Anemia, Sickle CellSC-ThriveNCT06290401
A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
A study testing SCThrive and SCHealthED in people with Anemia, Sickle Cell, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4… Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- SCThrive and SCHealthED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Feb 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient of a participating SCD Clinic
- Confirmed diagnosis of SCD
- 13-21 years of age
Who cannot join
- Another chronic disease (which would complicate measurement of patient activation)
- Non-English-speaking
- Cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taylor Richardson, BA contact
United States4 sites, 4 recruiting
- Not yet recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30303
Vontarius Howard, 404-785-3245, Vontarius.Howard@choa.org
Soumitri Sil, PhD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Lori Crosby, PsyD, 513-636-5380, lori.crosby@cchmc.org
Ama Wilson, MPH, 513-803-0917, ama.wilson@cchmc.org
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Polina Poliakova, 267-426-0355, poliakovap@chop.edu
Lisa Schwartz, PhD
- Not yet recruiting
Nemours Children's Health
Wilmington, Delaware, 19803
Benjamin Bear, MSW, 302-723-9331, benjamin.bear@nemours.org
Aimee Hildenbrand, PhD
About this study
The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.
The main question[s]it aims to answer are:
Read more
- Does SCThrive improve patient activation?
- Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?
- Are any improvements maintained 3 months after treatment?
Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).
Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.
Read the detailed description
The research team's pilot work demonstrated improved patient activation (knowledge, skills, and self-efficacy) and self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD) compared to a control condition. Further analyses revealed that participants who used the app more frequently showed greater improvements. Thus, this study will maximize the clinical benefit of SCThrive by 1) adding app engagement strategies, 2) conducting a more systematic assessment of barriers including social contributors to health, and 3) integrating ways to address these barriers into the intervention.
Study Aims: The aims are to examine the impact of SCThrive on patient activation (primary outcome; Aim 1) and self-management behaviors, daily functioning, and emergency room visits (secondary outcomes) at post-treatment and follow-up (Aim 2). It is hypothesized that adolescents randomized to SCThrive will have greater improvement in patient activation (primary outcome) compared to those randomized to uniform standard care (control condition). The research team will also explore the relationship between social determinants of health (SDOH)-related barriers (e.g., stigma, access to care) and treatment response (i.e., patient activation and self-management behaviors).
- Conditions
- Anemia, Sickle Cell
- Being tested
- SCThrive, SCHealthED
- Keywords
- adolescent and young adult (AYA), self-management, behavioral intervention, sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCThriveBehavioural
SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.
SCHealthEDOther
Also called Uniform Standard Care
Standard of care plus 7 SCD educational text messages to ensure education is uniform across sites
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app. Receives: Behavioral: SCThrive |
| Control Condition | Placebo comparator | Participants randomized to SCHealthED will receive usual care plus 7 text messages consisting of SCD educational facts to ensure the care is uniform across sites. Receives: Other: SCHealthED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation
Self-reported patient activation as measured by the Patient Activation Measure -13 (PAM-13), which is a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005. Items are rated on a 4-point Likert scale of 1 = "Disagree Strongly" to 3 = "Strongly Agree." Raw scores range from 13 to 52 and are converted to scores that range from 0 to 100. This score was then divided into four levels of activation, which reflect a developmental progression from being passive with regard to one's health to being proactive: Level 1 (score of 0.0 - 47.0), Level 2 (47.1 - 55.1), Level 3 (55.2 - 72.4), and Level 4 (72.5 - 100). Higher scores indicate more behavioral activation.
Measured: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Secondary outcomes (5)
Self-Management Behaviors
self-reported self-management behaviors as measured by the Transition Readiness Assessment Questionnaire - 6 (TRAQ-6), which is a well-validated 20-item questionnaire that measures the skills needed to manage a chronic condition independently. Items are rated on a 5-point Likert scale of 1 = "No, I do not know how" to 5 = "Yes, I always do this when I need to" and divided into 5 subscales: Managing Medication, Appointment Keeping, Tracking Health Issues, Talking with Providers, and Managing Daily Activities. Overall and subscale scores are calculated by averaging the scores of answered items. Mean scores range from 1 to 5 with higher scores indicating better self-management.
Measured: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Daily Functioning
The Functional Disability Inventory is a self-report measure of limitations in children's physical and psychosocial functioning due to their physical health. The instrument consists of 15 items concerning activity limitations due to "being sick or not feeling well" during the past 2 weeks. Total scores ranging from 0 to 60 are computed by summing the ratings for each of the 15 items on the FDI. Higher scores indicate greater perceived functional disability.
Measured: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Emergency Room (ER) Visits
number of emergency room visits
Measured: 6 months prior to treatment; 6 months post-treatment
Self-Management Skills
Participants complete the UNC TRxANSITION Scale, an interview administered by trained independent evaluators to measure the skills of youth with chronic conditions. For this study, we will administer 6 of the 10 possible subscales: Type of Chronic Health Condition, Medications, Adherence, Nutrition, Self-Management Skills, and New Health Care Providers. Each item is scored individually as either 1 (adequate knowledge/skill mastery), 0.5 (some knowledge/skill attainment), or 0 (no knowledge/skill attainment). Higher scores indicate better self-management. Subscale scores are calculated by dividing the patient's score by the total possible subscale score. Subscale scores are then combined to create a total score, ranging from 0 to 10, but since we will only use 6 scales, 0 to 6. Total and subscale proportion scores will be used in analyses.
Measured: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Health-related quality of life
Patient report of sickle cell disease (SCD)-specific quality of life (QOL) and pain, as measured by the Pediatric Quality of Life (PedsQL) SCD Module, which assesses several domains of health-related quality of life (HRQOL), including pain impact, fatigue, pain management, emotions, communication, and treatment adherence. Total score only. Scores range from 0 to 100, with higher scores indicating higher HRQOL or higher functioning.
Measured: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 Feb 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated to SCThrive or SCHealthED (uniform standard care) using a randomized block design for age group (13-17 years of age or 18-21 years of age) with a predefined block size of 4.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Nemours Children's Health System, Emory University, Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Lori E. Crosby, PsyD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290401
- Sponsor's protocol ID
- 2023-0671
- Acronym
- SC-Thrive
- Status last verified
- May 2026
- First submitted
- 15 Feb 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified data will be shared with other researchers. Deidentified data sets will be available on the Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
- ClinicalTrials.gov ID
- NCT06290401
- Acronym / sponsor ID
- SC-Thrive / 2023-0671
- Conditions
- Anemia, Sickle Cell
- Keywords
- adolescent and young adult (AYA), self-management, behavioral intervention, sickle cell disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Nemours Children's Health System, Emory University, Children's Hospital of Philadelphia
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.
The main question[s]it aims to answer are:
- Does SCThrive improve patient activation?
- Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?
- Are any improvements maintained 3 months after treatment?
Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).
Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.
Detailed description
The research team's pilot work demonstrated improved patient activation (knowledge, skills, and self-efficacy) and self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD) compared to a control condition. Further analyses revealed that participants who used the app more frequently showed greater improvements. Thus, this study will maximize the clinical benefit of SCThrive by 1) adding app engagement strategies, 2) conducting a more systematic assessment of barriers including social contributors to health, and 3) integrating ways to address these barriers into the intervention.
Study Aims: The aims are to examine the impact of SCThrive on patient activation (primary outcome; Aim 1) and self-management behaviors, daily functioning, and emergency room visits (secondary outcomes) at post-treatment and follow-up (Aim 2). It is hypothesized that adolescents randomized to SCThrive will have greater improvement in patient activation (primary outcome) compared to those randomized to uniform standard care (control condition). The research team will also explore the relationship between social determinants of health (SDOH)-related barriers (e.g., stigma, access to care) and treatment response (i.e., patient activation and self-management behaviors).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be allocated to SCThrive or SCHealthED (uniform standard care) using a randomized block design for age group (13-17 years of age or 18-21 years of age) with a predefined block size of 4.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Behavioral: SCThriveSCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app. |
| Control Condition | Placebo comparator | Other: SCHealthEDParticipants randomized to SCHealthED will receive usual care plus 7 text messages consisting of SCD educational facts to ensure the care is uniform across sites. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient of a participating SCD Clinic
- Confirmed diagnosis of SCD
- 13-21 years of age
Key exclusion criteria (3 listed)
- Another chronic disease (which would complicate measurement of patient activation)
- Non-English-speaking
- Cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCThriveSCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app. | Behavioural | Active Treatment |
| SCHealthEDAlso: Uniform Standard CareStandard of care plus 7 SCD educational text messages to ensure education is uniform across sites | Other | Control Condition |
Primary outcome
Patient Activation
Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Self-reported patient activation as measured by the Patient Activation Measure -13 (PAM-13), which is a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005. Items are rated on a 4-point Likert scale of 1 = "Disagree Strongly" to 3 = "Strongly Agree." Raw scores range from 13 to 52 and are converted to scores that range from 0 to 100. This score was then divided into four levels of activation, which reflect a developmental progression from being passive with regard to one's health to being proactive: Level 1 (score of 0.0 - 47.0), Level 2 (47.1 - 55.1), Level 3 (55.2 - 72.4), and Level 4 (72.5 - 100). Higher scores indicate more behavioral activation.
5 secondary outcomes
Self-Management Behaviors
Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Daily Functioning
Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Emergency Room (ER) Visits
Time frame: 6 months prior to treatment; 6 months post-treatment
Self-Management Skills
Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Health-related quality of life
Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. Only de-identified data will be shared with other researchers. Deidentified data sets will be available on the Open Science Framework.
Related trials for Anemia, Sickle Cell
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taylor Richardson, BA contact
Lori E. Crosby, PsyD principal investigator
Children's Hospital Medical Center, Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCThrive and SCHealthED in people with Anemia, Sickle Cell, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ama Wilson, MPH (15136365380, Ama.Wilson@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.