Sickle Cell DiseaseNCT04606160
Utilizing A Single Session Problem-Solving Intervention With Caregivers of Pediatric Patients Receiving Chronic Transfusion to Treat Sickle Cell Disease
A study testing Single Session Problem-Solving Intervention in people with Sickle Cell Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study seeks to utilize an innovative approach of a single session problem-solving intervention to address psychosocial factors affecting patient outcomes within the pediatric sickle cell population. The study will be a randomized control trial of a single session problem-solving intervention. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Single Session Problem-Solving Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English speaking
- Patient and/or caregiver of patient between the ages of 7 years to less than 19 at time of enrollment
- Patient and/or caregiver of patient diagnosis of sickle cell disease with sickle cell - SS genotype
- Patient and/or caregiver of patient who has received chronic blood transfusions for at least 6 months and continuing through the duration of the study
- Caregiver and patient pair agree to both participate in the study
Who cannot join
- Patient or caregiver of patient who are temporarily on blood transfusions for a transient complication (e.g., priapism or recurrent acute chest syndrome)
- Patient and/or caregiver of patient displaying clinically evident cognitive delay (e.g., stroke with severe cognitive deficits, intellectual disability) that would preclude completion of measures or participation in intervention as defined by the medical team, researcher, or psychologist.
- Patient and/or caregiver of patient who is a ward of state
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to utilize an innovative approach of a single session problem-solving intervention to address psychosocial factors affecting patient outcomes within the pediatric sickle cell population. The study will be a randomized control trial of a single session problem-solving intervention.
This original research will investigate the feasibility and efficacy of utilizing a single-session problem-solving intervention to address problems affecting children and families receiving chronic blood transfusions for sickle cell disease in order to: 1) contribute to literature related to single session problem solving interventions with the chronic transfusion sickle cell population and 2) identify a model of sustainable care that reduces the burden of a multiple session intervention and increases access to services. Additionally, this research aims to provide relatively low burden and potentially highly effective intervention into regular care for this population in order to evaluate the feasibility of integrating a single-session problem solving intervention into routine clinical flow, thereby addressing needs more systematically that have been identified by families. Further, this research aims to identify potential utility of medical providers being trained on providing the intervention, which could be part of a future study.
Read the detailed description
In the event that research must be completed virtually due to coronavirus (COVID-19) restrictions at the research site, an Ipad will be provided to participants by clinic staff to complete measures, through Research Electronic Data Capture (REDCap) and the intervention/control visits through a Children's Health-approved and HIPAA compliant telehealth platform. Due to continued changes in protocols, it is possible that participants may begin with in-person research and transition to virtual research, or vice versa.
Patient list for chronic blood transfusion clinic will be reviewed weekly for eligible participants. Eligible participants will be approached at the start of their routine blood transfusion (which are part of their clinical care) appointment to minimize interference from sedative medications. The researcher will explain the study and answer questions related to participation. If the caregiver and youth choose to participate, written consent (and patient assent when appropriate) will be obtained.
At visit one, both study groups will receive a baseline visit (V1), which will include completing measures, and participants will be provided a handout of community mental health resources to have for future reference if mental health needs arise. During visit two (V2), (typically occurs approximately 1 month after V1) caregivers in the intervention group will complete the Psychological Outcomes Profiles (PSYCHLOPS) measure, receive a single session problem-solving intervention to target an identified problem, and complete the Abbreviated Acceptability Rating Profile (AARP) at the end of the intervention. Problem to be targeted will be identified collaboratively by the researcher and the caregiver, after review of measures completed by the caregiver and youth participant during visit one. The control group will receive a visit from the researcher, in which the caregiver participant will complete the PSYCHLOPS measure. During visit three (V3), (typically occurs approximately 2 months after V1), both groups will complete the same measures from visit one, with the addition of all caregiver participants completing the PSYCLOPS measure. At this visit, caregivers in the intervention group will also receive a short review of the problem-solving strategy and address questions about the skill following completion of measures. The caregiver participants in the intervention group will complete the AARP at the end of the intervention review. At visit four (V4), (typically occurs approximately five months after V1) both groups will complete the same measures as visit one, in addition to the PSYCHLOPS measure, for longer-term follow up. In addition, the intervention group will complete the AARP.
Virtual alternative for all visits:
All study procedures will remain the same as stated above, except clinic staff will provide the handout of community mental health resources to participants and visits with both the Intervention Group and Control Group will be conducted through a Children's Health-approved telehealth platform.
Aims and Hypotheses
Aim 1: Determine the feasibility of utilizing a single-session problem solving intervention.
Hypothesis 1: At least 70% of participants approached for this study will agree to enroll.
Hypothesis 2: At least 70% of participants who start the study will be retained through V4.
Aim 2: Determine the acceptability of a single-session problem solving intervention.
Hypothesis 3: At least 70% of caregivers will find the single-session intervention to be acceptable at V3.
Hypothesis 4: At least 70% of caregivers will find the single-session intervention to be acceptable at V4.
Aim 3: Determine the efficacy of a single-session problem solving intervention at improving the selected problem.
Hypothesis 5: The intervention group will report a greater decrease in difficulty associated with their identified problem [Psychosocial Outcomes Profiles (PSYCHLOPS)] over time (V3 and V4) compared to those in the control group.
Hypothesis 6: The intervention group will report a greater decrease in psychosocial risk factor score [Psychosocial Assessment Tool (PAT)] over time as compared to the control group.
Hypothesis 7: The intervention group will report a greater increase in quality of life [Pediatrics Quality of Life_ Sickle Cell Disease Module (PedsQL_SCD Module)], both patient and caregiver report) over time as compared to the control group.
- Conditions
- Sickle Cell Disease
- Being tested
- Single Session Problem-Solving Intervention
- Keywords
- sickle cell disease, chronic transfusion, problem solving, single session intervention, children, pediatrics, pediatric patients, caregivers, scd, intervention, chronic blood transfusion, hematology, sickle cell
- 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.
Single Session Problem-Solving InterventionBehavioural
The intervention will be a researcher led 30-45 minute session using the problem-solving module from the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Issues (MATCH-ADTC protocol.
| Study group | Role | What they receive |
|---|---|---|
| Single Session Problem-Solving Intervention | Experimental | Participants will receive a single session problem-solving intervention during visit 2 of the 4 visit research study. During visit 3, participants will receive a review of the intervention from visit 2. During visits 1, 3, and 4, participants will complete measures. Receives: Behavioral: Single Session Problem-Solving Intervention |
| Control - Non Single Session Problem-Solving Intervention | No intervention | These participants will complete measures at visits 1,2,3, and 4. They will also receive a visit during visit 2 of the 4 visit study, where they will only complete measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of utilizing the intervention as measured by the number of participants who are eligible and enroll in the study
Feasibility of utilizing the intervention will be measured by counting the number of participants who meet the eligibility criteria and enroll in the study
Measured: Time of enrollment, approx. 2-3 days from initial recruitment attempt
Feasibility of utilizing the intervention as measured by the number of participants who enrolled and were retained through Visit 4.
Feasibility of utilizing the intervention as measured by counting the number of participants who enrolled and were retained through Visit 4.
Measured: Time of enrollment until completion of study, approx. 12 months
Secondary outcomes (2)
Acceptability of the intervention as measured by the number of participants who find an intervention to be acceptable at visit 3
Acceptability will be measured by the AARP (Abbreviated Acceptability Rating Profile) questionnaire.
AARP created to be an abbreviated form of the Intervention Rating Profile (Witt \& Elliott, 1985). The AARP (Tarnowski \& Simonian, 1992) was developed as an eight-item measure that is rated on a 6-point Likert scale ranging from one (strongly disagree) to six (strongly agree). Higher scores represent higher acceptability of the intervention. The AARP has a Cronbach's alpha of .97 (Tarnowski \& Simonian, 1992).
Measured: Following the intervention to visit 3, approx. 1 month from the intervention
Acceptability of the intervention as measured by the number of participants who find an intervention to be acceptable at visit 4
Acceptability will be measured by the AARP (Abbreviated Acceptability Rating Profile) questionnaire.
AARP created to be an abbreviated form of the Intervention Rating Profile (Witt \& Elliott, 1985). The AARP (Tarnowski \& Simonian, 1992) was developed as an eight-item measure that is rated on a 6-point Likert scale ranging from one (strongly disagree) to six (strongly agree). Higher scores represent higher acceptability of the intervention. The AARP has a Cronbach's alpha of .97 (Tarnowski \& Simonian, 1992).
Measured: Following the intervention to visit 4, approx. 4 months from the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start9 Dec 2020
- Primary completion4 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Medical Center Dallas
- Responsible party
- Principal investigator, Dennis Burchette, University of Texas Southwestern Medical Center
- Investigators
- Dennis Burchette, Principal investigator, Doctoral Student ResearcherJenna Oppenheim, PsyD, Study chair, PsychologistJulie Germann, PhD, Study chair, Psychologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606160
- Sponsor's protocol ID
- STU-2020-0181
- Status last verified
- Mar 2022
- First submitted
- 21 Oct 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared will be deidentified results of the study, including information about feasibility, acceptability, and efficacy data on use of a single session problem-solving intervention use with caregivers of pediatric patients receiving chronic transfusion to treat sickle cell disease.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing A Single Session Problem-Solving Intervention With Caregivers of Pediatric Patients Receiving Chronic Transfusion to Treat Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04606160
- Acronym / sponsor ID
- STU-2020-0181
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, chronic transfusion, problem solving, single session intervention, children, pediatrics, pediatric patients, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Children's Medical Center Dallas
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 28 Oct 2020 (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.
This study seeks to utilize an innovative approach of a single session problem-solving intervention to address psychosocial factors affecting patient outcomes within the pediatric sickle cell population. The study will be a randomized control trial of a single session problem-solving intervention.
This original research will investigate the feasibility and efficacy of utilizing a single-session problem-solving intervention to address problems affecting children and families receiving chronic blood transfusions for sickle cell disease in order to: 1) contribute to literature related to single session problem solving interventions with the chronic transfusion sickle cell population and 2) identify a model of sustainable care that reduces the burden of a multiple session intervention and increases access to services. Additionally, this research aims to provide relatively low burden and potentially highly effective intervention into regular care for this population in order to evaluate the feasibility of integrating a single-session problem solving intervention into routine clinical flow, thereby addressing needs more systematically that have been identified by families. Further, this research aims to identify potential utility of medical providers being trained on providing the intervention, which could be part of a future study.
Detailed description
In the event that research must be completed virtually due to coronavirus (COVID-19) restrictions at the research site, an Ipad will be provided to participants by clinic staff to complete measures, through Research Electronic Data Capture (REDCap) and the intervention/control visits through a Children's Health-approved and HIPAA compliant telehealth platform. Due to continued changes in protocols, it is possible that participants may begin with in-person research and transition to virtual research, or vice versa.
Patient list for chronic blood transfusion clinic will be reviewed weekly for eligible participants. Eligible participants will be approached at the start of their routine blood transfusion (which are part of their clinical care) appointment to minimize interference from sedative medications. The researcher will explain the study and answer questions related to participation. If the caregiver and youth choose to participate, written consent (and patient assent when appropriate) will be obtained.
At visit one, both study groups will receive a baseline visit (V1), which will include completing measures, and participants will be provided a handout of community mental health resources to have for future reference if mental health needs arise. During visit two (V2), (typically occurs approximately 1 month after V1) caregivers in the intervention group will complete the Psychological Outcomes Profiles (PSYCHLOPS) measure, receive a single session problem-solving intervention to target an identified problem, and complete the Abbreviated Acceptability Rating Profile (AARP) at the end of the intervention. Problem to be targeted will be identified collaboratively by the researcher and the caregiver, after review of measures completed by the caregiver and youth participant during visit one. The control group will receive a visit from the researcher, in which the caregiver participant will complete the PSYCHLOPS measure. During visit three (V3), (typically occurs approximately 2 months after V1), both groups will complete the same measures from visit one, with the addition of all caregiver participants completing the PSYCLOPS measure. At this visit, caregivers in the intervention group will also receive a short review of the problem-solving strategy and address questions about the skill following completion of measures. The caregiver participants in the intervention group will complete the AARP at the end of the intervention review. At visit four (V4), (typically occurs approximately five months after V1) both groups will complete the same measures as visit one, in addition to the PSYCHLOPS measure, for longer-term follow up. In addition, the intervention group will complete the AARP.
Virtual alternative for all visits:
All study procedures will remain the same as stated above, except clinic staff will provide the handout of community mental health resources to participants and visits with both the Intervention Group and Control Group will be conducted through a Children's Health-approved telehealth platform.
Aims and Hypotheses
Aim 1: Determine the feasibility of utilizing a single-session problem solving intervention.
Hypothesis 1: At least 70% of participants approached for this study will agree to enroll.
Hypothesis 2: At least 70% of participants who start the study will be retained through V4.
Aim 2: Determine the acceptability of a single-session problem solving intervention.
Hypothesis 3: At least 70% of caregivers will find the single-session intervention to be acceptable at V3.
Hypothesis 4: At least 70% of caregivers will find the single-session intervention to be acceptable at V4.
Aim 3: Determine the efficacy of a single-session problem solving intervention at improving the selected problem.
Hypothesis 5: The intervention group will report a greater decrease in difficulty associated with their identified problem [Psychosocial Outcomes Profiles (PSYCHLOPS)] over time (V3 and V4) compared to those in the control group.
Hypothesis 6: The intervention group will report a greater decrease in psychosocial risk factor score [Psychosocial Assessment Tool (PAT)] over time as compared to the control group.
Hypothesis 7: The intervention group will report a greater increase in quality of life [Pediatrics Quality of Life_ Sickle Cell Disease Module (PedsQL_SCD Module)], both patient and caregiver report) over time as compared to the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Session Problem-Solving Intervention | Experimental | Behavioral: Single Session Problem-Solving InterventionParticipants will receive a single session problem-solving intervention during visit 2 of the 4 visit research study. During visit 3, participants will receive a review of the intervention from visit 2. During visits 1, 3, and 4, participants will complete measures. |
| Control - Non Single Session Problem-Solving Intervention | No intervention | –These participants will complete measures at visits 1,2,3, and 4. They will also receive a visit during visit 2 of the 4 visit study, where they will only complete measures. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- English speaking
- Patient and/or caregiver of patient between the ages of 7 years to less than 19 at time of enrollment
- Patient and/or caregiver of patient diagnosis of sickle cell disease with sickle cell - SS genotype
- Patient and/or caregiver of patient who has received chronic blood transfusions for at least 6 months and continuing through the duration of the study
- Caregiver and patient pair agree to both participate in the study
Key exclusion criteria (3 listed)
- Patient or caregiver of patient who are temporarily on blood transfusions for a transient complication (e.g., priapism or recurrent acute chest syndrome)
- Patient and/or caregiver of patient displaying clinically evident cognitive delay (e.g., stroke with severe cognitive deficits, intellectual disability) that would preclude completion of measures or participation in intervention as defined by the medical team, researcher, or psychologist.
- Patient and/or caregiver of patient who is a ward of state
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 |
|---|---|---|
| Single Session Problem-Solving InterventionThe intervention will be a researcher led 30-45 minute session using the problem-solving module from the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Issues (MATCH-ADTC protocol. | Behavioural | Single Session Problem-Solving Intervention |
Primary outcome
Feasibility of utilizing the intervention as measured by the number of participants who are eligible and enroll in the study
Time frame: Time of enrollment, approx. 2-3 days from initial recruitment attempt
Feasibility of utilizing the intervention will be measured by counting the number of participants who meet the eligibility criteria and enroll in the study
Feasibility of utilizing the intervention as measured by the number of participants who enrolled and were retained through Visit 4.
Time frame: Time of enrollment until completion of study, approx. 12 months
Feasibility of utilizing the intervention as measured by counting the number of participants who enrolled and were retained through Visit 4.
2 secondary outcomes
Acceptability of the intervention as measured by the number of participants who find an intervention to be acceptable at visit 3
Time frame: Following the intervention to visit 3, approx. 1 month from the intervention
Acceptability of the intervention as measured by the number of participants who find an intervention to be acceptable at visit 4
Time frame: Following the intervention to visit 4, approx. 4 months from the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: Yes. Data to be shared will be deidentified results of the study, including information about feasibility, acceptability, and efficacy data on use of a single session problem-solving intervention use with caregivers of pediatric patients receiving chronic transfusion to treat sickle cell disease.
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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. This study is not recruiting at the moment.
Dennis Burchette principal investigator
Doctoral Student Researcher
Jenna Oppenheim, PsyD study chair
Psychologist
Julie Germann, PhD study chair
Psychologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Session Problem-Solving Intervention in people with Sickle Cell Disease, run by University of Texas Southwestern Medical Center at 1 site 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 5 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: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of utilizing the intervention as measured by the number of participants who are eligible and enroll in the study (time frame: Time of enrollment, approx. 2-3 days from initial recruitment attempt). The study lists 2 primary outcomes in all. 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 21 Mar 2022.