Clinical trial NCT03984500: A Program to Increase Sickle Cell Trait Knowledge Among Parent of Young Children Identified in Newborn Screening
Official title: A Comprehensive Program to Increase Sickle Cell Trait Knowledge and Awareness Among Parents of Young Children Identified in Newborn Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Trait
Keywords: Sickle Cell Trait
Education
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-06-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of implementing of a Sickle Cell Trait education Program: The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured
timeFrame: 2 years
measure: Parental Sickle Cell Trait Knowledge
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of Parents who receive on-site Sickle Cell Trait testing
timeFrame: 2 years
measure: Decisional Conflict Scale
timeFrame: 2 years
measure: Parental Anxiety
timeFrame: 2 years
measure: Sickle Cell Trait Testing Cost
timeFrame: 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Susan Creary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abrams MA, Zajo KN, Beeman CM, O'Brien SH, Chan PK, Shen Y, McCorkle B, Johnson L, Chisolm D, Barnard-Kirk T, Mahan JD, Christian-Rancy M, Creary SE. A Health Literate Approach to Address Health Disparities: a Virtual Program for Parents of Children with Sickle Cell Trait. J Commun Healthc. 2022;15(2):112-120. doi: 10.1080/17538068.2022.2026056. Epub 2022 Jan 19.