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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| Emory University | OTHER |
| Connecticut Children's Medical Center | OTHER |
| University of Mississippi Medical Center |
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The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.
Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education Control | Active Comparator | In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks. |
|
| Pain Self-Management Intervention | Experimental | In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain self-management | Behavioral | The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Diary - Average Daily Pain | App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome | Baseline,12 weeks, and 26 weeks |
| Pain Diary - Average Daily Activity Limitations | App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome | Baseline,12 weeks, and 26 weeks |
| Adaptive Coping - Coping Attempts | Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome | Baseline,12 weeks, and 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Acceptability | Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome | 2 months after starting treatment |
| Physical and Emotional Functioning - Depressive Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonya M Palermo, PhD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40839690 | Derived | Palermo TM, Srinakarin K, Zhou C, Lalloo C, Dampier C, Zempsky WT, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. Moderators of digital cognitive-behavioral therapy for youth with sickle cell disease pain: secondary analysis of a randomized controlled trial. Pain. 2025 Mar 13;166(9):e233-e243. doi: 10.1097/j.pain.0000000000003583. | |
| 37733479 | Derived | Palermo TM, Lalloo C, Zhou C, Dampier C, Zempsky W, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. A cognitive-behavioral digital health intervention for sickle cell disease pain in adolescents: a randomized, controlled, multicenter trial. Pain. 2024 Jan 1;165(1):164-176. doi: 10.1097/j.pain.0000000000003009. Epub 2023 Sep 21. |
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The number of participants refers to dyads (parents and adolescents). Enrollment and randomization assignment was by dyad. Indicated in the comments is the number of parents and adolescents.
26 participants gave consent for did not complete the pre-treatment assessment. Participants were not randomized and assigned to groups. They did not complete baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Education Control | In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks. Education: Education about sickle cell disease to increase disease knowledge |
| FG001 | Pain Self-Management Intervention | In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks. Pain self-management: The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain. Education: Education about sickle cell disease to increase disease knowledge |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Post-Treatment (12 Weeks) |
| |||||||||||||
| Follow-up (26 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Education Control | In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks. Education: Education about sickle cell disease to increase disease knowledge |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Diary - Average Daily Pain | App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | units on a scale | Baseline,12 weeks, and 26 weeks |
|
Through study completion and follow-up (average of 10 months)
Stress and anxiety at a level commensurate with participation in routine activities was not considered an Adverse Event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Education Control | In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks. Education: Education about sickle cell disease to increase disease knowledge |
Not provided
Not provided
Our trial recruitment and data collection spanned dates from before the COVID-19 pandemic to during the pandemic. This factor had an impact on our ability to reach our target enrollment into the trial as well as potential effects on outcome measurement.
Despite the strength of our high retention rate in the trial, we had a high level of missingness for some outcome data
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital | Seattle Children's Hospital | 206-884-4208 | tonya.palermo@seattlechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2021 | Jul 3, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
Not provided
Not provided
| OTHER |
| University of Florida | OTHER |
| Boston Medical Center | OTHER |
| Northwestern University | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Education | Behavioral | Education about sickle cell disease to increase disease knowledge |
|
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Depressive Symptoms T-score, higher scores means higher depressive symptoms. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of depressive symptoms.
| Baseline,12 weeks, and 26 weeks |
| Physical and Emotional Functioning - Anxiety | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Anxiety T-score, higher scores means higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of anxiety. | Baseline,12 weeks, and 26 weeks |
| Physical and Emotional Functioning - Mobility | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Mobility T-score, higher scores means better mobility. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical mobility limitations. | Baseline,12 weeks, and 26 weeks |
| Physical and Emotional Functioning - Pain Interference | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Pain Interference T-score, higher scores means more pain interference. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of pain interference. | Baseline,12 weeks, and 26 weeks |
| Physical and Emotional Functioning - Fatigue | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Fatigue T-score, higher scores means higher levels of fatigue. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of fatigue. | Baseline,12 weeks, and 26 weeks |
| Physical and Emotional Functioning - Peer Relationships | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Peer Relationships T-score, higher scores means better peer relationships. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical or reduced quality of peer relationships. | Baseline,12 weeks, and 26 weeks |
| Patient Global Impression of Change | Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome | 12 weeks and 26 weeks |
| Parent Protectiveness | Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome | Baseline,12 weeks, and 26 weeks |
| Health Services Utilization | Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits | Baseline and 26 weeks |
| Parent Psychological Distress | Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome | Baseline,12 weeks, and 26 weeks |
| Child Physical and Emotional Functioning - Parent Report, Social Functioning | Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks |
| Child Physical and Emotional Functioning - Parent Report, Physical Functioning | Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks |
| Child Physical and Emotional Functioning - Parent Report, Depression | Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks |
| Child Physical and Emotional Functioning - Parent Report, General Anxiety | Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks |
| Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks |
| Child Physical and Emotional Functioning - Parent Report, Family Functioning | Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks |
| Child Physical and Emotional Functioning - Parent Report, Development | Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks |
| Treatment Experiences - Child | Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported. | 12 weeks and 26 weeks |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| 36040789 | Derived | Lalloo C, Nishat F, Zempsky W, Bakshi N, Badawy S, Ko YJ, Dampier C, Stinson J, Palermo TM. Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Aug 30;24(8):e40096. doi: 10.2196/40096. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Pain Self-Management Intervention | In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks. Pain self-management: The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain. Education: Education about sickle cell disease to increase disease knowledge |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| SCD genotype | Clinician diagnosis of type of SCD | Count of Participants | Participants |
|
| Currently taking hydroxyurea | Count of Participants | Participants |
|
| Receiving regular blood transfusions | Count of Participants | Participants |
|
| OG001 | Pain Self-Management Intervention | In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks. Pain self-management: The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain. Education: Education about sickle cell disease to increase disease knowledge |
|
|
| Primary | Pain Diary - Average Daily Activity Limitations | App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Primary | Adaptive Coping - Coping Attempts | Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Treatment Acceptability | Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). | Posted | Mean | Standard Deviation | score on a scale | 2 months after starting treatment |
|
|
|
| Secondary | Physical and Emotional Functioning - Depressive Symptoms | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Depressive Symptoms T-score, higher scores means higher depressive symptoms. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of depressive symptoms. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | T-score | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Physical and Emotional Functioning - Anxiety | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Anxiety T-score, higher scores means higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of anxiety. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | T-score | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Physical and Emotional Functioning - Mobility | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Mobility T-score, higher scores means better mobility. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical mobility limitations. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | T-score | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Physical and Emotional Functioning - Pain Interference | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Pain Interference T-score, higher scores means more pain interference. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of pain interference. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | T-score | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Physical and Emotional Functioning - Fatigue | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Fatigue T-score, higher scores means higher levels of fatigue. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of fatigue. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | score on a scaleT-score | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Physical and Emotional Functioning - Peer Relationships | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Peer Relationships T-score, higher scores means better peer relationships. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical or reduced quality of peer relationships. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | T-score | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Patient Global Impression of Change | Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by child. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks and 26 weeks |
|
|
|
| Secondary | Parent Protectiveness | Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Health Services Utilization | Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits | At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | visits | Baseline and 26 weeks |
|
|
|
| Secondary | Parent Psychological Distress | Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Child Physical and Emotional Functioning - Parent Report, Social Functioning | Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Child Physical and Emotional Functioning - Parent Report, Physical Functioning | Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Child Physical and Emotional Functioning - Parent Report, Depression | Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Child Physical and Emotional Functioning - Parent Report, General Anxiety | Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Child Physical and Emotional Functioning - Parent Report, Family Functioning | Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Child Physical and Emotional Functioning - Parent Report, Development | Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). Remaining differences due to measure not being completed by parent. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 weeks, and 26 weeks |
|
|
|
| Secondary | Treatment Experiences - Child | Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported. | At Post-Treatment 9 subjects (4 Education Control and 5 Pain Self-Management Intervention) declined to participate or could not be reached. At Follow-up 13 subjects declined to participate or could not be reached (5 Education Control and 8 Pain Self-Management Intervention). | Posted | Count of Participants | Participants | 12 weeks and 26 weeks |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Pain Self-Management Intervention | In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks. Pain self-management: The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain. Education: Education about sickle cell disease to increase disease knowledge | 0 | 57 | 0 | 57 | 0 | 57 |
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| T2 (12 weeks) |
|
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| T3 (26 weeks) |
|
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| T2 (12 weeks) |
|
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| T3 (26 weeks) |
|
|
| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T2 (12 weeks) |
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| T3 (26 weeks) |
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| T3 (26 weeks) |
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