Clinical trial · Interventional
Pediatric Reporting of Adult-Onset Genomic Results
Reporting Adult-Onset Genomic Results to Pediatric Biobank Participants and Parents
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Hypercholesterolemia | — | UNRESOLVED | — |
| Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adolescent controls - negative for familial variant | Genetic | — | UNRESOLVED |
| Adolescents who received adult-onset result | Genetic | — | UNRESOLVED |
| Adolescents who received a pediatric-onset result | Genetic | — | UNRESOLVED |
| Child(ren) receive an adult-onset result | Genetic | — | UNRESOLVED |
| Child(ren) received a pediatric-onset result | Genetic | — | UNRESOLVED |
| Control - Negative Result | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Group 1 - Parents of child(ren) who receive an adult-onset result
- description
- Compare change in psychosocial outcomes of parents of child(ren) with a pathogenic variant in a gene associated with adult onset of disease.
- interventionNames
- Genetic: Child(ren) receive an adult-onset result
- type
- EXPERIMENTAL
- label
- Group 2 - Parents of child(ren) who receive a pediatric-onset result
- description
- Compare change in psychosocial outcomes among parents of child(ren) with a pathogenic variant in a gene associated with pediatric onset of disease or with risk reduction interventions that begin in childhood.
- interventionNames
- Genetic: Child(ren) received a pediatric-onset result
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (26)
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- BACKGROUNDBoterhoven de Haan KL, Hafekost J, Lawrence D, Sawyer MG, Zubrick SR. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113. Epub 2014 Nov 11. PMID 25385473
- BACKGROUNDMoos R, Moos B. Family Environment Scale Manual: Development, Applications, Research. 3rd ed. Palo Alto, CA: Consulting Psychologist Press; 1994
- BACKGROUNDRosenberg M. Society and the adolescent self-image. Princeton, NJ: Princeton University Press; 1965
- BACKGROUNDBrehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005. PMID 12926578
- BACKGROUNDDeMarco TA, Peshkin BN, Mars BD, Tercyak KP. Patient satisfaction with cancer genetic counseling: a psychometric analysis of the Genetic Counseling Satisfaction Scale. J Genet Couns. 2004 Aug;13(4):293-304. doi: 10.1023/b:jogc.0000035523.96133.bc. PMID 19736695
- BACKGROUNDBond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.