Trial Outcomes & Findings for iCanCope With Sickle Cell Pain (NCT NCT03201874)
NCT ID: NCT03201874
Last Updated: 2023-12-13
Results Overview
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
COMPLETED
NA
137 participants
Baseline,12 weeks, and 26 weeks
2023-12-13
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Baseline
STARTED
|
54
|
57
|
|
Baseline
COMPLETED
|
54
|
57
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Post-Treatment (12 Weeks)
STARTED
|
54
|
57
|
|
Post-Treatment (12 Weeks)
COMPLETED
|
50
|
52
|
|
Post-Treatment (12 Weeks)
NOT COMPLETED
|
4
|
5
|
|
Follow-up (26 Weeks)
STARTED
|
54
|
57
|
|
Follow-up (26 Weeks)
COMPLETED
|
49
|
49
|
|
Follow-up (26 Weeks)
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Post-Treatment (12 Weeks)
Declined due to lack of time/interest or could not be reached
|
4
|
5
|
|
Follow-up (26 Weeks)
Declined due to lack of time/interest or could not be reached
|
5
|
8
|
Baseline Characteristics
iCanCope With Sickle Cell Pain
Baseline characteristics by cohort
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.8 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
14.9 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
SCD genotype
SS
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
SCD genotype
SC
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
SCD genotype
S Beta Thal +
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
SCD genotype
S Beta Thal o
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
SCD genotype
Unknown/Missing
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Currently taking hydroxyurea
Yes
|
34 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Currently taking hydroxyurea
No
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Currently taking hydroxyurea
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Receiving regular blood transfusions
Yes
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Receiving regular blood transfusions
No
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Receiving regular blood transfusions
Missing
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
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
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Pain Diary - Average Daily Pain
T1 (baseline)
|
2.7 units on a scale
Standard Deviation 2.6
|
3.3 units on a scale
Standard Deviation 2.7
|
|
Pain Diary - Average Daily Pain
T2 (12 weeks)
|
2.6 units on a scale
Standard Deviation 2.5
|
3.3 units on a scale
Standard Deviation 2.8
|
|
Pain Diary - Average Daily Pain
T3 (26 weeks)
|
2.9 units on a scale
Standard Deviation 2.5
|
2.1 units on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
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
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Pain Diary - Average Daily Activity Limitations
T1 (baseline)
|
14.1 score on a scale
Standard Deviation 18.2
|
13.2 score on a scale
Standard Deviation 13.1
|
|
Pain Diary - Average Daily Activity Limitations
T2 (12 weeks)
|
14.8 score on a scale
Standard Deviation 16.6
|
10.6 score on a scale
Standard Deviation 12.3
|
|
Pain Diary - Average Daily Activity Limitations
T3 (26 weeks)
|
12.9 score on a scale
Standard Deviation 16.7
|
9.0 score on a scale
Standard Deviation 12.5
|
PRIMARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Adaptive Coping - Coping Attempts
T1 (baseline)
|
78.9 score on a scale
Standard Deviation 28.8
|
79.6 score on a scale
Standard Deviation 23.0
|
|
Adaptive Coping - Coping Attempts
T2 (12 weeks)
|
83.3 score on a scale
Standard Deviation 31.1
|
88.9 score on a scale
Standard Deviation 27.6
|
|
Adaptive Coping - Coping Attempts
T3 (26 weeks)
|
73.9 score on a scale
Standard Deviation 28.7
|
85.7 score on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: 2 months after starting treatmentPopulation: 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).
Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome
Outcome measures
| Measure |
Education Control
n=49 Participants
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
|
Pain Self-Management Intervention
n=44 Participants
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
|
|---|---|---|
|
Treatment Acceptability
|
34.6 score on a scale
Standard Deviation 7.7
|
34.7 score on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Physical and Emotional Functioning - Depressive Symptoms
T1 (baseline)
|
52.4 T-score
Standard Deviation 11.5
|
49.7 T-score
Standard Deviation 9.3
|
|
Physical and Emotional Functioning - Depressive Symptoms
T2 (12 weeks)
|
52.3 T-score
Standard Deviation 12.1
|
50.8 T-score
Standard Deviation 9.5
|
|
Physical and Emotional Functioning - Depressive Symptoms
T3 (26 weeks)
|
52.4 T-score
Standard Deviation 11.6
|
49.3 T-score
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Physical and Emotional Functioning - Anxiety
T1 (baseline)
|
50.1 T-score
Standard Deviation 12.2
|
50.5 T-score
Standard Deviation 11.1
|
|
Physical and Emotional Functioning - Anxiety
T2 (12 weeks)
|
50.3 T-score
Standard Deviation 11.9
|
48.6 T-score
Standard Deviation 10.8
|
|
Physical and Emotional Functioning - Anxiety
T3 (26 weeks)
|
49.9 T-score
Standard Deviation 11.4
|
46.9 T-score
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Physical and Emotional Functioning - Mobility
T1 (baseline)
|
44.2 T-score
Standard Deviation 10.3
|
42.8 T-score
Standard Deviation 10.2
|
|
Physical and Emotional Functioning - Mobility
T2 (12 weeks)
|
43.0 T-score
Standard Deviation 9.8
|
43.2 T-score
Standard Deviation 9.4
|
|
Physical and Emotional Functioning - Mobility
T3 (26 weeks)
|
44.2 T-score
Standard Deviation 9.9
|
45.4 T-score
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Physical and Emotional Functioning - Pain Interference
T1 (baseline)
|
59.9 T-score
Standard Deviation 12.7
|
60.0 T-score
Standard Deviation 10.8
|
|
Physical and Emotional Functioning - Pain Interference
T2 (12 weeks)
|
59.2 T-score
Standard Deviation 11.7
|
57.1 T-score
Standard Deviation 8.9
|
|
Physical and Emotional Functioning - Pain Interference
T3 (26 weeks)
|
58.6 T-score
Standard Deviation 12.7
|
54.7 T-score
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Physical and Emotional Functioning - Fatigue
T1 (baseline)
|
54.5 score on a scaleT-score
Standard Deviation 13.7
|
57.2 score on a scaleT-score
Standard Deviation 10.6
|
|
Physical and Emotional Functioning - Fatigue
T2 (12 weeks)
|
55.5 score on a scaleT-score
Standard Deviation 12.9
|
54.8 score on a scaleT-score
Standard Deviation 11.4
|
|
Physical and Emotional Functioning - Fatigue
T3 (26 weeks)
|
57.3 score on a scaleT-score
Standard Deviation 11.5
|
53.2 score on a scaleT-score
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Physical and Emotional Functioning - Peer Relationships
T1 (baseline)
|
44.4 T-score
Standard Deviation 10.2
|
49.2 T-score
Standard Deviation 9.0
|
|
Physical and Emotional Functioning - Peer Relationships
T2 (12 weeks)
|
43.3 T-score
Standard Deviation 11.3
|
45.4 T-score
Standard Deviation 9.1
|
|
Physical and Emotional Functioning - Peer Relationships
T3 (26 weeks)
|
43.0 T-score
Standard Deviation 11.0
|
46.6 T-score
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 12 weeks and 26 weeksPopulation: 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.
Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Patient Global Impression of Change
T2 (12 weeks)
|
3.9 score on a scale
Standard Deviation 1.8
|
4.1 score on a scale
Standard Deviation 1.5
|
|
Patient Global Impression of Change
T3 (26 weeks)
|
3.7 score on a scale
Standard Deviation 1.6
|
4.0 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Parent Protectiveness
T1 (baseline)
|
2.1 score on a scale
Standard Deviation 0.9
|
1.8 score on a scale
Standard Deviation 0.9
|
|
Parent Protectiveness
T2 (12 weeks)
|
1.9 score on a scale
Standard Deviation 0.9
|
1.5 score on a scale
Standard Deviation 0.7
|
|
Parent Protectiveness
T3 (26 weeks)
|
1.7 score on a scale
Standard Deviation 0.8
|
1.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: 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.
Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Health Services Utilization
T1 (baseline)
|
2.9 visits
Standard Deviation 3.6
|
4.0 visits
Standard Deviation 4.2
|
|
Health Services Utilization
T3 (26 weeks)
|
3.3 visits
Standard Deviation 4.3
|
2.5 visits
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Parent Psychological Distress
T1 (baseline)
|
0.59 score on a scale
Standard Deviation 0.67
|
0.41 score on a scale
Standard Deviation 0.46
|
|
Parent Psychological Distress
T2 (12 weeks)
|
0.51 score on a scale
Standard Deviation 0.50
|
0.33 score on a scale
Standard Deviation 0.39
|
|
Parent Psychological Distress
T3 (26 weeks)
|
0.55 score on a scale
Standard Deviation 0.52
|
0.42 score on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Child Physical and Emotional Functioning - Parent Report, Social Functioning
T1 (baseline)
|
12.4 score on a scale
Standard Deviation 6.4
|
12.9 score on a scale
Standard Deviation 6.1
|
|
Child Physical and Emotional Functioning - Parent Report, Social Functioning
T2 (12 weeks)
|
12.9 score on a scale
Standard Deviation 5.1
|
12.4 score on a scale
Standard Deviation 5.3
|
|
Child Physical and Emotional Functioning - Parent Report, Social Functioning
T3 (26 weeks
|
12.9 score on a scale
Standard Deviation 4.8
|
13.7 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Child Physical and Emotional Functioning - Parent Report, Physical Functioning
T1 (baseline)
|
8.4 score on a scale
Standard Deviation 4.2
|
10.3 score on a scale
Standard Deviation 6.2
|
|
Child Physical and Emotional Functioning - Parent Report, Physical Functioning
T2 (12 weeks)
|
10.2 score on a scale
Standard Deviation 4.4
|
9.7 score on a scale
Standard Deviation 4.5
|
|
Child Physical and Emotional Functioning - Parent Report, Physical Functioning
T3 (26 weeks)
|
10.3 score on a scale
Standard Deviation 5.7
|
9.7 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Child Physical and Emotional Functioning - Parent Report, Depression
T1 (baseline)
|
7.4 score on a scale
Standard Deviation 4.9
|
6.8 score on a scale
Standard Deviation 4.2
|
|
Child Physical and Emotional Functioning - Parent Report, Depression
T2 (12 weeks)
|
7.6 score on a scale
Standard Deviation 4.3
|
6.5 score on a scale
Standard Deviation 3.6
|
|
Child Physical and Emotional Functioning - Parent Report, Depression
T3 (26 weeks)
|
7.3 score on a scale
Standard Deviation 4.5
|
7.7 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Child Physical and Emotional Functioning - Parent Report, General Anxiety
T1 (baseline)
|
6.7 score on a scale
Standard Deviation 5.0
|
7.4 score on a scale
Standard Deviation 5.3
|
|
Child Physical and Emotional Functioning - Parent Report, General Anxiety
T2 (12 weeks)
|
7.8 score on a scale
Standard Deviation 4.5
|
7.0 score on a scale
Standard Deviation 4.9
|
|
Child Physical and Emotional Functioning - Parent Report, General Anxiety
T3 (26 weeks)
|
7.4 score on a scale
Standard Deviation 5.1
|
8.8 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety
T1 (baseline)
|
12.7 score on a scale
Standard Deviation 6.3
|
12.2 score on a scale
Standard Deviation 6.6
|
|
Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety
T2 (12 weeks)
|
12.9 score on a scale
Standard Deviation 6.6
|
11.1 score on a scale
Standard Deviation 5.6
|
|
Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety
T3 (26 weeks)
|
11.5 score on a scale
Standard Deviation 6.5
|
10.8 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Child Physical and Emotional Functioning - Parent Report, Family Functioning
T1 (baseline)
|
13.5 score on a scale
Standard Deviation 8.0
|
13.4 score on a scale
Standard Deviation 7.1
|
|
Child Physical and Emotional Functioning - Parent Report, Family Functioning
T2 (12 weeks)
|
13.5 score on a scale
Standard Deviation 6.4
|
12.9 score on a scale
Standard Deviation 6.5
|
|
Child Physical and Emotional Functioning - Parent Report, Family Functioning
T3 (26 weeks)
|
13.2 score on a scale
Standard Deviation 7.1
|
12.9 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline,12 weeks, and 26 weeksPopulation: 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.
Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Child Physical and Emotional Functioning - Parent Report, Development
T1 (baseline)
|
15.0 score on a scale
Standard Deviation 8.0
|
15.7 score on a scale
Standard Deviation 7.6
|
|
Child Physical and Emotional Functioning - Parent Report, Development
T2 (12 weeks)
|
15.3 score on a scale
Standard Deviation 7.9
|
14.5 score on a scale
Standard Deviation 8.6
|
|
Child Physical and Emotional Functioning - Parent Report, Development
T3 (26 weeks)
|
15.5 score on a scale
Standard Deviation 7.5
|
14.7 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 12 weeks and 26 weeksPopulation: 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).
Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported.
Outcome measures
| Measure |
Education Control
n=54 Participants
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
|
Pain Self-Management Intervention
n=57 Participants
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
|
|---|---|---|
|
Treatment Experiences - Child
T3 (26 weeks)
|
2 Participants
|
0 Participants
|
|
Treatment Experiences - Child
T2 (12 weeks)
|
1 Participants
|
0 Participants
|
Adverse Events
Education Control
Pain Self-Management Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
Seattle Children's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place