CompletedNot Applicable

Mindfulness Program for Adolescents With 22q11DS

United States110 participantsStarted 2023-12-18

Plain-language 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.

Who can participate

Age range

12 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Adolescents' Coping Skills

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' Emotion Regulation

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' Emotional Self-efficacy

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' General Anxiety

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' Social Anxiety

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' Wellbeing

Timeframe: Baseline and Week 4

Change From Baseline in Parent Report of Adolescents' Emotion Regulation

Timeframe: Baseline and Week 4

Trial details

NCT IDNCT05849441

SponsorInnovation Research & Training

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-17

Results submitted2024-12-06

View on ClinicalTrials.gov More 22Q11 Deletion Syndrome trials

Who can participate

Age range

12 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Adolescents' Coping Skills

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' Emotion Regulation

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' Emotional Self-efficacy

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' General Anxiety

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' Social Anxiety

Timeframe: Baseline and Week 4

Change From Baseline in Adolescents' Wellbeing

Timeframe: Baseline and Week 4

Change From Baseline in Parent Report of Adolescents' Emotion Regulation

Timeframe: Baseline and Week 4