Mindfulness Program for Adolescents With 22q11DS

Innovation Research & Training

Status: Completed

Conditions: 22Q11 Deletion Syndrome

Treatments: Behavioral: Aware Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05849441

MindfulnessinTeens-SBIR-23-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: Accepts 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 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Online mindfulness intervention

Experimental group

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.

Treatment:

Behavioral: Aware Program

Wait-List Control

No Intervention group

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).