N/A N=110 Randomized Single-blind Health Services Research

Mindfulness Program for Adolescents With 22q11DS

22Q11 Deletion Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT05849441 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Change From Baseline in Adolescents' Coping Skills — 3.10; 2.68; 3.18; 2.79 units on a scale — p=0.04

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Aware Program (Behavioral)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: Innovation Research & Training
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Adolescents' Coping Skills	3.10; 2.68; 3.18; 2.79; 2.67; 2.60	0.04 sig
PRIMARY Change From Baseline in Adolescents' Emotion Regulation	4.49; 4.21; 3.59; 3.28	0.32
PRIMARY Change From Baseline in Adolescents' Emotional Self-efficacy	3.33; 3.24; 3.70; 3.96; 3.21; 3.38	0.53
PRIMARY Change From Baseline in Adolescents' General Anxiety	5.90; 8.08	0.16
PRIMARY Change From Baseline in Adolescents' Social Anxiety	23.06; 22.14; 19.68; 20.43; 11.62; 10.56	0.65
PRIMARY Change From Baseline in Adolescents' Wellbeing	45.60; 47.11	0.55
PRIMARY Change From Baseline in Parent Report of Adolescents' Emotion Regulation	2.05; 2.17; 2.82; 2.84	0.11
PRIMARY Change From Baseline in Parent Report of Adolescents' Executive Functioning	3.54; 3.73; 3.71; 3.93; 2.96; 3.04	0.14
PRIMARY Change From Baseline in Parent Report of Adolescents' Anxiety	8.59; 8.10	0.45
PRIMARY Change From Baseline in Parent Report of Adolescents' Wellbeing	37.88; 37.71	0.88

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05849441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.