Mindfulness Program for Adolescents With 22q11DS

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Online Mindfulness Intervention for Adolescents With 22q11DS

ClinicalTrials.gov ID

NCT05849441

Acronym / sponsor ID

MindfulnessinTeens-SBIR-23-001

Conditions

22Q11 Deletion Syndrome

Study type

Interventional

Recruitment status

Completed

Enrolment

110 participants (actual)

Lead sponsor

Innovation Research & TrainingUniversity, hospital or other

Study start

18 Dec 2023 (actual)

Primary completion

17 Aug 2024 (actual)

Study completion

17 Aug 2024 (actual)

First posted

8 May 2023 (actual)

Results

Posted 29 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Health services research

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (participant)

Number of arms

2

Who may qualify

Ages

12 to 19 years

Sex

All

Healthy volunteers

Accepted

Age groups

Child, Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change From Baseline in Adolescents' Coping Skills

   Time frame: 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.

2. Change From Baseline in Adolescents' Emotion Regulation

   Time frame: 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.

3. Change From Baseline in Adolescents' Emotional Self-efficacy

   Time frame: 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.

4. Change From Baseline in Adolescents' General Anxiety

   Time frame: 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.

5. Change From Baseline in Adolescents' Social Anxiety

   Time frame: 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.

6. Change From Baseline in Adolescents' Wellbeing

   Time frame: 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.

7. Change From Baseline in Parent Report of Adolescents' Emotion Regulation

   Time frame: 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.

8. Change From Baseline in Parent Report of Adolescents' Executive Functioning

   Time frame: 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.

9. Change From Baseline in Parent Report of Adolescents' Anxiety

   Time frame: 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.

10. Change From Baseline in Parent Report of Adolescents' Wellbeing

    Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.