22Q11 Deletion Syndrome
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Adolescents' Coping Skills | Baseline and Week 4 | 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. |
| Change From Baseline in Adolescents' Emotion Regulation | Baseline and Week 4 | 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. |
| Change From Baseline in Adolescents' Emotional Self-efficacy | Baseline and Week 4 | 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. |
| Change From Baseline in Adolescents' General Anxiety | Baseline and Week 4 | 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. |
| Change From Baseline in Adolescents' Social Anxiety | Baseline and Week 4 | 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. |
| Change From Baseline in Adolescents' Wellbeing | Baseline and Week 4 | 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. |
| Change From Baseline in Parent Report of Adolescents' Emotion Regulation | Baseline and Week 4 | 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. |
| Change From Baseline in Parent Report of Adolescents' Executive Functioning | Baseline and Week 4 | 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. |
| Change From Baseline in Parent Report of Adolescents' Anxiety | Baseline and Week 4 | 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. |
| Change From Baseline in Parent Report of Adolescents' Wellbeing | Baseline and Week 4 | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 104 |
Baseline characteristics
| Characteristic | Wait-List Control | Total | Online Mindfulness Intervention |
|---|---|---|---|
| Adolescent psychological diagnosis No | 7 Participants | 12 Participants | 5 Participants |
| Adolescent psychological diagnosis Yes | 20 Participants | 40 Participants | 20 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 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Adolescent Not Hispanic or Latino | 26 Participants | 45 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Adolescent Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Parent Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Parent Not Hispanic or Latino | 26 Participants | 50 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Parent Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parent education College degree or higher | 23 Participants | 38 Participants | 15 Participants |
| Parent education No college degree or less | 4 Participants | 14 Participants | 10 Participants |
| Race (NIH/OMB) Adolescent American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Adolescent Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Adolescent Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Adolescent More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Adolescent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent White | 19 Participants | 38 Participants | 19 Participants |
| Race (NIH/OMB) Parent American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Parent Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Parent More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Parent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent White | 22 Participants | 43 Participants | 21 Participants |
| Region of Enrollment United States | 54 Participants | 104 Participants | 50 Participants |
| Sex: Female, Male Adolescent Female | 10 Participants | 23 Participants | 13 Participants |
| Sex: Female, Male Adolescent Male | 17 Participants | 29 Participants | 12 Participants |
| Sex: Female, Male Parent Female | 26 Participants | 50 Participants | 24 Participants |
| Sex: Female, Male Parent Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 50 | 0 / 54 |
| serious Total, serious adverse events | 0 / 50 | 0 / 54 |
Outcome results
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Coping Skills | Support Seeking | 3.10 units on a scale | Standard Error 0.15 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Coping Skills | Problem Solving | 3.18 units on a scale | Standard Error 0.12 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Coping Skills | Distancing | 2.67 units on a scale | Standard Error 0.09 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Coping Skills | Internalizing | 2.69 units on a scale | Standard Error 0.11 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Coping Skills | Externalizing | 2.41 units on a scale | Standard Error 0.12 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Coping Skills | Mindfulness | 3.11 units on a scale | Standard Error 0.16 |
| Wait-List Control | Change From Baseline in Adolescents' Coping Skills | Externalizing | 2.42 units on a scale | Standard Error 0.11 |
| Wait-List Control | Change From Baseline in Adolescents' Coping Skills | Support Seeking | 2.68 units on a scale | Standard Error 0.13 |
| Wait-List Control | Change From Baseline in Adolescents' Coping Skills | Internalizing | 2.64 units on a scale | Standard Error 0.1 |
| Wait-List Control | Change From Baseline in Adolescents' Coping Skills | Problem Solving | 2.79 units on a scale | Standard Error 0.11 |
| Wait-List Control | Change From Baseline in Adolescents' Coping Skills | Mindfulness | 2.73 units on a scale | Standard Error 0.15 |
| Wait-List Control | Change From Baseline in Adolescents' Coping Skills | Distancing | 2.60 units on a scale | Standard Error 0.08 |
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Emotional Self-efficacy | Manage own emotions | 3.33 units on a scale | Standard Error 0.1 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Emotional Self-efficacy | Identify and understand own emotions | 3.70 units on a scale | Standard Error 0.14 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Emotional Self-efficacy | Deal with emotions of others | 3.21 units on a scale | Standard Error 0.11 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Emotional Self-efficacy | Perceive emotion through faces and bodies | 3.40 units on a scale | Standard Error 0.16 |
| Wait-List Control | Change From Baseline in Adolescents' Emotional Self-efficacy | Perceive emotion through faces and bodies | 3.51 units on a scale | Standard Error 0.14 |
| Wait-List Control | Change From Baseline in Adolescents' Emotional Self-efficacy | Manage own emotions | 3.24 units on a scale | Standard Error 0.09 |
| Wait-List Control | Change From Baseline in Adolescents' Emotional Self-efficacy | Deal with emotions of others | 3.38 units on a scale | Standard Error 0.1 |
| Wait-List Control | Change From Baseline in Adolescents' Emotional Self-efficacy | Identify and understand own emotions | 3.96 units on a scale | Standard Error 0.12 |
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Emotion Regulation | Reappraisal | 4.49 units on a scale | Standard Error 0.21 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Emotion Regulation | Suppression | 3.59 units on a scale | Standard Error 0.19 |
| Wait-List Control | Change From Baseline in Adolescents' Emotion Regulation | Reappraisal | 4.21 units on a scale | Standard Error 0.18 |
| Wait-List Control | Change From Baseline in Adolescents' Emotion Regulation | Suppression | 3.28 units on a scale | Standard Error 0.17 |
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Adolescents' General Anxiety | 5.90 units on a scale | Standard Error 1.07 |
| Wait-List Control | Change From Baseline in Adolescents' General Anxiety | 8.08 units on a scale | Standard Error 0.92 |
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Social Anxiety | Fear of negative evaluation | 23.06 units on a scale | Standard Error 1.49 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Social Anxiety | Social avoidance and distress (new) | 19.68 units on a scale | Standard Error 1.06 |
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Social Anxiety | Social avoidance and distress (general) | 11.62 units on a scale | Standard Error 0.65 |
| Wait-List Control | Change From Baseline in Adolescents' Social Anxiety | Fear of negative evaluation | 22.14 units on a scale | Standard Error 1.32 |
| Wait-List Control | Change From Baseline in Adolescents' Social Anxiety | Social avoidance and distress (new) | 20.43 units on a scale | Standard Error 0.94 |
| Wait-List Control | Change From Baseline in Adolescents' Social Anxiety | Social avoidance and distress (general) | 10.56 units on a scale | Standard Error 0.57 |
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Adolescents' Wellbeing | 45.60 T score | Standard Error 1.86 |
| Wait-List Control | Change From Baseline in Adolescents' Wellbeing | 47.11 T score | Standard Error 1.62 |
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Parent Report of Adolescents' Anxiety | 8.59 units on a scale | Standard Error 0.48 |
| Wait-List Control | Change From Baseline in Parent Report of Adolescents' Anxiety | 8.10 units on a scale | Standard Error 0.42 |
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Parent Report of Adolescents' Emotion Regulation | Negativity | 2.05 units on a scale | Standard Error 0.05 |
| Online Mindfulness Intervention | Change From Baseline in Parent Report of Adolescents' Emotion Regulation | Emotion Regulation | 2.82 units on a scale | Standard Error 0.06 |
| Wait-List Control | Change From Baseline in Parent Report of Adolescents' Emotion Regulation | Negativity | 2.17 units on a scale | Standard Error 0.05 |
| Wait-List Control | Change From Baseline in Parent Report of Adolescents' Emotion Regulation | Emotion Regulation | 2.84 units on a scale | Standard Error 0.05 |
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Parent Report of Adolescents' Executive Functioning | Inhibit | 2.96 units on a scale | Standard Error 0.09 |
| Online Mindfulness Intervention | Change From Baseline in Parent Report of Adolescents' Executive Functioning | Working Memory | 3.54 units on a scale | Standard Error 0.1 |
| Online Mindfulness Intervention | Change From Baseline in Parent Report of Adolescents' Executive Functioning | Regulate | 3.93 units on a scale | Standard Error 0.13 |
| Online Mindfulness Intervention | Change From Baseline in Parent Report of Adolescents' Executive Functioning | Planning | 3.71 units on a scale | Standard Error 0.13 |
| Wait-List Control | Change From Baseline in Parent Report of Adolescents' Executive Functioning | Regulate | 4.09 units on a scale | Standard Error 0.11 |
| Wait-List Control | Change From Baseline in Parent Report of Adolescents' Executive Functioning | Working Memory | 3.73 units on a scale | Standard Error 0.08 |
| Wait-List Control | Change From Baseline in Parent Report of Adolescents' Executive Functioning | Inhibit | 3.04 units on a scale | Standard Error 0.08 |
| Wait-List Control | Change From Baseline in Parent Report of Adolescents' Executive Functioning | Planning | 3.93 units on a scale | Standard Error 0.12 |
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Online Mindfulness Intervention | Change From Baseline in Parent Report of Adolescents' Wellbeing | 37.88 T score | Standard Error 0.82 |
| Wait-List Control | Change From Baseline in Parent Report of Adolescents' Wellbeing | 37.71 T score | Standard Error 0.73 |