Clinical trial NCT05849441: Mindfulness Program for Adolescents With 22q11DS
Official title: Online Mindfulness Intervention for Adolescents With 22q11DS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 22Q11 Deletion Syndrome
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 110
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Adolescents' Coping Skills
timeFrame: Baseline and Week 4
measure: Change From Baseline in Adolescents' Emotion Regulation
timeFrame: Baseline and Week 4
measure: Change From Baseline in Adolescents' Emotional Self-efficacy
timeFrame: Baseline and Week 4
measure: Change From Baseline in Adolescents' General Anxiety
timeFrame: Baseline and Week 4
measure: Change From Baseline in Adolescents' Social Anxiety
timeFrame: Baseline and Week 4
measure: Change From Baseline in Adolescents' Wellbeing
timeFrame: Baseline and Week 4
measure: Change From Baseline in Parent Report of Adolescents' Emotion Regulation
timeFrame: Baseline and Week 4
measure: Change From Baseline in Parent Report of Adolescents' Executive Functioning
timeFrame: Baseline and Week 4
measure: Change From Baseline in Parent Report of Adolescents' Anxiety
timeFrame: Baseline and Week 4
measure: Change From Baseline in Parent Report of Adolescents' Wellbeing
timeFrame: Baseline and Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: innovation Research & Training
state: North Carolina
Study officials:
affiliation: Innovation Research & Training
name: Alison Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References: