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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online mindfulness intervention | Experimental | 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. |
|
| Wait-List Control | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aware Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 4 |
| 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. | Baseline and Week 4 |
| 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. | Baseline and Week 4 |
| 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. |
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Inclusion Criteria:
To be included in the study, youth must:
To be included in the study, parents must:
Exclusion Criteria:
- Only one parent per youth may participate
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| Name | Affiliation | Role |
|---|---|---|
| Alison Parker, PhD | Innovation Research & Training | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| innovation Research & Training | Durham | North Carolina | 27713 | United States |
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55 parent-adolescent pairs (which totals 110 participants) were randomized to condition (intervention or wait-list control).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 4 |
|
6 weeks
The participants in the study completed web-based questionnaires and utilized an online mindfulness education program (if in the intervention group). The risks associated with this study were minimal and the participants were not at risk for mortality as a function of participating in this study. Because this study investigated an online behavioral intervention, All-Cause Mortality was not monitored or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Parker | innovation Research & Training | 919-493-7700 | aparker@irtinc.us |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2023 | Nov 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058165 | 22q11 Deletion Syndrome |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D006330 | Heart Defects, Congenital |
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|
| Baseline and Week 4 |
| 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. | Baseline and Week 4 |
| 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. | Baseline and Week 4 |
| 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. | Baseline and Week 4 |
| 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. | Baseline and Week 4 |
| 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. | Baseline and Week 4 |
| 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. | Baseline and Week 4 |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Adolescent psychological diagnosis | The overall sample includes parents and adolescents. This item only asked about the adolescents' psychological diagnosis. | Count of Participants | Participants |
|
| Parent education | The overall sample includes parents and adolescents. This item only asked about the parents' education. | Count of Participants | Participants |
|
| OG001 | 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). |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 4 |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 4 |
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| 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. | Missing data from two adolescents | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 4 |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 4 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | T score | Baseline and Week 4 |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 4 |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 4 |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 4 |
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| 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. | Posted | Least Squares Mean | Standard Error | T score | Baseline and Week 4 |
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| 0 |
| 0 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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). | 0 | 0 | 0 | 54 | 0 | 54 |
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| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D044148 | Lymphatic Abnormalities |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D007011 | Hypoparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
This is for subscale: Suppression |
| Superiority |
| Deal with emotions of others |
|
| Perceive emotion through faces and bodies |
|
This is for subscale: Identify and Understand Own Emotions |
| Superiority |
| Regression, Linear | 0.27 | This is for subscale: Deal with emotions of others | Superiority |
| Regression, Linear | 0.59 | This is for subscale: Perceive emotions through faces and bodies | Superiority |
| Social avoidance and distress (general) |
|
This is for subscale: Social avoidance and distress (new) |
| Superiority |
| Regression, Linear | 0.23 | This is for subscale: social avoidance and distress (general) | Superiority |
This is for subscale: Emotion regulation |
| Superiority |
| Inhibit |
|
| Regulate |
|
This is for subscale: Planning |
| Superiority |
| Regression, Linear | 0.48 | This is for subscale: Inhibit | Superiority |
| Regression, Linear | 0.37 | This is for subscale: Regulation | Superiority |