Brief Title
Pilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
Official Title
Pilot Evaluation of a Telehealth Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
Brief Summary
Sickle cell disease (SCD) is a group of inherited blood disorders affecting 100,000
individuals in the United States. SCD often leads to complications, including pain crises and
organ damage. Many individuals with SCD require medications (e.g., Hydroxyurea or Endari)
that research has demonstrated reduce risk of complications and improve quality of life.
Despite the need for strong medication adherence, adolescents and young adults (AYAs; 13-25
years) have the lowest adherence rates compared to other age groups. Efforts to reduce AYA
non-adherence risk should include youth in earlier childhood and persist throughout the AYA
developmental period, with the goal of maintaining adherence throughout childhood and young
adulthood. Motivational Interviewing (MI) has been effective in increasing pediatric and
adult medication adherence via in-person or telehealth delivery; however, researchers have
yet to empirically evaluate MI for feasibility, acceptability, and/or efficacy in improving
pediatric/AYA SCD medication adherence. The proposed feasibility trial will provide
preliminary feasibility data for a newly developed MI+education intervention targeting
medication adherence for pediatric and adolescents and young adults (AYA) patients who have
sickle cell disease. This trial will also evaluate study design feasibility to inform a
future randomized controlled trial (RCT). The investigators are interested in delivering the
intervention to AYA patients and to parents of younger children who have sickle cell disease
because the investigators anticipate that establishing strong adherence in younger childhood
could prevent future non-adherence during the AYA developmental period. Participants will
include 13-22 year-old patients with sickle cell disease as well as parents of 0-22 year-old
patients with sickle cell disease. The investigators will randomize ten families to a
4-session telehealth MI+education intervention and five families to a one-session
education-only control condition. All participants will complete assessments at three times.
Intervention participants will complete the T2 assessment at their last intervention session
(week 4-8), and the T3 assessment 16-20 weeks after study enrollment. Education arm
participants will complete T2 assessments 4-8 weeks after study enrollment and will complete
T3 assessments 16-20 weeks after study enrollment. Primary outcomes include intervention
feasibility and acceptability and study design feasibility.
Study Type
Interventional
Primary Outcome
Change in sickle cell disease medication adherence
Secondary Outcome
Change in sickle cell disease knowledge as assessed by the Sickle-Cell Disease Knowledge Questionnaire
Condition
Sickle Cell Disease
Intervention
Adherence Treatment Program
Study Arms / Comparison Groups
Intervention Arm
Description: Intervention sessions will occur ~once per week, with all 4 sessions being completed within 4-8 weeks. Each session will include an education and motivational interviewing (MI) component.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
16
Start Date
December 30, 2021
Completion Date
August 1, 2022
Primary Completion Date
June 30, 2022
Eligibility Criteria
Inclusion Criteria:
- Participants will include 13-22 year-old patients with sickle cell disease as well as
primary caregivers of 0-22 year-old sickle cell disease patients ("parents"). The
lower age limit for patients' participation in their own intervention sessions was
selected based on previous studies documenting MI effectiveness with adolescents as
young as 13 years of age. The upper limit was selected based on the recruitment site's
(JHACH) patient population.
- Participants must be able to speak and understand spoken English because MI is
language-dependent.
- The patient's SCD regimen must include at least one of the following medications:
Hydroxyurea, Endari, Adakveo, or Oxbryta.
- Patients who meet inclusion criteria may participate even if their parent chooses not
to do so, although 13-17 year old patients may only participate with parent consent.
Likewise, parents of patients may participate even if the AYA declines their own
participation, as long as the AYA assents/consents to medical chart review. Adult
patients (18-22 years of age) will not require parent consent and may choose to
participate with or without a parent.
Exclusion Criteria:
- Potential participants who appear to have cognitive, motor, or language delays, as
observed by research personnel or documented in the medical record, will be excluded
from this study if delays preclude informed consent and/or study completion.
Participants may request that research personnel read all assessment, education, and
intervention materials aloud in a structured interview format, in which case
participants could respond to items verbally and/or by pointing to visual aids.
Because of this option, participants' ability to read and write are not requirements
for participation.
- Because the MI component of the intervention is language-dependent and requires
significant time and training for certification in another language, non-English
speaking patients will only be included in this study if the psychology postdoctoral
fellow hired in this study is a native Spanish speaker and can demonstrate MI
proficiency in Spanish.
- Participants who score in the clinically significant range (t-scores 2 standard
deviations above the mean) on any of the PROMIS measures assessing depression and
anxiety will be removed from the study and provided mental health resources.
Gender
All
Ages
13 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Melissa Faith, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04877054
Organization ID
IRB00285183
Responsible Party
Sponsor
Study Sponsor
Johns Hopkins All Children's Hospital
Study Sponsor
Melissa Faith, Principal Investigator, Johns Hopkins All Children's Hospital
Verification Date
August 2022