Trial Outcomes & Findings for Development and Adaptation of I-STRONG for SCD (NCT NCT06110754)
NCT ID: NCT06110754
Last Updated: 2025-12-19
Results Overview
Pain intensity is rated with the pain severity item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)
Results posted on
2025-12-19
Participant Flow
Participants were recruited from Children's Healthcare of Atlanta in Atlanta, Georgia, and Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio, USA. Participants for Aim 1 were enrolled June through October 2023. Participant enrollment for Aim 2 began October 24, 2023 and all follow-up assessments were completed by June 14, 2024.
Participant milestones
| Measure |
Development of I-STRONG for Sickle Cell Disease (SCD) - Adolescents (Aim 1)
Adolescents with sickle cell disease completing in-depth interviews over two sessions as part of adapting an integrative, multicomponent, behavioral intervention combining mind-body, cognitive, and behavioral coping skills with neuromuscular exercise training for adolescents with chronic SCD pain. Outcome measures are not collected from participants in Aim 1 as the purpose of this part of the study is to prepare the I-STRONG intervention to be studied for Aim 2.
|
Development of I-STRONG for SCD - Parents (Aim 1)
Parents of adolescents with sickle cell disease completing in-depth interviews over two sessions as part of adapting an integrative, multicomponent, behavioral intervention combining mind-body, cognitive, and behavioral coping skills with neuromuscular exercise training for adolescents with chronic SCD pain. Outcome measures are not collected from participants in Aim 1 as the purpose of this part of the study is to prepare the I-STRONG intervention to be studied for Aim 2.
|
I-STRONG for Adolescents With SCD (Aim 2)
Adolescents with sickle cell disease (SCD) participating in a multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training.
Integrative Strong Body and Mind Training (I-STRONG) for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD (Aim 2)
Parents of adolescents with sickle cell disease participating in a multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. Parents are enrolled when the adolescent is under the age of 18.
I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
9
|
|
Overall Study
COMPLETED
|
12
|
12
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Development of I-STRONG for Sickle Cell Disease (SCD) - Adolescents (Aim 1)
Adolescents with sickle cell disease completing in-depth interviews over two sessions as part of adapting an integrative, multicomponent, behavioral intervention combining mind-body, cognitive, and behavioral coping skills with neuromuscular exercise training for adolescents with chronic SCD pain. Outcome measures are not collected from participants in Aim 1 as the purpose of this part of the study is to prepare the I-STRONG intervention to be studied for Aim 2.
|
Development of I-STRONG for SCD - Parents (Aim 1)
Parents of adolescents with sickle cell disease completing in-depth interviews over two sessions as part of adapting an integrative, multicomponent, behavioral intervention combining mind-body, cognitive, and behavioral coping skills with neuromuscular exercise training for adolescents with chronic SCD pain. Outcome measures are not collected from participants in Aim 1 as the purpose of this part of the study is to prepare the I-STRONG intervention to be studied for Aim 2.
|
I-STRONG for Adolescents With SCD (Aim 2)
Adolescents with sickle cell disease (SCD) participating in a multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training.
Integrative Strong Body and Mind Training (I-STRONG) for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD (Aim 2)
Parents of adolescents with sickle cell disease participating in a multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. Parents are enrolled when the adolescent is under the age of 18.
I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
Baseline characteristics by cohort
| Measure |
Development of I-STRONG for SCD - Adolescents (Aim 1)
n=12 Participants
Adolescents with sickle cell disease completing in-depth interviews over two sessions as part of adapting an integrative, multicomponent, behavioral intervention combining mind-body, cognitive, and behavioral coping skills with neuromuscular exercise training for adolescents with chronic SCD pain.
|
Development of I-STRONG for SCD - Adults (Aim 1)
n=12 Participants
Parents of adolescents with sickle cell disease completing in-depth interviews over two sessions as part of adapting an integrative, multicomponent, behavioral intervention combining mind-body, cognitive, and behavioral coping skills with neuromuscular exercise training for adolescents with chronic SCD pain.
|
I-STRONG for Adolescents With SCD (Aim 2)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD (Aim 2)
n=9 Participants
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
21 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
9 Participants
n=9 Participants
|
24 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=45 Participants
|
|
Age, Continuous
|
16.03 years
STANDARD_DEVIATION 1.58 • n=12 Participants
|
39.50 years
STANDARD_DEVIATION 5.63 • n=12 Participants
|
16.30 years
STANDARD_DEVIATION 1.61 • n=12 Participants
|
40.80 years
STANDARD_DEVIATION 4.40 • n=9 Participants
|
26.27 years
STANDARD_DEVIATION 12.36 • n=45 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
9 Participants
n=9 Participants
|
32 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
13 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=12 Participants
|
11 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
8 Participants
n=9 Participants
|
43 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
8 Participants
n=9 Participants
|
44 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=45 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
9 Participants
n=9 Participants
|
45 Participants
n=45 Participants
|
|
Sickle Cell Disease Genotype
HbSS (Aim 2)
|
0 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
8 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
8 Participants
n=24 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
|
Sickle Cell Disease Genotype
HbSC (Aim 2)
|
0 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
2 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
2 Participants
n=24 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
|
Sickle Cell Disease Genotype
HbSβ+ thalassemia (Aim 2)
|
0 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
1 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
1 Participants
n=24 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
|
Sickle Cell Disease Genotype
HbSβ0 thalassemia (Aim 2)
|
0 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
1 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
1 Participants
n=24 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
|
Sickle Cell Disease Genotype
HbSS or HbSβ0 thalassemia (Aim 1 categorization)
|
11 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
0 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
11 Participants
n=24 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
|
Sickle Cell Disease Genotype
HbSC or HbSβ+ thalassemia (Aim 1 categorization)
|
1 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
0 Participants
n=12 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
—
|
1 Participants
n=24 Participants • Sickle cell disease genotype is only relevant for adolescent participants with sickle cell disease. Genotypes HbSS and HbSβ0 thalassemia are generally the most severe forms of SCD.
|
PRIMARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent participants who completed the indicated study visit and completed the survey. One participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5.
Pain intensity is rated with the pain severity item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Brief Pain Inventory (BPI) Pain Severity Score
Baseline
|
5.75 units on a scale
Standard Deviation 2.63
|
—
|
|
Brief Pain Inventory (BPI) Pain Severity Score
Post-treatment (Week 8)
|
4.36 units on a scale
Standard Deviation 1.96
|
—
|
|
Brief Pain Inventory (BPI) Pain Severity Score
3 Months Post-treatment (Month 5)
|
3.89 units on a scale
Standard Deviation 2.15
|
—
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent participants who completed the indicated study visit and completed the survey. One participant withdrew prior to the post-treatment assessment at Week 8, an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5, and one participant did not complete this survey during the 3 months post-treatment assessment.
Functional interference due to pain rated with the impact of pain on daily functions item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Brief Pain Inventory (BPI) Pain Interference Score
Baseline
|
3.45 units on a scale
Standard Deviation 3.09
|
—
|
|
Brief Pain Inventory (BPI) Pain Interference Score
Post-treatment (Week 8)
|
4.24 units on a scale
Standard Deviation 2.62
|
—
|
|
Brief Pain Inventory (BPI) Pain Interference Score
3 Months Post-treatment (Month 5)
|
2.94 units on a scale
Standard Deviation 2.15
|
—
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent and adult participants who completed the indicated study visit and completed the survey. One adolescent participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5.
Depressive symptoms in past two weeks among adolescent and parent study participants is assessed with the Patient Health Questionnaire (PHQ-8). The PHQ-8 has 8 items that are responded to on a 4-point scale where " not at all" = 0 and "nearly every day" = 3. Total scores range from 0 to 24 where higher scores indicate increased symptoms of depression.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
n=9 Participants
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-8) Score
Baseline
|
6.50 score on a scale
Standard Deviation 5.69
|
5.33 score on a scale
Standard Deviation 4.8
|
|
Patient Health Questionnaire (PHQ-8) Score
Post-treatment (Week 8)
|
6.82 score on a scale
Standard Deviation 6.52
|
5.11 score on a scale
Standard Deviation 7.8
|
|
Patient Health Questionnaire (PHQ-8) Score
3 Months Post-treatment (Month 5)
|
5.40 score on a scale
Standard Deviation 3.41
|
5.22 score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent and adult participants who completed the indicated study visit and completed the survey. One adolescent participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5.
General worry in past two weeks among adolescent and parent study participants is assessed with the General Anxiety Disorder (GAD-2) instrument. The GAD-2 has 2 items that are responded to on a 4-point scale where " not at all" = 0 and "nearly every day" = 3. Total scores range from 0 to 6 where higher scores indicate increased experiences of worry.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
n=9 Participants
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
General Anxiety Disorder (GAD-2) Score
Post-treatment (Week 8)
|
1.45 score on a scale
Standard Deviation 1.44
|
1.11 score on a scale
Standard Deviation 1.9
|
|
General Anxiety Disorder (GAD-2) Score
Baseline
|
2.08 score on a scale
Standard Deviation 1.72
|
2.11 score on a scale
Standard Deviation 2.2
|
|
General Anxiety Disorder (GAD-2) Score
3 Months Post-treatment (Month 5)
|
1.20 score on a scale
Standard Deviation 1.32
|
1.11 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-Treatment (Month 5)Population: The analysis population includes adolescent and adult participants who completed the indicated study visit and completed the survey. One adolescent participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5.
Exaggerated worried thoughts of pain are assessed among adolescent and parent study participants. The Pain Catastrophizing Scale, Child and Parent Report, is a 13-item well-validated self-report and parent-report measure of worried thoughts about pain. Items are answered on a 5-point scale where 0 = not true at all and 4 = very true. Total scores range from 0 to 52 and higher scores indicate increased catastrophic thinking.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
n=9 Participants
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Pain Catastrophizing Scale Score
Baseline
|
24.33 score on a scale
Standard Deviation 13.05
|
28.33 score on a scale
Standard Deviation 10.2
|
|
Pain Catastrophizing Scale Score
Post-treatment (Week 8)
|
22.82 score on a scale
Standard Deviation 14.06
|
30.56 score on a scale
Standard Deviation 9.9
|
|
Pain Catastrophizing Scale Score
3 Months Post-treatment (Month 5)
|
21.00 score on a scale
Standard Deviation 12.33
|
26.33 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent participants who completed the indicated study visit and completed the survey. One participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5. This survey was not administered to parents.
Health-related quality of life and impact on child and family in the past month is assessed among adolescent study participants with the Pediatric Quality of Life Inventory (PedsQL). The 23-item PedsQL was developed as part of the NIH Roadmap Initiative to create universal measures for patient-reported outcomes and contains questions in the domains of social-peer, depression, anxiety, mobility, and function. Responses are given on a 5-point scale where 0 = never and 4 = almost always. Items are reverse scored and linearly transformed to a scale of 0 to 100, where higher total mean scores indicate a better quality of life.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL) Score
Baseline
|
69.03 score on a scale
Standard Deviation 15.03
|
—
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
Post-treatment (Week 8)
|
64.85 score on a scale
Standard Deviation 17.25
|
—
|
|
Pediatric Quality of Life Inventory (PedsQL) Score
3 Months Post-treatment (Month 5)
|
73.83 score on a scale
Standard Deviation 16.56
|
—
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent participants who completed the indicated study visit and completed the survey. One participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5.
The Adolescent Sleep Wake Scale (ASWS) is a 28-item patient-reported describing the occurrence and frequency of various behavioral sleep characteristics over the past month. Responses are given on a 6-point Likert scale where 1 = always and 6 = never. Total scores range from 28 to 168 and higher scores indicate better sleep quality.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Adolescent Sleep-Wake Scale (ASWS) Score
Baseline
|
38.00 score on a scale
Standard Deviation 9.73
|
—
|
|
Adolescent Sleep-Wake Scale (ASWS) Score
Post-treatment (Week 8)
|
37.55 score on a scale
Standard Deviation 9.98
|
—
|
|
Adolescent Sleep-Wake Scale (ASWS) Score
3 Months Post-treatment (Month 5)
|
41.00 score on a scale
Standard Deviation 6.58
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent participants who completed the indicated study visit and completed the survey. One participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5.
Substance use among adolescent study participants during the past 3 months is assessed with the NIDA-Modified Assist Tool Level 2 for children aged 11-17. The instrument asks respondents how often they have used 15 different substances. Responses are given on a 5-point scale where "not at all" = 0, "less than a day or two" = 1, "several days" = 2, "more than half the days" = 3, and "nearly every day" = 4. Responses to items were then scored as either 0 for non-use of a particular substance or 1 for any use of a particular substance (encompassing scale scores of 1 - 4). The tool is scored as the number of items with a score of greater than 0. The total score ranges from 0 to 15 with higher values indicating use of a greater number of substances.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2
Baseline
|
0.58 score on a scale
Standard Deviation 0.90
|
—
|
|
National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2
3 Months Post-treatment (Month 5)
|
0.50 score on a scale
Standard Deviation 0.71
|
—
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes participants who completed any number of days of the daily diaries for the indicated time point. Some participants did not complete any diary days.
Daily use of opioid pain medication is determined based on participant completion of daily diaries for one week at each assessment visit. Participants record opioid use daily as presence or absence of use.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=10 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Days of Opioid Use Per Week
Baseline
|
1.00 days per week of opioid use
Standard Deviation 2.12
|
—
|
|
Days of Opioid Use Per Week
Post-treatment (Week 8)
|
1.70 days per week of opioid use
Standard Deviation 2.49
|
—
|
|
Days of Opioid Use Per Week
3 Months Post-treatment (Month 5)
|
2.25 days per week of opioid use
Standard Deviation 2.25
|
—
|
SECONDARY outcome
Timeframe: Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent participants who completed the indicated study visit and completed the survey. One participant withdrew prior to the post-treatment assessment at Week 8 and two additional participants declined to complete this survey at the 3 months post-treatment assessment at Month 5.
The overall self-reported rating of the efficacy of treatment is assessed with the Patient Global Impression of Change (PGIC) instrument. The PGIC asks respondents to rate their overall improvement compared to baseline. Responses are given on a scale of 1 to 7 where 1 = very much improved and 7 = very much worse.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=11 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Change in Patient Global Impression of Change (PGIC) Score
Baseline to Post-treatment (Week 8)
|
1.36 units on a scale
Standard Deviation 1.03
|
—
|
|
Change in Patient Global Impression of Change (PGIC) Score
Baseline to 3 Months Post-treatment (Month 5)
|
1.44 units on a scale
Standard Deviation 1.01
|
—
|
SECONDARY outcome
Timeframe: Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent participants who completed the indicated study visit and completed the survey. One participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5. This survey was not administered to parents.
The Treatment Evaluation Inventory-Short Form is completed at the end of treatment. It includes 9 items adapted to be specific to pediatric pain. Items are rated on a 5-point Likert scale ranging from 1 to 5. Total scores range from 9 to 45. Higher scores indicate increased acceptability with the study treatment.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=11 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Treatment Evaluation Inventory-Short Form (TEI-SF) Score
Post-treatment (Week 8)
|
34.36 score on a scale
Standard Deviation 4.23
|
—
|
|
Treatment Evaluation Inventory-Short Form (TEI-SF) Score
3 Months Post-treatment (Month 5)
|
33.30 score on a scale
Standard Deviation 3.23
|
—
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)Population: The analysis population includes adolescent participants who completed the indicated study visit and completed the survey. One participant withdrew prior to the post-treatment assessment at Week 8 and an additional participant declined to complete the surveys at the 3 months post-treatment assessment at Month 5.
Fear of movement related to fear of pain is assessed with the Tampa Scale of Kinesiophobia (TSK) instrument. The TSK is a 17-item questionnaire where responses are given on a 4-point Likert scale. Responses of "strongly agree" are coded as 1 and responses of "strongly agree" are coded as 4. Total scores range from 17 to 68 where higher scores indicate greater kinesiophobia.
Outcome measures
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 Participants
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
I-STRONG for Parents of Adolescents With SCD
Parents of adolescents with sickle cell disease participating in the I-STRONG intervention. Parents are enrolled when the adolescent is under the age of 18. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Parents attend 6 of the 16 sessions.
|
|---|---|---|
|
Tampa Scale of Kinesiophobia (TSK) Score
Baseline
|
25.42 score on a scale
Standard Deviation 6.93
|
—
|
|
Tampa Scale of Kinesiophobia (TSK) Score
Post-treatment (Week 8)
|
25.82 score on a scale
Standard Deviation 7.24
|
—
|
|
Tampa Scale of Kinesiophobia (TSK) Score
3 Months Post-treatment (Month 5)
|
24.00 score on a scale
Standard Deviation 6.78
|
—
|
Adverse Events
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 participants at risk
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
|---|---|
|
General disorders
Hospitalization due to pain crisis
|
33.3%
4/12 • Number of events 5 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
General disorders
Hospitalization due to body pain and sinus pressure
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Infections and infestations
Hospitalization due to COVID-19
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization due to pulled muscle with back pain
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
Other adverse events
| Measure |
I-STRONG for Adolescents With Sickle Cell Disease (SCD)
n=12 participants at risk
Adolescents with sickle cell disease participating in the I-STRONG intervention. I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend each of the 16 sessions.
|
|---|---|
|
General disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 2 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Musculoskeletal and connective tissue disorders
Chest pain with back pain
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
General disorders
Headache
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Musculoskeletal and connective tissue disorders
Mild bone pain
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness in lower limb
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
3/12 • Number of events 3 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Number of events 2 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
General disorders
Pain crisis
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Psychiatric disorders
Passive suicidal ideation
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Musculoskeletal and connective tissue disorders
Sprained ankle
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
|
Social circumstances
Stress
|
8.3%
1/12 • Number of events 1 • Information on adverse events was collected from adolescent participants beginning at the baseline assessment and continued through the final assessment at the 3-month post-treatment study visit (up to 5 months).
Adverse events were not collected from parents of adolescent participants. Adverse events were not collected from Aim 1 participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place