Mindfulness Program for Adolescents With 22q11DS

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-18

Study Completion Date

2024-08-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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22Q11 Deletion Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Online mindfulness 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 Type EXPERIMENTAL

Aware Program

Intervention Type BEHAVIORAL

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.

Wait-List Control

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)