Sickle Cell DiseaseI-STRONG SCDNCT06691867
Integrative Training Program for Pediatric Sickle Cell Pain
A study testing I-STRONG in people with Sickle Cell Disease, run by Emory University at 4 sites in United States.
Trial summary
This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms? The program will be tailored to address challenges related to… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- I-STRONG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jan 2025to Aug 2027
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provision of signed and dated informed consent form for adolescents 18 years old and caregivers' participation
- For children <18, informed assent and parental informed consent to participate in the study
- Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Males and females; Ages 12-18 years for adolescents; no age limitations for caregivers
- Documented diagnosis of sickle cell disease (any genotype) for adolescents
- Adolescent scores at least 3 on the Pediatric Pain Screening Tool
Show all 9Show fewer
- Adolescent reports typical pain intensity in the past week at least 4 on a 0-10 cm Visual Analog Scale
- Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea, glutamine, voxelotor, crizanlizumab) as defined by not newly initiated or significantly increased dosages (mg/kg) in the past 3 months
- Speak and read English
Who cannot join
- An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
- Adolescent has undergone genetic or hematopoietic stem cell therapy
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation
- Adolescents receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g., structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
- Recruiting
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial
This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms?
The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health.
The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program.
Read the detailed description
I-STRONG for SCD integrates evidence-based mind-body, cognitive-behavioral, and neuromuscular movement training. It will be tested using an individually randomized group treatment (IRGT) design, comparing early start to the enhanced usual care. The primary objective is to determine whether I-STRONG for SCD combined with standard care is more effective than standard care alone in improving pain intensity from baseline to the 3-month follow-up in adolescents with SCD.
Adolescent participants with sickle cell disease and their caregivers will be recruited for this study. Participants of all genders, races, and ethnicities are eligible, with a majority expected to be Black or African American females, consistent with previous studies of individuals with SCD and chronic pain. The study will last approximately 36 months, with participant involvement lasting 9 months.
I-STRONG for SCD has been adapted from the Fibromyalgia Integrative Training for Teens (FIT Teens) program based on feedback from patients and caregivers, focusing on chronic SCD pain. In addition to usual care, participants will receive the I-STRONG intervention, which consists of 16 group-based telehealth sessions (90 minutes each), held twice weekly for 8 weeks. All patients can participate in I-STRONG, with randomization determining whether they begin with Early Start (after completing the baseline assessment) or Enhanced Usual Care (approximately 8 months after the baseline assessment).
Support from and inclusion in the National Institutes of Health (NIH) Helping to End Addiction Long-term Initiative (HEAL), or NIH HEAL Initiative, is provided for this study. For more information about the initiative visit the HEAL Initiative (https://heal.nih.gov/).
- Conditions
- Sickle Cell Disease
- Being tested
- I-STRONG, Enhanced Usual Care (EUC)
- Keywords
- Sickle Cell Pain, Lifestyle considerations, Pediatrics, Behavioral intervention, Mind-body intervention
- 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.
I-STRONGBehavioural
Also called Intervention Group
I-STRONG is an evidence-based protocol from the FIT Teens program. This intervention combines mind-body and cognitive-behavioral approaches with neuromuscular movement training informed by pediatric sports medicine and injury prevention research. It aims to teach mind-body skills applicable during movement training to enhance psychological coping and reduce fear of pain and activity avoidance.
I-STRONG consists of 16 group-based telehealth sessions held twice weekly over 8 weeks. Each group can accommodate up to 6 patients with SCD. Adolescents are expected to attend all sessions, while parents will attend 6 of the 16. Parents will receive education about I-STRONG, guidance on supporting their teen's behavior change, and opportunities for networking with other parents of youth with SCD. Sessions will include brief daily homework (e.g., using phone apps to practice skills) to facilitate proficiency. Participants will self-report their practice of assigned skills.
Enhanced Usual Care (EUC)Other
Also called Control Group
The EUC arm is designed to account for potential effects on time and standard medical care outcomes. Patients randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months (i.e., time from enrollment through 6-month post-treatment assessment) before starting the intervention program to coincide with the study duration of the ES arm. After completing the 6-month follow-up assessment, patients will have the opportunity to start the I-STRONG for SCD intervention.
| Study group | Role | What they receive |
|---|---|---|
| I-STRONG - Early Start | Experimental | Youth and caregivers will receive the I-STRONG for SCD intervention in addition to standard care. Receives: Behavioral: I-STRONG |
| Enhanced Usual Care (EUC) | Other | Participants randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months. After completing the 6-month follow-up assessment, participants will have the opportunity to start the I-STRONG SCD intervention. Receives: Other: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI) Pain severity
Pain intensity is rated with the pain severity item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10.
This outcome applies to teens only.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Secondary outcomes (16)
Change in Brief Pain Inventory (BPI) Pain Interference Score
Functional interference due to pain rated with the impact of pain on daily functions item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10.
This outcome applies to teens only.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Patient Health Questionnaire (PHQ-8) Score
Depressive symptoms in past two weeks among teen study participants and parents is assessed with the Patient Health Questionnaire (PHQ-8). The PHQ-8 has 8 items that are responded to on a 4-point scale where " not at all" = 0 and "nearly every day" = 3. Total scores range from 0 to 24 where higher scores indicate increased symptoms of depression.
The outcome applies to teens and parents.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
General Anxiety Disorder (GAD-2)
General worry in the past two weeks among teen study participants and parents will be assessed using the GAD-2 instrument. The GAD-2 has 2 items that are responded to on a 4-point scale where " not at all" = 0 and "nearly every day" = 3. Total scores range from 0 to 6 where higher scores indicate increased experiences of worry.
The outcome applies to teens and parents.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Pain Catastrophizing Scale
Exaggerated worried thoughts of pain will be assessed among teen study participants and parents. The Pain Catastrophizing Scale, Child and Parent Report, is a 13-item well-validated self-report and parent-report measure of worried thoughts about pain. Items are answered on a 5-point scale where 0 = not true at all and 4 = very true. Total scores range from 0 to 52 and higher scores indicate increased catastrophic thinking.
The outcome applies to teens and parents.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Pediatric Quality of Life Inventory (PedsQL) Score
Health-related quality of life and impact on child and family in the past month is assessed among teen study participants and parents with the Pediatric Quality of Life Inventory (PedsQL). The 23-item PedsQL was developed as part of the NIH Roadmap Initiative to create universal measures for patient-reported outcomes and contains questions in the domains of social peer, depression, anxiety, mobility, and function. Responses are given on a 5-point scale where 0 = never and 4 = almost always. Items are reverse scored and linearly transformed to a scale of 0 to 100, where higher total mean scores indicate a better quality of life.
The outcome applies to teens only.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Adolescent Sleep-Wake Scale (ASWS) Score Short Form
The Adolescent Sleep Wake Scale (ASWS) Short Form is a 14-item patient report describing the occurrence and frequency of various behavioral sleep characteristics over the past month. Responses are given on a 6-point Likert scale where 1 = always and 6 = never. Total scores range from 14 to 84 and higher scores indicate better sleep quality.
This outcome applies to teens only.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2 score
Substance use among teen study participants during the past 3 months is assessed with the NIDA-Modified Assist Tool Level 2 for children aged 11-17. The instrument asks respondents how often they have used 15 different substances. Responses are given on a 4-point scale where "not at all" = 0 and "nearly every day" = 4. The tool is scored as the number of items with a score greater than 0 and multiple items with scores above 0 indicate increased substance use.
This outcome applies to teens only.
Measured: Baseline, 3 months post-intervention
Opioid Use
Daily use of opioid pain medication will be determined based on participant completion of daily diaries for 1-week at each assessment visit. Participants will record opioid use daily (yes/no).
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Opioid morphine milligram equivalent Use
An electronic medical chart review will determine opioid morphine milligram equivalent (MME) calculation in the past month, with higher scores indicating higher MME per day.
Measured: Baseline and 3 months post-intervention
Patient Global Impression of Change (PGIC) Score
The overall self-reported rating of the treatment's efficacy will be assessed with the Patient's Global Impression of Change (PGIC) instrument. The PGIC asks respondents to rate their overall improvement compared to the baseline. Responses are indicated on a scale of 1 to 7, where 1 = very much improved and 7 = very much worse.
This outcome applies to teens only.
Measured: Baseline, 3 months and 6 months post-intervention
Treatment Evaluation Inventory-Short Form (TEI-SF) Score
Teens and parents will complete the Treatment Evaluation Inventory-Short Form at the end of treatment. This form includes 9 items adapted to be specific to pediatric pain. Items are rated on a 5-point Likert scale ranging from 1 to 5. Total scores range from 9 to 45. Higher scores indicate increased acceptability with the study treatment.
This outcome applies to teens and parents
Measured: Immediately post-intervention
Tampa Scale of Kinesiophobia (TSK) Score
Fear of movement related to fear of pain is assessed with the Tampa Scale of Kinesiophobia (TSK) instrument. The TSK is a 17-item questionnaire where responses are given on a 4-point Likert scale. Responses of "strongly agree" are coded as 1 and responses of "strongly agree" are coded as 4. Total scores range from 17 to 68 where higher scores indicate greater kinesiophobia.
This outcome applies to teens only.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
PROMIS Pediatric Fatigue Short Form
Perceptions of a child's tiredness and energy will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Fatigue Short Form. It consists of 10 items scored on a Likert-type scale ranging from 1 (never) to 5 (almost always). The total possible range is 10-50, with higher scores representing greater fatigue or lower energy, while lower scores indicate better energy levels or less fatigue.
The outcome applies to teens and parent-proxy.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Chronic Pain Acceptance Questionnaire (CPAQ)
The 20-item CPAQ-revised has been designed to measure acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). To score the CPAQ, the Activity engagement and Pain willingness items are added to obtain a score for each factor. All the scores for each factor are summed to get the total score. Higher scores indicate higher levels of acceptance.
The outcome applies to teens only.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Coping Self-Efficacy
The Child Self-Efficacy Scale (CSES) is a self-report tool that examines self-efficacy despite pain to assess normal functioning and behavior. The CSES is a 7-item form asking how sure a child can perform certain activities while in pain. An 11-point scale with anchor points being 0 (cannot do at all), 5 (moderately certain can do), and 10 (certain can do). A higher score suggests that a person is more confident in their ability to cope and function with pain.
The outcome applies to teens and parent-proxy.
Measured: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Therapeutic Factor Inventory - 8 (TFI-8)
TFI-8 is a brief, reliable, and valid measure used for continuous process measurement and feedback to improve the functioning of therapy groups. The TFI-8 is given to participants after group therapy sessions to assess group cohesion. It typically consists of 8 items that respondents rate based on their experiences. Participants usually respond using a Likert scale (e.g., 1 to 5), where 1 may indicate "strongly disagree" and 5 indicates "strongly agree." The total score is calculated by summing the responses for all items. Higher total scores generally indicate a greater presence of therapeutic factors perceived by the participants.
The outcome applies to teens only.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start8 Jan 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
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.
- More trials run by Emory UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Soumitri Sil, Emory University
- Investigators
- Soumitri Sil, PhD, ABPP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691867
- Sponsor's protocol ID
- STUDY00008060
- Other IDs
- R33AT012421, 2024P007498
- Acronym
- I-STRONG SCD
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2024
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be available for sharing including study-level metadata and NIH Helping to End Addiction Long-term (HEAL) Common Data Elements.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06691867
- Acronym / sponsor ID
- I-STRONG SCD / STUDY00008060
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Pain, Lifestyle considerations, Pediatrics, Behavioral intervention, Mind-body intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Nov 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.
This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms?
The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health.
The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program.
Detailed description
I-STRONG for SCD integrates evidence-based mind-body, cognitive-behavioral, and neuromuscular movement training. It will be tested using an individually randomized group treatment (IRGT) design, comparing early start to the enhanced usual care. The primary objective is to determine whether I-STRONG for SCD combined with standard care is more effective than standard care alone in improving pain intensity from baseline to the 3-month follow-up in adolescents with SCD.
Adolescent participants with sickle cell disease and their caregivers will be recruited for this study. Participants of all genders, races, and ethnicities are eligible, with a majority expected to be Black or African American females, consistent with previous studies of individuals with SCD and chronic pain. The study will last approximately 36 months, with participant involvement lasting 9 months.
I-STRONG for SCD has been adapted from the Fibromyalgia Integrative Training for Teens (FIT Teens) program based on feedback from patients and caregivers, focusing on chronic SCD pain. In addition to usual care, participants will receive the I-STRONG intervention, which consists of 16 group-based telehealth sessions (90 minutes each), held twice weekly for 8 weeks. All patients can participate in I-STRONG, with randomization determining whether they begin with Early Start (after completing the baseline assessment) or Enhanced Usual Care (approximately 8 months after the baseline assessment).
Support from and inclusion in the National Institutes of Health (NIH) Helping to End Addiction Long-term Initiative (HEAL), or NIH HEAL Initiative, is provided for this study. For more information about the initiative visit the HEAL Initiative (https://heal.nih.gov/).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-STRONG - Early Start | Experimental | Behavioral: I-STRONGYouth and caregivers will receive the I-STRONG for SCD intervention in addition to standard care. |
| Enhanced Usual Care (EUC) | Other | Other: Enhanced Usual Care (EUC)Participants randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months. After completing the 6-month follow-up assessment, participants will have the opportunity to start the I-STRONG SCD intervention. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form for adolescents 18 years old and caregivers' participation
- For children <18, informed assent and parental informed consent to participate in the study
- Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Males and females; Ages 12-18 years for adolescents; no age limitations for caregivers
- Documented diagnosis of sickle cell disease (any genotype) for adolescents
Key exclusion criteria (4 listed)
- An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
- Adolescent has undergone genetic or hematopoietic stem cell therapy
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation
- Adolescents receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g., structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention
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 |
|---|---|---|
| I-STRONGAlso: Intervention GroupI-STRONG is an evidence-based protocol from the FIT Teens program. This intervention combines mind-body and cognitive-behavioral approaches with neuromuscular movement training informed by pediatric sports medicine and injury prevention research. It aims to teach mind-body skills applicable during movement training to enhance psychological coping and reduce fear of pain and activity avoidance. I-STRONG consists of 16 group-based telehealth sessions held twice weekly over 8 weeks. Each group can accommodate up to 6 patients with SCD. Adolescents are expected to attend all sessions, while parents will attend 6 of the 16. Parents will receive education about I-STRONG, guidance on supporting their teen's behavior change, and opportunities for networking with other parents of youth with SCD. Sessions will include brief daily homework (e.g., using phone apps to practice skills) to facilitate proficiency. Participants will self-report their practice of assigned skills. | Behavioural | I-STRONG - Early Start |
| Enhanced Usual Care (EUC)Also: Control GroupThe EUC arm is designed to account for potential effects on time and standard medical care outcomes. Patients randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months (i.e., time from enrollment through 6-month post-treatment assessment) before starting the intervention program to coincide with the study duration of the ES arm. After completing the 6-month follow-up assessment, patients will have the opportunity to start the I-STRONG for SCD intervention. | Other | Enhanced Usual Care (EUC) |
Primary outcome
Brief Pain Inventory (BPI) Pain severity
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Pain intensity is rated with the pain severity item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10. This outcome applies to teens only.
16 secondary outcomes
Change in Brief Pain Inventory (BPI) Pain Interference Score
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Patient Health Questionnaire (PHQ-8) Score
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
General Anxiety Disorder (GAD-2)
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Pain Catastrophizing Scale
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Pediatric Quality of Life Inventory (PedsQL) Score
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Adolescent Sleep-Wake Scale (ASWS) Score Short Form
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2 score
Time frame: Baseline, 3 months post-intervention
Opioid Use
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Opioid morphine milligram equivalent Use
Time frame: Baseline and 3 months post-intervention
Patient Global Impression of Change (PGIC) Score
Time frame: Baseline, 3 months and 6 months post-intervention
Treatment Evaluation Inventory-Short Form (TEI-SF) Score
Time frame: Immediately post-intervention
Tampa Scale of Kinesiophobia (TSK) Score
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
PROMIS Pediatric Fatigue Short Form
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Coping Self-Efficacy
Time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Therapeutic Factor Inventory - 8 (TFI-8)
Time frame: Immediately post-intervention
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 14 Nov 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be available for sharing including study-level metadata and NIH Helping to End Addiction Long-term (HEAL) Common Data Elements.
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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.
Soumitri Sil, PhD, ABPP principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-STRONG in people with Sickle Cell Disease, run by Emory University 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 9 inclusion and 4 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 14 Nov 2025. 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. 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 Soumitri Sil, PhD, ABPP (404-727-2712, sil@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) Pain severity (time frame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention). 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 14 Nov 2025.