Skip to content

Mindfulness Program for Adolescents With 22q11DS

Online Mindfulness Intervention for Adolescents With 22q11DS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05849441
Enrollment
110
Registered
2023-05-08
Start date
2023-12-18
Completion date
2024-08-17
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

22Q11 Deletion Syndrome

Brief summary

The goal of this study is to evaluate the effectiveness of the Aware Program, an online mindfulness education program, with adolescents with 22q11DS and their parents.

Detailed description

Parent-adolescent pairs (N=60) will be recruited to participate in a randomized controlled trial. Consent, permission, and/or assent will be sought prior to participation in the study. Participant pairs will be randomized into one of two study arms: intervention and wait-list control. All participants will complete a web-based pre-test questionnaire. Adolescents and parents in the intervention group will then receive access to the Aware Program for four weeks. Approximately 4-5 weeks after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire (the post-test for the intervention group will include Consumer Satisfaction questions about the program). Adolescents and parents in the wait-list control group will then have the option of reviewing the Aware Program and will receive access for four weeks. After approximately four weeks, they will have the opportunity to complete the Consumer Satisfaction Questionnaire about the program.

Interventions

BEHAVIORALAware 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.

Sponsors

Innovation Research & Training
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

To be included in the study, youth must: * Have received a diagnosis of 22Q11.DS (also known as VeloCardioFacial Syndrome or DiGeorge syndrome) * Be between the ages of 12 and 19 years old * Have an IQ of greater than or equal to 55 * Have regular internet and computer access * Speak and read English (all study and program materials are in English) To be included in the study, parents must: * Have a participating youth in the study * Read fluently in English (all study and program materials are in English)

Exclusion criteria

\- Only one parent per youth may participate

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Adolescents' Coping SkillsBaseline 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.
Change From Baseline in Adolescents' Emotion RegulationBaseline 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.
Change From Baseline in Adolescents' Emotional Self-efficacyBaseline 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.
Change From Baseline in Adolescents' General AnxietyBaseline and Week 4Adolescents 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.
Change From Baseline in Adolescents' Social AnxietyBaseline 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.
Change From Baseline in Adolescents' WellbeingBaseline and Week 4Adolescents 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.
Change From Baseline in Parent Report of Adolescents' Emotion RegulationBaseline 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.
Change From Baseline in Parent Report of Adolescents' Executive FunctioningBaseline 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.
Change From Baseline in Parent Report of Adolescents' AnxietyBaseline 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.
Change From Baseline in Parent Report of Adolescents' WellbeingBaseline 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.

Countries

United States

Participant flow

Pre-assignment details

55 parent-adolescent pairs (which totals 110 participants) were randomized to condition (intervention or wait-list control).

Participants by arm

ArmCount
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.
50
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).
54
Total104

Baseline characteristics

CharacteristicWait-List ControlTotalOnline Mindfulness Intervention
Adolescent psychological diagnosis
No
7 Participants12 Participants5 Participants
Adolescent psychological diagnosis
Yes
20 Participants40 Participants20 Participants
Age, Continuous
Adolescent
14.92 years
STANDARD_DEVIATION 1.75
14.73 years
STANDARD_DEVIATION 1.96
14.52 years
STANDARD_DEVIATION 2.18
Age, Continuous
Parent
51.30 years
STANDARD_DEVIATION 8
48.77 years
STANDARD_DEVIATION 8.37
46.04 years
STANDARD_DEVIATION 8.02
Ethnicity (NIH/OMB)
Adolescent
Hispanic or Latino
0 Participants5 Participants5 Participants
Ethnicity (NIH/OMB)
Adolescent
Not Hispanic or Latino
26 Participants45 Participants19 Participants
Ethnicity (NIH/OMB)
Adolescent
Unknown or Not Reported
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Parent
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Parent
Not Hispanic or Latino
26 Participants50 Participants24 Participants
Ethnicity (NIH/OMB)
Parent
Unknown or Not Reported
0 Participants0 Participants0 Participants
Parent education
College degree or higher
23 Participants38 Participants15 Participants
Parent education
No college degree or less
4 Participants14 Participants10 Participants
Race (NIH/OMB)
Adolescent
American Indian or Alaska Native
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Adolescent
Asian
3 Participants5 Participants2 Participants
Race (NIH/OMB)
Adolescent
Black or African American
1 Participants3 Participants2 Participants
Race (NIH/OMB)
Adolescent
More than one race
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Adolescent
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent
Unknown or Not Reported
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Adolescent
White
19 Participants38 Participants19 Participants
Race (NIH/OMB)
Parent
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
Asian
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Parent
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Parent
More than one race
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Parent
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
White
22 Participants43 Participants21 Participants
Region of Enrollment
United States
54 Participants104 Participants50 Participants
Sex: Female, Male
Adolescent
Female
10 Participants23 Participants13 Participants
Sex: Female, Male
Adolescent
Male
17 Participants29 Participants12 Participants
Sex: Female, Male
Parent
Female
26 Participants50 Participants24 Participants
Sex: Female, Male
Parent
Male
1 Participants2 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 500 / 54
serious
Total, serious adverse events
0 / 500 / 54

Outcome results

Primary

Change From Baseline in Adolescents' Coping Skills

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.

Time frame: Baseline and Week 4

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Adolescents' Coping SkillsSupport Seeking3.10 units on a scaleStandard Error 0.15
Online Mindfulness InterventionChange From Baseline in Adolescents' Coping SkillsProblem Solving3.18 units on a scaleStandard Error 0.12
Online Mindfulness InterventionChange From Baseline in Adolescents' Coping SkillsDistancing2.67 units on a scaleStandard Error 0.09
Online Mindfulness InterventionChange From Baseline in Adolescents' Coping SkillsInternalizing2.69 units on a scaleStandard Error 0.11
Online Mindfulness InterventionChange From Baseline in Adolescents' Coping SkillsExternalizing2.41 units on a scaleStandard Error 0.12
Online Mindfulness InterventionChange From Baseline in Adolescents' Coping SkillsMindfulness3.11 units on a scaleStandard Error 0.16
Wait-List ControlChange From Baseline in Adolescents' Coping SkillsExternalizing2.42 units on a scaleStandard Error 0.11
Wait-List ControlChange From Baseline in Adolescents' Coping SkillsSupport Seeking2.68 units on a scaleStandard Error 0.13
Wait-List ControlChange From Baseline in Adolescents' Coping SkillsInternalizing2.64 units on a scaleStandard Error 0.1
Wait-List ControlChange From Baseline in Adolescents' Coping SkillsProblem Solving2.79 units on a scaleStandard Error 0.11
Wait-List ControlChange From Baseline in Adolescents' Coping SkillsMindfulness2.73 units on a scaleStandard Error 0.15
Wait-List ControlChange From Baseline in Adolescents' Coping SkillsDistancing2.60 units on a scaleStandard Error 0.08
p-value: 0.04Regression, Linear
p-value: 0.02Regression, Linear
p-value: 0.55Regression, Linear
p-value: 0.79Regression, Linear
p-value: 0.93Regression, Linear
p-value: 0.09Regression, Linear
Primary

Change From Baseline in Adolescents' Emotional Self-efficacy

Adolescents 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.

Time frame: Baseline and Week 4

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Adolescents' Emotional Self-efficacyManage own emotions3.33 units on a scaleStandard Error 0.1
Online Mindfulness InterventionChange From Baseline in Adolescents' Emotional Self-efficacyIdentify and understand own emotions3.70 units on a scaleStandard Error 0.14
Online Mindfulness InterventionChange From Baseline in Adolescents' Emotional Self-efficacyDeal with emotions of others3.21 units on a scaleStandard Error 0.11
Online Mindfulness InterventionChange From Baseline in Adolescents' Emotional Self-efficacyPerceive emotion through faces and bodies3.40 units on a scaleStandard Error 0.16
Wait-List ControlChange From Baseline in Adolescents' Emotional Self-efficacyPerceive emotion through faces and bodies3.51 units on a scaleStandard Error 0.14
Wait-List ControlChange From Baseline in Adolescents' Emotional Self-efficacyManage own emotions3.24 units on a scaleStandard Error 0.09
Wait-List ControlChange From Baseline in Adolescents' Emotional Self-efficacyDeal with emotions of others3.38 units on a scaleStandard Error 0.1
Wait-List ControlChange From Baseline in Adolescents' Emotional Self-efficacyIdentify and understand own emotions3.96 units on a scaleStandard Error 0.12
p-value: 0.53Regression, Linear
p-value: 0.16Regression, Linear
p-value: 0.27Regression, Linear
p-value: 0.59Regression, Linear
Primary

Change From Baseline in Adolescents' Emotion Regulation

Adolescents 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.

Time frame: Baseline and Week 4

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Adolescents' Emotion RegulationReappraisal4.49 units on a scaleStandard Error 0.21
Online Mindfulness InterventionChange From Baseline in Adolescents' Emotion RegulationSuppression3.59 units on a scaleStandard Error 0.19
Wait-List ControlChange From Baseline in Adolescents' Emotion RegulationReappraisal4.21 units on a scaleStandard Error 0.18
Wait-List ControlChange From Baseline in Adolescents' Emotion RegulationSuppression3.28 units on a scaleStandard Error 0.17
p-value: 0.32Regression, Linear
p-value: 0.24Regression, Linear
Primary

Change From Baseline in Adolescents' General Anxiety

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.

Time frame: Baseline and Week 4

Population: Missing data from two adolescents

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Adolescents' General Anxiety5.90 units on a scaleStandard Error 1.07
Wait-List ControlChange From Baseline in Adolescents' General Anxiety8.08 units on a scaleStandard Error 0.92
p-value: 0.16Regression, Linear
Primary

Change From Baseline in Adolescents' Social Anxiety

Adolescents 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.

Time frame: Baseline and Week 4

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Adolescents' Social AnxietyFear of negative evaluation23.06 units on a scaleStandard Error 1.49
Online Mindfulness InterventionChange From Baseline in Adolescents' Social AnxietySocial avoidance and distress (new)19.68 units on a scaleStandard Error 1.06
Online Mindfulness InterventionChange From Baseline in Adolescents' Social AnxietySocial avoidance and distress (general)11.62 units on a scaleStandard Error 0.65
Wait-List ControlChange From Baseline in Adolescents' Social AnxietyFear of negative evaluation22.14 units on a scaleStandard Error 1.32
Wait-List ControlChange From Baseline in Adolescents' Social AnxietySocial avoidance and distress (new)20.43 units on a scaleStandard Error 0.94
Wait-List ControlChange From Baseline in Adolescents' Social AnxietySocial avoidance and distress (general)10.56 units on a scaleStandard Error 0.57
p-value: 0.65Regression, Linear
p-value: 0.6Regression, Linear
p-value: 0.23Regression, Linear
Primary

Change From Baseline in Adolescents' Wellbeing

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.

Time frame: Baseline and Week 4

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Adolescents' Wellbeing45.60 T scoreStandard Error 1.86
Wait-List ControlChange From Baseline in Adolescents' Wellbeing47.11 T scoreStandard Error 1.62
p-value: 0.55Regression, Linear
Primary

Change From Baseline in Parent Report of Adolescents' Anxiety

Parents 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.

Time frame: Baseline and Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Parent Report of Adolescents' Anxiety8.59 units on a scaleStandard Error 0.48
Wait-List ControlChange From Baseline in Parent Report of Adolescents' Anxiety8.10 units on a scaleStandard Error 0.42
p-value: 0.45Regression, Linear
Primary

Change From Baseline in Parent Report of Adolescents' Emotion Regulation

Parents 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.

Time frame: Baseline and Week 4

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Parent Report of Adolescents' Emotion RegulationNegativity2.05 units on a scaleStandard Error 0.05
Online Mindfulness InterventionChange From Baseline in Parent Report of Adolescents' Emotion RegulationEmotion Regulation2.82 units on a scaleStandard Error 0.06
Wait-List ControlChange From Baseline in Parent Report of Adolescents' Emotion RegulationNegativity2.17 units on a scaleStandard Error 0.05
Wait-List ControlChange From Baseline in Parent Report of Adolescents' Emotion RegulationEmotion Regulation2.84 units on a scaleStandard Error 0.05
p-value: 0.11Regression, Linear
p-value: 0.79Regression, Linear
Primary

Change From Baseline in Parent Report of Adolescents' Executive Functioning

Parents 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.

Time frame: Baseline and Week 4

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Parent Report of Adolescents' Executive FunctioningInhibit2.96 units on a scaleStandard Error 0.09
Online Mindfulness InterventionChange From Baseline in Parent Report of Adolescents' Executive FunctioningWorking Memory3.54 units on a scaleStandard Error 0.1
Online Mindfulness InterventionChange From Baseline in Parent Report of Adolescents' Executive FunctioningRegulate3.93 units on a scaleStandard Error 0.13
Online Mindfulness InterventionChange From Baseline in Parent Report of Adolescents' Executive FunctioningPlanning3.71 units on a scaleStandard Error 0.13
Wait-List ControlChange From Baseline in Parent Report of Adolescents' Executive FunctioningRegulate4.09 units on a scaleStandard Error 0.11
Wait-List ControlChange From Baseline in Parent Report of Adolescents' Executive FunctioningWorking Memory3.73 units on a scaleStandard Error 0.08
Wait-List ControlChange From Baseline in Parent Report of Adolescents' Executive FunctioningInhibit3.04 units on a scaleStandard Error 0.08
Wait-List ControlChange From Baseline in Parent Report of Adolescents' Executive FunctioningPlanning3.93 units on a scaleStandard Error 0.12
p-value: 0.14Regression, Linear
p-value: 0.2Regression, Linear
p-value: 0.48Regression, Linear
p-value: 0.37Regression, Linear
Primary

Change From Baseline in Parent Report of Adolescents' Wellbeing

Parents 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.

Time frame: Baseline and Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Online Mindfulness InterventionChange From Baseline in Parent Report of Adolescents' Wellbeing37.88 T scoreStandard Error 0.82
Wait-List ControlChange From Baseline in Parent Report of Adolescents' Wellbeing37.71 T scoreStandard Error 0.73
p-value: 0.88Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026