Mindfulness Program for Adolescents With 22q11DS

22Q11 Deletion Syndrome Clinical Trial

Official title:

Online Mindfulness Intervention for Adolescents With 22q11DS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849441
• Other study ID #: MindfulnessinTeens-SBIR-23-001
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Innovation Research & Training
• Contact: Alison Parker, PhD
• Phone: 919-493-7700
• Email: aparker[@]irtinc.us
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

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

Related Conditions & MeSH terms

• 22Q11 Deletion Syndrome
• DiGeorge Syndrome

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	innovation Research & Training	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Innovation Research & Training

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and Week 4
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.	Baseline and Week 4
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.	Baseline and Week 4
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 averaged and the minimum scale score is 0 and the maximum scale score is 3. Higher scores indicate greater general anxiety.	Baseline and Week 4
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 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.	Baseline and Week 4
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. 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.	Baseline and Week 4
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.	Baseline and Week 4
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.	Baseline and Week 4
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; 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.	Baseline and Week 4
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. 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.	Baseline and Week 4