Sickle Cell Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPain 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.
BEHAVIORALEducation
Education about sickle cell disease to increase disease knowledge
Sponsors
The Hospital for Sick Children
Emory University
Connecticut Children's Medical Center
University of Mississippi Medical Center
University of Florida
Boston Medical Center
Northwestern University
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* aged between 12-18 years * diagnosed with any type of SCD * able to speak and read English * score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview * willing and able to complete online measures
Exclusion criteria
* significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent * have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Diary - Average Daily Pain | Baseline,12 weeks, and 26 weeks | 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 |
| Pain Diary - Average Daily Activity Limitations | Baseline,12 weeks, and 26 weeks | 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 |
| Adaptive Coping - Coping Attempts | Baseline,12 weeks, and 26 weeks | Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical and Emotional Functioning - Mobility | Baseline,12 weeks, and 26 weeks | 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. |
| Physical and Emotional Functioning - Pain Interference | Baseline,12 weeks, and 26 weeks | 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. |
| Physical and Emotional Functioning - Fatigue | Baseline,12 weeks, and 26 weeks | 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. |
| Physical and Emotional Functioning - Peer Relationships | Baseline,12 weeks, and 26 weeks | 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. |
| Patient Global Impression of Change | 12 weeks and 26 weeks | Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome |
| Parent Protectiveness | Baseline,12 weeks, and 26 weeks | Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome |
| Health Services Utilization | Baseline and 26 weeks | Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits |
| Parent Psychological Distress | Baseline,12 weeks, and 26 weeks | Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome |
| Treatment Acceptability | 2 months after starting treatment | Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome |
| Child Physical and Emotional Functioning - Parent Report, Physical Functioning | Baseline,12 weeks, and 26 weeks | Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales. |
| Child Physical and Emotional Functioning - Parent Report, Depression | Baseline,12 weeks, and 26 weeks | Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales. |
| Child Physical and Emotional Functioning - Parent Report, General Anxiety | Baseline,12 weeks, and 26 weeks | Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales. |
| Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | Baseline,12 weeks, and 26 weeks | Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales. |
| Child Physical and Emotional Functioning - Parent Report, Family Functioning | Baseline,12 weeks, and 26 weeks | Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales. |
| Child Physical and Emotional Functioning - Parent Report, Development | Baseline,12 weeks, and 26 weeks | Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales. |
| Treatment Experiences - Child | 12 weeks and 26 weeks | Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported. |
| Child Physical and Emotional Functioning - Parent Report, Social Functioning | Baseline,12 weeks, and 26 weeks | Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales. |
| Physical and Emotional Functioning - Depressive Symptoms | Baseline,12 weeks, and 26 weeks | 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. |
| Physical and Emotional Functioning - Anxiety | Baseline,12 weeks, and 26 weeks | 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 54 |
| 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 | 57 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up (26 Weeks) | Declined due to lack of time/interest or could not be reached | 5 | 8 |
| Post-Treatment (12 Weeks) | Declined due to lack of time/interest or could not be reached | 4 | 5 |
Baseline characteristics
| Characteristic | Education Control | Pain Self-Management Intervention | Total |
|---|---|---|---|
| Age, Continuous | 14.8 years STANDARD_DEVIATION 1.9 | 14.9 years STANDARD_DEVIATION 2 | 14.8 years STANDARD_DEVIATION 1.9 |
| Currently taking hydroxyurea Missing | 2 Participants | 1 Participants | 3 Participants |
| Currently taking hydroxyurea No | 18 Participants | 15 Participants | 33 Participants |
| Currently taking hydroxyurea Yes | 34 Participants | 41 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 47 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 51 Participants | 98 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Receiving regular blood transfusions Missing | 2 Participants | 2 Participants | 4 Participants |
| Receiving regular blood transfusions No | 47 Participants | 47 Participants | 94 Participants |
| Receiving regular blood transfusions Yes | 5 Participants | 8 Participants | 13 Participants |
| Region of Enrollment Canada | 16 Participants | 11 Participants | 27 Participants |
| Region of Enrollment United States | 38 Participants | 46 Participants | 84 Participants |
| SCD genotype S Beta Thal + | 3 Participants | 3 Participants | 6 Participants |
| SCD genotype S Beta Thal o | 2 Participants | 3 Participants | 5 Participants |
| SCD genotype SC | 14 Participants | 12 Participants | 26 Participants |
| SCD genotype SS | 33 Participants | 36 Participants | 69 Participants |
| SCD genotype Unknown/Missing | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 31 Participants | 34 Participants | 65 Participants |
| Sex: Female, Male Male | 23 Participants | 23 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 57 |
| other Total, other adverse events | 0 / 54 | 0 / 57 |
| serious Total, serious adverse events | 0 / 54 | 0 / 57 |
Outcome results
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
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Adaptive Coping - Coping Attempts | T1 (baseline) | 78.9 score on a scale | Standard Deviation 28.8 |
| Education Control | Adaptive Coping - Coping Attempts | T2 (12 weeks) | 83.3 score on a scale | Standard Deviation 31.1 |
| Education Control | Adaptive Coping - Coping Attempts | T3 (26 weeks) | 73.9 score on a scale | Standard Deviation 28.7 |
| Pain Self-Management Intervention | Adaptive Coping - Coping Attempts | T1 (baseline) | 79.6 score on a scale | Standard Deviation 23 |
| Pain Self-Management Intervention | Adaptive Coping - Coping Attempts | T2 (12 weeks) | 88.9 score on a scale | Standard Deviation 27.6 |
| Pain Self-Management Intervention | Adaptive Coping - Coping Attempts | T3 (26 weeks) | 85.7 score on a scale | Standard Deviation 24 |
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
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Pain Diary - Average Daily Activity Limitations | T1 (baseline) | 14.1 score on a scale | Standard Deviation 18.2 |
| Education Control | Pain Diary - Average Daily Activity Limitations | T2 (12 weeks) | 14.8 score on a scale | Standard Deviation 16.6 |
| Education Control | Pain Diary - Average Daily Activity Limitations | T3 (26 weeks) | 12.9 score on a scale | Standard Deviation 16.7 |
| Pain Self-Management Intervention | Pain Diary - Average Daily Activity Limitations | T1 (baseline) | 13.2 score on a scale | Standard Deviation 13.1 |
| Pain Self-Management Intervention | Pain Diary - Average Daily Activity Limitations | T2 (12 weeks) | 10.6 score on a scale | Standard Deviation 12.3 |
| Pain Self-Management Intervention | Pain Diary - Average Daily Activity Limitations | T3 (26 weeks) | 9.0 score on a scale | Standard Deviation 12.5 |
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
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Pain Diary - Average Daily Pain | T1 (baseline) | 2.7 units on a scale | Standard Deviation 2.6 |
| Education Control | Pain Diary - Average Daily Pain | T2 (12 weeks) | 2.6 units on a scale | Standard Deviation 2.5 |
| Education Control | Pain Diary - Average Daily Pain | T3 (26 weeks) | 2.9 units on a scale | Standard Deviation 2.5 |
| Pain Self-Management Intervention | Pain Diary - Average Daily Pain | T1 (baseline) | 3.3 units on a scale | Standard Deviation 2.7 |
| Pain Self-Management Intervention | Pain Diary - Average Daily Pain | T2 (12 weeks) | 3.3 units on a scale | Standard Deviation 2.8 |
| Pain Self-Management Intervention | Pain Diary - Average Daily Pain | T3 (26 weeks) | 2.1 units on a scale | Standard Deviation 2.3 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Child Physical and Emotional Functioning - Parent Report, Depression | T1 (baseline) | 7.4 score on a scale | Standard Deviation 4.9 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Depression | T2 (12 weeks) | 7.6 score on a scale | Standard Deviation 4.3 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Depression | T3 (26 weeks) | 7.3 score on a scale | Standard Deviation 4.5 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Depression | T1 (baseline) | 6.8 score on a scale | Standard Deviation 4.2 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Depression | T2 (12 weeks) | 6.5 score on a scale | Standard Deviation 3.6 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Depression | T3 (26 weeks) | 7.7 score on a scale | Standard Deviation 4.2 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Child Physical and Emotional Functioning - Parent Report, Development | T1 (baseline) | 15.0 score on a scale | Standard Deviation 8 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Development | T2 (12 weeks) | 15.3 score on a scale | Standard Deviation 7.9 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Development | T3 (26 weeks) | 15.5 score on a scale | Standard Deviation 7.5 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Development | T1 (baseline) | 15.7 score on a scale | Standard Deviation 7.6 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Development | T2 (12 weeks) | 14.5 score on a scale | Standard Deviation 8.6 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Development | T3 (26 weeks) | 14.7 score on a scale | Standard Deviation 9.4 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Child Physical and Emotional Functioning - Parent Report, Family Functioning | T1 (baseline) | 13.5 score on a scale | Standard Deviation 8 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Family Functioning | T2 (12 weeks) | 13.5 score on a scale | Standard Deviation 6.4 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Family Functioning | T3 (26 weeks) | 13.2 score on a scale | Standard Deviation 7.1 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Family Functioning | T1 (baseline) | 13.4 score on a scale | Standard Deviation 7.1 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Family Functioning | T2 (12 weeks) | 12.9 score on a scale | Standard Deviation 6.5 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Family Functioning | T3 (26 weeks) | 12.9 score on a scale | Standard Deviation 7.7 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Child Physical and Emotional Functioning - Parent Report, General Anxiety | T1 (baseline) | 6.7 score on a scale | Standard Deviation 5 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, General Anxiety | T2 (12 weeks) | 7.8 score on a scale | Standard Deviation 4.5 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, General Anxiety | T3 (26 weeks) | 7.4 score on a scale | Standard Deviation 5.1 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, General Anxiety | T1 (baseline) | 7.4 score on a scale | Standard Deviation 5.3 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, General Anxiety | T2 (12 weeks) | 7.0 score on a scale | Standard Deviation 4.9 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, General Anxiety | T3 (26 weeks) | 8.8 score on a scale | Standard Deviation 5.3 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | T1 (baseline) | 12.7 score on a scale | Standard Deviation 6.3 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | T2 (12 weeks) | 12.9 score on a scale | Standard Deviation 6.6 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | T3 (26 weeks) | 11.5 score on a scale | Standard Deviation 6.5 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | T1 (baseline) | 12.2 score on a scale | Standard Deviation 6.6 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | T2 (12 weeks) | 11.1 score on a scale | Standard Deviation 5.6 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | T3 (26 weeks) | 10.8 score on a scale | Standard Deviation 5.4 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Child Physical and Emotional Functioning - Parent Report, Physical Functioning | T1 (baseline) | 8.4 score on a scale | Standard Deviation 4.2 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Physical Functioning | T2 (12 weeks) | 10.2 score on a scale | Standard Deviation 4.4 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Physical Functioning | T3 (26 weeks) | 10.3 score on a scale | Standard Deviation 5.7 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Physical Functioning | T1 (baseline) | 10.3 score on a scale | Standard Deviation 6.2 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Physical Functioning | T2 (12 weeks) | 9.7 score on a scale | Standard Deviation 4.5 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Physical Functioning | T3 (26 weeks) | 9.7 score on a scale | Standard Deviation 4.8 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Child Physical and Emotional Functioning - Parent Report, Social Functioning | T1 (baseline) | 12.4 score on a scale | Standard Deviation 6.4 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Social Functioning | T2 (12 weeks) | 12.9 score on a scale | Standard Deviation 5.1 |
| Education Control | Child Physical and Emotional Functioning - Parent Report, Social Functioning | T3 (26 weeks | 12.9 score on a scale | Standard Deviation 4.8 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Social Functioning | T1 (baseline) | 12.9 score on a scale | Standard Deviation 6.1 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Social Functioning | T2 (12 weeks) | 12.4 score on a scale | Standard Deviation 5.3 |
| Pain Self-Management Intervention | Child Physical and Emotional Functioning - Parent Report, Social Functioning | T3 (26 weeks | 13.7 score on a scale | Standard Deviation 5.7 |
Secondary
Health Services Utilization
Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits
Time frame: Baseline and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Health Services Utilization | T1 (baseline) | 2.9 visits | Standard Deviation 3.6 |
| Education Control | Health Services Utilization | T3 (26 weeks) | 3.3 visits | Standard Deviation 4.3 |
| Pain Self-Management Intervention | Health Services Utilization | T1 (baseline) | 4.0 visits | Standard Deviation 4.2 |
| Pain Self-Management Intervention | Health Services Utilization | T3 (26 weeks) | 2.5 visits | Standard Deviation 3.3 |
Secondary
Parent Protectiveness
Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Parent Protectiveness | T1 (baseline) | 2.1 score on a scale | Standard Deviation 0.9 |
| Education Control | Parent Protectiveness | T2 (12 weeks) | 1.9 score on a scale | Standard Deviation 0.9 |
| Education Control | Parent Protectiveness | T3 (26 weeks) | 1.7 score on a scale | Standard Deviation 0.8 |
| Pain Self-Management Intervention | Parent Protectiveness | T1 (baseline) | 1.8 score on a scale | Standard Deviation 0.9 |
| Pain Self-Management Intervention | Parent Protectiveness | T2 (12 weeks) | 1.5 score on a scale | Standard Deviation 0.7 |
| Pain Self-Management Intervention | Parent Protectiveness | T3 (26 weeks) | 1.5 score on a scale | Standard Deviation 0.9 |
Secondary
Parent Psychological Distress
Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Parent Psychological Distress | T1 (baseline) | 0.59 score on a scale | Standard Deviation 0.67 |
| Education Control | Parent Psychological Distress | T2 (12 weeks) | 0.51 score on a scale | Standard Deviation 0.5 |
| Education Control | Parent Psychological Distress | T3 (26 weeks) | 0.55 score on a scale | Standard Deviation 0.52 |
| Pain Self-Management Intervention | Parent Psychological Distress | T2 (12 weeks) | 0.33 score on a scale | Standard Deviation 0.39 |
| Pain Self-Management Intervention | Parent Psychological Distress | T1 (baseline) | 0.41 score on a scale | Standard Deviation 0.46 |
| Pain Self-Management Intervention | Parent Psychological Distress | T3 (26 weeks) | 0.42 score on a scale | Standard Deviation 0.5 |
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
Time frame: 12 weeks and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Patient Global Impression of Change | T2 (12 weeks) | 3.9 score on a scale | Standard Deviation 1.8 |
| Education Control | Patient Global Impression of Change | T3 (26 weeks) | 3.7 score on a scale | Standard Deviation 1.6 |
| Pain Self-Management Intervention | Patient Global Impression of Change | T2 (12 weeks) | 4.1 score on a scale | Standard Deviation 1.5 |
| Pain Self-Management Intervention | Patient Global Impression of Change | T3 (26 weeks) | 4.0 score on a scale | Standard Deviation 1.8 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Physical and Emotional Functioning - Anxiety | T1 (baseline) | 50.1 T-score | Standard Deviation 12.2 |
| Education Control | Physical and Emotional Functioning - Anxiety | T2 (12 weeks) | 50.3 T-score | Standard Deviation 11.9 |
| Education Control | Physical and Emotional Functioning - Anxiety | T3 (26 weeks) | 49.9 T-score | Standard Deviation 11.4 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Anxiety | T1 (baseline) | 50.5 T-score | Standard Deviation 11.1 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Anxiety | T2 (12 weeks) | 48.6 T-score | Standard Deviation 10.8 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Anxiety | T3 (26 weeks) | 46.9 T-score | Standard Deviation 11.6 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Physical and Emotional Functioning - Depressive Symptoms | T1 (baseline) | 52.4 T-score | Standard Deviation 11.5 |
| Education Control | Physical and Emotional Functioning - Depressive Symptoms | T2 (12 weeks) | 52.3 T-score | Standard Deviation 12.1 |
| Education Control | Physical and Emotional Functioning - Depressive Symptoms | T3 (26 weeks) | 52.4 T-score | Standard Deviation 11.6 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Depressive Symptoms | T1 (baseline) | 49.7 T-score | Standard Deviation 9.3 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Depressive Symptoms | T2 (12 weeks) | 50.8 T-score | Standard Deviation 9.5 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Depressive Symptoms | T3 (26 weeks) | 49.3 T-score | Standard Deviation 9.3 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Physical and Emotional Functioning - Fatigue | T1 (baseline) | 54.5 score on a scaleT-score | Standard Deviation 13.7 |
| Education Control | Physical and Emotional Functioning - Fatigue | T2 (12 weeks) | 55.5 score on a scaleT-score | Standard Deviation 12.9 |
| Education Control | Physical and Emotional Functioning - Fatigue | T3 (26 weeks) | 57.3 score on a scaleT-score | Standard Deviation 11.5 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Fatigue | T1 (baseline) | 57.2 score on a scaleT-score | Standard Deviation 10.6 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Fatigue | T2 (12 weeks) | 54.8 score on a scaleT-score | Standard Deviation 11.4 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Fatigue | T3 (26 weeks) | 53.2 score on a scaleT-score | Standard Deviation 12.6 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Physical and Emotional Functioning - Mobility | T2 (12 weeks) | 43.0 T-score | Standard Deviation 9.8 |
| Education Control | Physical and Emotional Functioning - Mobility | T1 (baseline) | 44.2 T-score | Standard Deviation 10.3 |
| Education Control | Physical and Emotional Functioning - Mobility | T3 (26 weeks) | 44.2 T-score | Standard Deviation 9.9 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Mobility | T1 (baseline) | 42.8 T-score | Standard Deviation 10.2 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Mobility | T2 (12 weeks) | 43.2 T-score | Standard Deviation 9.4 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Mobility | T3 (26 weeks) | 45.4 T-score | Standard Deviation 8.9 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Physical and Emotional Functioning - Pain Interference | T1 (baseline) | 59.9 T-score | Standard Deviation 12.7 |
| Education Control | Physical and Emotional Functioning - Pain Interference | T2 (12 weeks) | 59.2 T-score | Standard Deviation 11.7 |
| Education Control | Physical and Emotional Functioning - Pain Interference | T3 (26 weeks) | 58.6 T-score | Standard Deviation 12.7 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Pain Interference | T1 (baseline) | 60.0 T-score | Standard Deviation 10.8 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Pain Interference | T2 (12 weeks) | 57.1 T-score | Standard Deviation 8.9 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Pain Interference | T3 (26 weeks) | 54.7 T-score | Standard Deviation 11.2 |
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.
Time frame: Baseline,12 weeks, and 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Control | Physical and Emotional Functioning - Peer Relationships | T1 (baseline) | 44.4 T-score | Standard Deviation 10.2 |
| Education Control | Physical and Emotional Functioning - Peer Relationships | T2 (12 weeks) | 43.3 T-score | Standard Deviation 11.3 |
| Education Control | Physical and Emotional Functioning - Peer Relationships | T3 (26 weeks) | 43.0 T-score | Standard Deviation 11 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Peer Relationships | T1 (baseline) | 49.2 T-score | Standard Deviation 9 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Peer Relationships | T2 (12 weeks) | 45.4 T-score | Standard Deviation 9.1 |
| Pain Self-Management Intervention | Physical and Emotional Functioning - Peer Relationships | T3 (26 weeks) | 46.6 T-score | Standard Deviation 10.4 |
Secondary
Treatment Acceptability
Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome
Time frame: 2 months after starting treatment
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Control | Treatment Acceptability | 34.6 score on a scale | Standard Deviation 7.7 |
| Pain Self-Management Intervention | Treatment Acceptability | 34.7 score on a scale | Standard Deviation 5.5 |
Secondary
Treatment Experiences - Child
Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported.
Time frame: 12 weeks and 26 weeks
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Education Control | Treatment Experiences - Child | T2 (12 weeks) | 1 Participants |
| Education Control | Treatment Experiences - Child | T3 (26 weeks) | 2 Participants |
| Pain Self-Management Intervention | Treatment Experiences - Child | T2 (12 weeks) | 0 Participants |
| Pain Self-Management Intervention | Treatment Experiences - Child | T3 (26 weeks) | 0 Participants |