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Mindfulness Program

Online mindfulness intervention for DiGeorge Syndrome

N/A
Recruiting
Led By Alison Parker, PhD
Research Sponsored by Innovation Research & Training
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between the ages of 12 and 19 years old
Have an IQ of greater than or equal to 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 4
Awards & highlights

Study Summary

This trial aims to see if an online mindfulness program can help teens with 22q11DS and their parents.

Who is the study for?
This trial is for adolescents aged 12-19 with a condition called 22q11DS, who have an IQ of 60 or above and can read and speak English. They must have regular internet access to use the online program. Both the adolescent and their parents need to participate.Check my eligibility
What is being tested?
The study tests the Aware Program, which is an online mindfulness education course designed specifically for young people with DiGeorge syndrome (22q11DS) and their parents.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on education and mindfulness training, no direct medical side effects are expected. However, participants may experience increased awareness of emotions which could be uncomfortable initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 19 years old.
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My IQ is 60 or above.
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I have been diagnosed with 22Q11.2 deletion syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in adolescents' coping skills
Change from baseline in adolescents' emotion regulation
Change from baseline in adolescents' emotional self-efficacy
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Online mindfulness interventionExperimental Treatment1 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.
Group II: Wait-List ControlActive Control1 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).

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Who is running the clinical trial?

Innovation Research & TrainingLead Sponsor
11 Previous Clinical Trials
7,027 Total Patients Enrolled
Alison Parker, PhDPrincipal InvestigatorInnovation Research & Training
4 Previous Clinical Trials
884 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for this clinical trial?

"As stated on clinicaltrials.gov, this trial is actively seeking participants to partake in the study. It was initially posted on 1st of December 2023 and had its last update occur 13th of that same month."

Answered by AI

Is enrollment open to individuals of all ages, or are there age restrictions for this research study?

"As stated in the qualifications for this trial, individuals between 12 and 19 years old may apply."

Answered by AI

What is the highest possible number of participants involved in this experiment?

"Correct. Clinicaltrials.gov data affirms that this investigation, originally posted on December 1st 2023, is presently seeking applicants. Sixty volunteers must be recruited from a single medical institution."

Answered by AI

How can I be considered for participation in this research?

"This medical research seeks 60 adolescents aged 12-19 with Digeorge Syndrome. To be eligible, they must have the 22Q11.DS diagnosis, display an IQ of at least 60 points or higher, possess regular access to a computer and internet connection, demonstrate proficient English reading ability and comprehension in their native language as all materials are written exclusively in English, plus there should also be another participating youth involved in this study."

Answered by AI
~0 spots leftby May 2024