A Program to Increase Sickle Cell Trait Knowledge Among Parent of Young Children Identified in Newborn Screening (SCTaware)

Susan Creary

Status: Completed

Conditions: Sickle Cell Trait

Treatments: Other: Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03984500

1R03HL146877-01 (U.S. NIH Grant/Contract)

STUDY00000122

Details and patient eligibility

About

This is a study for parents of young children with Sickle Cell Trait (SCT) identified by newborn screening who are referred and present for in person SCT education at the Institution.

The study will determine the feasibility of implementing a SCT education program (SCTaware) that is appropriate for all parents, including those with low base knowledge and low health literacy and then test if results in high and sustained SCT knowledge.

Full description

This is a single center, observational study to develop an education program for parents of young children diagnosed with Sickle Cell Trait. This will be accomplish by evaluating the current Ohio education in-person program, and assessing, through a set of questionnaires, how much participants are understanding about this diagnosis.

During phase I of the study, participants will be video-taped, and a set of questionnaires will be answer before and after education is given. This data will then be analyzed by the SCT Team in order to develop the Program.

During phase II of the study, population with the same criteria as phase I will be enrolled, however they will receive the revised "SCTaware" education. Pre and post education questionnaires will also be answered. In addition, participants during this phase will receive follow-up calls at 1 and 6 months to complete additional surveys.

In addition, the investigators will be using the Decisional Conflict Scale (DCS) to explore if parents experience decisional conflict about whether or not to obtain SCT testing and if SCTaware reduces this conflict

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult biological parents of children <3 years old with Hemoglobin S-trait identified by NBS who present for SCT education at NCH.
2. English proficiency will be required

Exclusion criteria

1. Parents who self-report that they do not have functional verbal English (report that they are not proficient) or if they request an interpreter for the education session.
2. Parents who have previously attended an education session about an abnormal hemoglobinopathy trait
3. Parents who self-report that they have a child with SCD
4. Parents who self-report that they have SCD.
5. Parents who report that they or their partner is currently pregnant

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Education

Other group

Description:

During phase 1 of this study parents who attend in person education sessions will be recruited to have their standard sessions video-taped, timed, and reviewed by the SCTaware Team. Subjects will complete before and after education questionnaires that will then be reviewed to see how much participants learned about SCT, how education was not clear and/or appropriate (too much medical jargon). The SCTaware education will then be created based on review of these videos and participants' survey responses. For phase 2 of the study, the same recruitment strategy will be utilized. Participants will receive SCTaware and complete before and after questionnaires for evaluation. Participants in this phase will also complete follow-up questionnaires at 1 and 6 months.

Treatment:

Other: Education