Early Phase 1
Completed N=162
Pediatric Reporting of Adult-Onset Genomic Results
Source: ClinicalTrials.gov NCT03832985 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: The Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale — 10.32; 8.26; 8.96 units on scale
Summary
The Investigators will conduct a longitudinal, mixed-methods cohort study to assess primary and secondary psychosocial outcomes among MyCode adolescent participants and their parents, and health behaviors of children who received an adult- or pediatric-onset genomic result. Data will be gathered via quantitative surveys using validated measures of distress, family functioning, quality of life, body image, perceived cancer/heart disease risk, genetic counseling satisfaction, genomics knowledge, and adjustment to genetic information; qualitative interviews with adolescents and parents; and electronic health records review of children's initiation of risk reduction behaviors. The investigators will also conduct empirical and theoretical legal research to examine the loss of chance doctrine and its applicability to genomic research.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale |
8.9; 6.12; 5.5 | — |
| PRIMARY The Hospital Anxiety and Depression Scale (HADS) - Depression Subscale |
4.4; 3.31; 2.39 | — |
| PRIMARY The General Functioning 12-item Subscale (GF12) of The McMaster Family Assessment Device (FAD) |
1.5; 1.4; 1.6 | — |
| PRIMARY Health-Related Quality of Life (HRQOL) |
0; 0; 1 | — |
| PRIMARY Initiation of Risk Reduction Behavior |
0; 13 | — |
| PRIMARY Revised Children's Anxiety and Depression Scale - Anxiety Subscale |
56.85; 44.24; 35.86 | — |
| PRIMARY Revised Children's Anxiety and Depression Scale - Depression Subscale |
70.55; 44.36; 36.75 | — |
| PRIMARY General Functioning 12-item Subscale (GF12) of the McMaster Family Assessment Device (FAD) |
1.71; 1.70; 1.82 | — |
| SECONDARY Decision Regret Scale |
7.7; 8.1; 5.9 | — |
Eligibility Criteria
Inclusion Criteria
- Any pediatric MyCode participant (ages 0-17) OR
- Parent of a pediatric MyCode participant who has given assent to participate in this study.
Exclusion Criteria
- Individuals who have already had genetic counseling for any of the actionable target conditions as part of their routine clinical care.
- Individuals who have already had genetic counseling for any of the actionable target conditions through their participation in another research study.
Data sourced from ClinicalTrials.gov (NCT03832985). 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. Informational only — not medical advice.