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Mindfulness Program for Adolescents With 22q11DS

Primary Purpose

22Q11 Deletion Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aware Program
Sponsored by
Innovation Research & Training
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for 22Q11 Deletion Syndrome

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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 60 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Online mindfulness intervention

    Wait-List Control

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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 averaged and the minimum scale score is 0 and the maximum scale score is 3. Higher scores indicate greater general anxiety.
    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 averaged across the three factors and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater social anxiety.
    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. 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 will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater wellbeing.
    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.
    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.
    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; 1 = Never; 4 = Always) that assess parent ratings of their adolescents' anxiety. Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 4. Higher scores indicate greater anxiety.
    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. 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 will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater wellbeing.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2023
    Last Updated
    September 27, 2023
    Sponsor
    Innovation Research & Training
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05849441
    Brief Title
    Mindfulness Program for Adolescents With 22q11DS
    Official Title
    Online Mindfulness Intervention for Adolescents With 22q11DS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Innovation Research & Training

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    22Q11 Deletion Syndrome

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Online mindfulness intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Wait-List Control
    Arm Type
    No Intervention
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Aware Program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from baseline in adolescents' coping skills
    Description
    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
    Title
    Change from baseline in adolescents' emotion regulation
    Description
    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
    Title
    Change from baseline in adolescents' emotional self-efficacy
    Description
    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
    Title
    Change from baseline in adolescents' general anxiety
    Description
    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 averaged and the minimum scale score is 0 and the maximum scale score is 3. Higher scores indicate greater general anxiety.
    Time Frame
    Baseline and Week 4
    Title
    Change from baseline in adolescents' social anxiety
    Description
    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 averaged across the three factors and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater social anxiety.
    Time Frame
    Baseline and Week 4
    Title
    Change from baseline in adolescents' wellbeing
    Description
    Adolescents will be asked to respond to a total of 7 items that assess their overall health and wellbeing. 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 will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater wellbeing.
    Time Frame
    Baseline and Week 4
    Title
    Change from baseline in parent report of adolescents' emotion regulation
    Description
    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
    Title
    Change from baseline in parent report of adolescents' executive functioning
    Description
    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.
    Time Frame
    Baseline and Week 4
    Title
    Change from baseline in parent report of adolescents' anxiety
    Description
    Parents will be asked to respond to 8 questions (e.g., My child worries about things; 1 = Never; 4 = Always) that assess parent ratings of their adolescents' anxiety. Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 4. Higher scores indicate greater anxiety.
    Time Frame
    Baseline and Week 4
    Title
    Change from baseline in parent report of adolescents' wellbeing
    Description
    Parents will be asked to respond to a total of 7 items that assess parent ratings of their adolescents' overall health and wellbeing. 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 will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater wellbeing.
    Time Frame
    Baseline and Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 60 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alison Parker, PhD
    Phone
    919-493-7700
    Email
    aparker@irtinc.us
    First Name & Middle Initial & Last Name or Official Title & Degree
    Janis Kupersmidt, PhD
    Phone
    919-493-7700
    Email
    jkupersmidt@irtinc.us
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alison Parker, PhD
    Organizational Affiliation
    Innovation Research & Training
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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