
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
56
|
|
Overall Study
Completed Pretest
|
50
|
54
|
|
Overall Study
COMPLETED
|
42
|
54
|
|
Overall Study
NOT COMPLETED
|
12
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The overall sample includes parents and adolescents. The analysis population for adolescent age includes just adolescents and the analysis population for parent age includes just parents.
Baseline characteristics by cohort
| Measure |
Online Mindfulness Intervention
n=50 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=54 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Adolescent
|
14.52 years
STANDARD_DEVIATION 2.18 • n=25 Participants • The overall sample includes parents and adolescents. The analysis population for adolescent age includes just adolescents and the analysis population for parent age includes just parents.
|
14.92 years
STANDARD_DEVIATION 1.75 • n=27 Participants • The overall sample includes parents and adolescents. The analysis population for adolescent age includes just adolescents and the analysis population for parent age includes just parents.
|
14.73 years
STANDARD_DEVIATION 1.96 • n=52 Participants • The overall sample includes parents and adolescents. The analysis population for adolescent age includes just adolescents and the analysis population for parent age includes just parents.
|
|
Age, Continuous
Parent
|
46.04 years
STANDARD_DEVIATION 8.02 • n=25 Participants • The overall sample includes parents and adolescents. The analysis population for adolescent age includes just adolescents and the analysis population for parent age includes just parents.
|
51.30 years
STANDARD_DEVIATION 8.00 • n=27 Participants • The overall sample includes parents and adolescents. The analysis population for adolescent age includes just adolescents and the analysis population for parent age includes just parents.
|
48.77 years
STANDARD_DEVIATION 8.37 • n=52 Participants • The overall sample includes parents and adolescents. The analysis population for adolescent age includes just adolescents and the analysis population for parent age includes just parents.
|
|
Sex: Female, Male
Adolescent · Female
|
13 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
10 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
23 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Sex: Female, Male
Adolescent · Male
|
12 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
17 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
29 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Sex: Female, Male
Parent · Female
|
24 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
26 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
50 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Sex: Female, Male
Parent · Male
|
1 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
1 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
2 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Ethnicity (NIH/OMB)
Adolescent · Hispanic or Latino
|
5 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
0 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
5 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Adolescent · Not Hispanic or Latino
|
19 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
26 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
45 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Adolescent · Unknown or Not Reported
|
1 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
1 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
2 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Parent · Hispanic or Latino
|
1 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
1 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
2 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Parent · Not Hispanic or Latino
|
24 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
26 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
50 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Parent · Unknown or Not Reported
|
0 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
0 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
0 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · American Indian or Alaska Native
|
1 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · Asian
|
2 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
3 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
5 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · Black or African American
|
2 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
3 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · White
|
19 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
19 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
38 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · More than one race
|
1 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · Unknown or Not Reported
|
0 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · American Indian or Alaska Native
|
0 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · Asian
|
2 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
4 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · Black or African American
|
0 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · White
|
21 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
22 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
43 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · More than one race
|
2 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
4 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · Unknown or Not Reported
|
0 Participants
n=25 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=27 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=52 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Region of Enrollment
United States
|
50 Participants
n=50 Participants
|
54 Participants
n=54 Participants
|
104 Participants
n=104 Participants
|
|
Adolescent psychological diagnosis
Yes
|
20 Participants
n=25 Participants • The overall sample includes parents and adolescents. This item only asked about the adolescents' psychological diagnosis.
|
20 Participants
n=27 Participants • The overall sample includes parents and adolescents. This item only asked about the adolescents' psychological diagnosis.
|
40 Participants
n=52 Participants • The overall sample includes parents and adolescents. This item only asked about the adolescents' psychological diagnosis.
|
|
Adolescent psychological diagnosis
No
|
5 Participants
n=25 Participants • The overall sample includes parents and adolescents. This item only asked about the adolescents' psychological diagnosis.
|
7 Participants
n=27 Participants • The overall sample includes parents and adolescents. This item only asked about the adolescents' psychological diagnosis.
|
12 Participants
n=52 Participants • The overall sample includes parents and adolescents. This item only asked about the adolescents' psychological diagnosis.
|
|
Parent education
No college degree or less
|
10 Participants
n=25 Participants • The overall sample includes parents and adolescents. This item only asked about the parents' education.
|
4 Participants
n=27 Participants • The overall sample includes parents and adolescents. This item only asked about the parents' education.
|
14 Participants
n=52 Participants • The overall sample includes parents and adolescents. This item only asked about the parents' education.
|
|
Parent education
College degree or higher
|
15 Participants
n=25 Participants • The overall sample includes parents and adolescents. This item only asked about the parents' education.
|
23 Participants
n=27 Participants • The overall sample includes parents and adolescents. This item only asked about the parents' education.
|
38 Participants
n=52 Participants • The overall sample includes parents and adolescents. This item only asked about the parents' education.
|
PRIMARY outcome
Timeframe: Baseline and Week 4Adolescents will be asked to respond to 34 questions (e.g., Try to think of different ways to solve it; 1 = Never; 5 = Always) that assess their coping in response to stressors across 5 domains: Seeking Social Support, Problem Solving, Distancing, Externalizing, and Internalizing. Three items related to mindfulness skills will be included as a mindfulness subscale. Responses will be averaged across each domain and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater use of the coping strategy.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=21 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=27 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Change From Baseline in Adolescents' Coping Skills
Support Seeking
|
3.10 units on a scale
Standard Error .15
|
2.68 units on a scale
Standard Error .13
|
|
Change From Baseline in Adolescents' Coping Skills
Problem Solving
|
3.18 units on a scale
Standard Error .12
|
2.79 units on a scale
Standard Error .11
|
|
Change From Baseline in Adolescents' Coping Skills
Distancing
|
2.67 units on a scale
Standard Error .09
|
2.60 units on a scale
Standard Error .08
|
|
Change From Baseline in Adolescents' Coping Skills
Internalizing
|
2.69 units on a scale
Standard Error .11
|
2.64 units on a scale
Standard Error .10
|
|
Change From Baseline in Adolescents' Coping Skills
Externalizing
|
2.41 units on a scale
Standard Error .12
|
2.42 units on a scale
Standard Error .11
|
|
Change From Baseline in Adolescents' Coping Skills
Mindfulness
|
3.11 units on a scale
Standard Error .16
|
2.73 units on a scale
Standard Error .15
|
PRIMARY outcome
Timeframe: Baseline and Week 4Adolescents will be asked to respond to 10 questions (e.g., I keep my emotions to myself; 1 = Strongly disagree; 7 = Strongly agree) that assess their use of two emotion regulation strategies: Cognitive Reappraisal and Suppression. Responses will be averaged across each strategy and the minimum scale is 1 and the maximum scale score is 7. Higher scores indicate greater use of the emotion regulation strategy.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=21 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=27 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Change From Baseline in Adolescents' Emotion Regulation
Reappraisal
|
4.49 units on a scale
Standard Error .21
|
4.21 units on a scale
Standard Error .18
|
|
Change From Baseline in Adolescents' Emotion Regulation
Suppression
|
3.59 units on a scale
Standard Error .19
|
3.28 units on a scale
Standard Error .17
|
PRIMARY outcome
Timeframe: Baseline and Week 4Adolescents will be asked to respond to 27 questions (e.g., I can tell when my feelings change; 1 = Not confident at all; 5 = Very confident) that assess their beliefs about their ability to understand and manage emotions. The measure has four factors: Using and managing your own emotions; Identifying and understanding your own emotions; Dealing with emotions in others; Perceiving emotion through facial expressions and body language. Responses will be averaged across the four factors and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater emotional self-efficacy.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=21 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=27 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Change From Baseline in Adolescents' Emotional Self-efficacy
Manage own emotions
|
3.33 units on a scale
Standard Error .10
|
3.24 units on a scale
Standard Error .09
|
|
Change From Baseline in Adolescents' Emotional Self-efficacy
Identify and understand own emotions
|
3.70 units on a scale
Standard Error .14
|
3.96 units on a scale
Standard Error .12
|
|
Change From Baseline in Adolescents' Emotional Self-efficacy
Deal with emotions of others
|
3.21 units on a scale
Standard Error .11
|
3.38 units on a scale
Standard Error .10
|
|
Change From Baseline in Adolescents' Emotional Self-efficacy
Perceive emotion through faces and bodies
|
3.40 units on a scale
Standard Error .16
|
3.51 units on a scale
Standard Error .14
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Missing data from two adolescents
Adolescents will be asked to respond to 7 items that assess general anxiety (e.g., Over the last two weeks, how often have you been bothered by the following problems… feeling nervous, anxious, or on edge; 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). Responses will be summed across the 7 items and the minimum scale score is 0 and the maximum scale score is 21. Higher scores indicate greater general anxiety.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=20 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=26 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Change From Baseline in Adolescents' General Anxiety
|
5.90 units on a scale
Standard Error 1.07
|
8.08 units on a scale
Standard Error .92
|
PRIMARY outcome
Timeframe: Baseline and Week 4Adolescents will be asked to respond to 18 items (e.g., It's hard for me to ask others to do things with me; 1 = Not at all; 5 = All the time) that assess social anxiety. The measure has three factors: Fear of Negative Evaluation, Social Avoidance and Distress-New; Social Avoidance and Distress. Responses will be summed across each of the three factors. The minimum scale score is 1 and the maximum scale score is 40. Higher scores indicate greater social anxiety.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=21 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=27 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Change From Baseline in Adolescents' Social Anxiety
Fear of negative evaluation
|
23.06 units on a scale
Standard Error 1.49
|
22.14 units on a scale
Standard Error 1.32
|
|
Change From Baseline in Adolescents' Social Anxiety
Social avoidance and distress (new)
|
19.68 units on a scale
Standard Error 1.06
|
20.43 units on a scale
Standard Error .94
|
|
Change From Baseline in Adolescents' Social Anxiety
Social avoidance and distress (general)
|
11.62 units on a scale
Standard Error .65
|
10.56 units on a scale
Standard Error .57
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: All 7 items in this measure had to be answered in order to produce a valid global health T score. If a participant did not answer all 7 questions, no score was included in the dataset. Thus, 4 participants were excluded from the analysis of this measure.
Adolescents will be asked to respond to a total of 7 items that assess their overall health and wellbeing using the PROMIS Pediatric Scale - Global Health 7 measure. Adolescents will respond to 4 items (e.g., In general, would you say your quality of life is…; 5 = Excellent, 1 = Poor); 1 item (e.g., How often do you feel really sad; 5 = Never; 1 = Always); and 2 items (e.g., How often do you have fun with friends?; 5 = Always; 1 = Never). Responses were summed across the 7 items to create a single global health score. The scoring table in the PROMIS Global Health Scoring manual was used to convert a summed global health score into a T score value for each participant. The T score has a mean of 50 with a standard deviation of 10. Higher T scores on this measure represent greater adolescent overall health and wellbeing.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=19 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
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Wait-List Control
n=25 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
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|---|---|---|
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Change From Baseline in Adolescents' Wellbeing
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45.60 T score
Standard Error 1.86
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47.11 T score
Standard Error 1.62
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PRIMARY outcome
Timeframe: Baseline and Week 4Parents will be asked to respond to 24 questions (e.g., Responds positively to neutral or friendly overtures by peers; 1= Never; 4 = Always) that assess parent ratings of their adolescents' emotion regulatory abilities. There are two subscales for this measure: Emotion Regulation and Negativity. Responses will be averaged across the two subscales and the minimum scale score is 1 and the maximum scale score is 4. Higher scores indicate greater use of the emotion regulation strategy.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=21 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=27 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
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|---|---|---|
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Change From Baseline in Parent Report of Adolescents' Emotion Regulation
Negativity
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2.05 units on a scale
Standard Error .05
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2.17 units on a scale
Standard Error .05
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Change From Baseline in Parent Report of Adolescents' Emotion Regulation
Emotion Regulation
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2.82 units on a scale
Standard Error .06
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2.84 units on a scale
Standard Error .05
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PRIMARY outcome
Timeframe: Baseline and Week 4Parents will be asked to respond to 24 questions (e.g., Has difficulty thinking ahead or learning from experience; 1 = Definitely not true; 5 = Definitely true) that assess parent ratings of their adolescents' executive functioning. There are four subscales: Working Memory, Planning, Inhibition, and Regulation. Responses will be averaged across the four subscales and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater executive functioning deficit.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=21 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=27 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Change From Baseline in Parent Report of Adolescents' Executive Functioning
Working Memory
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3.54 units on a scale
Standard Error .10
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3.73 units on a scale
Standard Error .08
|
|
Change From Baseline in Parent Report of Adolescents' Executive Functioning
Planning
|
3.71 units on a scale
Standard Error .13
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3.93 units on a scale
Standard Error .12
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Change From Baseline in Parent Report of Adolescents' Executive Functioning
Inhibit
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2.96 units on a scale
Standard Error .09
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3.04 units on a scale
Standard Error .08
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Change From Baseline in Parent Report of Adolescents' Executive Functioning
Regulate
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3.93 units on a scale
Standard Error .13
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4.09 units on a scale
Standard Error .11
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PRIMARY outcome
Timeframe: Baseline and Week 4Parents will be asked to respond to 8 questions (e.g., My child worries about things; 0 = Never; 3 = Always) that assess parent ratings of their adolescents' anxiety. Responses will be summed across the 8 items and the minimum scale score is 0 and the maximum scale score is 24. Higher scores indicate greater anxiety.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=21 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=27 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Change From Baseline in Parent Report of Adolescents' Anxiety
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8.59 units on a scale
Standard Error .48
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8.10 units on a scale
Standard Error .42
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PRIMARY outcome
Timeframe: Baseline and Week 4Parents will be asked to respond to a total of 7 items that assess parent ratings of their adolescents' overall health and wellbeing using the PROMIS Parent Proxy Scale - Global Health 7. Parents will respond to 4 items (e.g., In general, would you say your child's quality of life is…; 5 = Excellent, 1 = Poor); 1 item (e.g., How often does your child feel really sad; 5 = Never; 1 = Always); and 2 items (e.g., How often does your child have fun with friends?; 5 = Always; 1 = Never). Responses were summed across the 7 items to create a single global health score. The scoring table in the PROMIS Global Health Scoring manual was used to convert a summed global health score into a T score value for each participant. The T score has a mean of 50 with a standard deviation of 10. Higher T scores on this measure represent greater adolescent overall health wellbeing as rated by their parent.
Outcome measures
| Measure |
Online Mindfulness Intervention
n=21 Participants
Participants will have access to the intervention between pre-test and post-test assessments. The intervention, Aware Program, is an online mindfulness education program for adolescents with 22q11DS designed to enhance their coping skills and ability to manage stress and anxiety in healthy ways.
Aware Program: The program includes interactive, multimedia lessons for adolescent participants to learn, practice, and apply different mindfulness skills. Parent-adolescent pairs will have the option to subscribe to a mobile messaging service that includes progress reminders, encouragement, and practice content. Parent participants also have access to online resources to support and monitor their teen's use of the program.
|
Wait-List Control
n=27 Participants
Participants will not have access to the online mindfulness intervention between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the online mindfulness intervention (Aware Program).
|
|---|---|---|
|
Change From Baseline in Parent Report of Adolescents' Wellbeing
|
37.88 T score
Standard Error .82
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37.71 T score
Standard Error .73
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Adverse Events
Online Mindfulness Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-List 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place