Sickle Cell Disease
Conditions
Brief summary
This study aims to develop an effective, brief, family-based intervention targeting quality of life and school functioning for youth with sickle cell disease. Utilizing a randomized, delayed control group intervention methodology, the present study will systematically document the effectiveness of a family-based, one-day intervention plus booster phone calls to improve quality of life and increase school functioning for children with sickle cell disease transitioning to school and their families.
Detailed description
Families Taking Control-School-age Intervention (FTC) will provide education and problem solving training for disease management and school functioning. In 4 sessions offered over the course of one day, families (patient, caregivers, and school-age siblings) will work together and individually to learn and apply the problem solving skills training model to relevant examples and family-specific problems, culminating in an outline of family goals to target after the intervention. The three booster phone calls will provide support to families in implementing the problem-solving model by addressing and refining goals and trouble-shooting barriers to implementation. Children and caregivers completed measures at baseline (prior to intervention participation) and 6 months later.
Interventions
BEHAVIORALProblem-Solving Skills Training for Disease Management
Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease.
Sponsors
Drexel University
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
English speaking, treated at one of two participating Sickle Cell Centers -
Exclusion criteria
severe developmental delay or children/caregivers with severe psychopathology that would adversely affect their ability to participate \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child-Reported Health Related Quality of Life-School Functioning Subscale | 6 months | Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| School Functioning-Absences | 6 months | School Absences reported by caregivers, Caregivers reported absences categorically (0-7 days = 1, 7-14 days = 2, etc). Higher numbers indicate more absences. |
| Number of Accommodations Provided to Families by Schools | 6 months | Number of Accommodations Provided to Families by Schools As reported by caregivers |
| Acceptability of Intervention | post intervention | Families in the FTC group rated acceptability of participating in the intervention workshop. This measure was completed at the workshop (between baseline and 6 month assessments). This measure utilized a 5-point Likert-type scale (with the possible range of scores as 1-5), with higher scores indicating more positive feedback. Individual item scores are presented here. Participant results indicated a range of scores from from 2-5. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Families Taking Control Families participate in a 1 day problem solving skills training intervention
Problem Solving Training for Disease Management | 42 |
| Delayed Intervention Control Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2. | 41 |
| Total | 83 |
Baseline characteristics
| Characteristic | Families Taking Control | Delayed Intervention Control | Total |
|---|---|---|---|
| Age, Continuous | 8.29 years STANDARD_DEVIATION 2.12 | 8.66 years STANDARD_DEVIATION 2.1 | 8.47 years STANDARD_DEVIATION 2.11 |
| Region of Enrollment United States | 42 participants | 41 participants | 83 participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 41 |
| serious Total, serious adverse events | 0 / 42 | 0 / 41 |
Outcome results
Primary
Child-Reported Health Related Quality of Life-School Functioning Subscale
Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Families Taking Control | Child-Reported Health Related Quality of Life-School Functioning Subscale | 60.40 units on a scale | Standard Deviation 23.89 |
| Delayed Intervention Control | Child-Reported Health Related Quality of Life-School Functioning Subscale | 64.60 units on a scale | Standard Deviation 16.94 |
Secondary
Acceptability of Intervention
Families in the FTC group rated acceptability of participating in the intervention workshop. This measure was completed at the workshop (between baseline and 6 month assessments). This measure utilized a 5-point Likert-type scale (with the possible range of scores as 1-5), with higher scores indicating more positive feedback. Individual item scores are presented here. Participant results indicated a range of scores from from 2-5.
Time frame: post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Families Taking Control | Acceptability of Intervention | Caregiver-Interesting | 4.71 units on a scale | Standard Deviation 0.46 |
| Families Taking Control | Acceptability of Intervention | Caregiver-Useful | 4.36 units on a scale | Standard Deviation 0.68 |
| Families Taking Control | Acceptability of Intervention | Child-Interesting | 4.71 units on a scale | Standard Deviation 0.85 |
| Families Taking Control | Acceptability of Intervention | Child-Useful | 4.39 units on a scale | Standard Deviation 1.17 |
Secondary
Number of Accommodations Provided to Families by Schools
Number of Accommodations Provided to Families by Schools As reported by caregivers
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Families Taking Control | Number of Accommodations Provided to Families by Schools | 1.44 Number of Accommodations | Standard Deviation 1.35 |
| Delayed Intervention Control | Number of Accommodations Provided to Families by Schools | 1.38 Number of Accommodations | Standard Deviation 1.17 |
Secondary
School Functioning-Absences
School Absences reported by caregivers, Caregivers reported absences categorically (0-7 days = 1, 7-14 days = 2, etc). Higher numbers indicate more absences.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Families Taking Control | School Functioning-Absences | 0.48 Weeks (1 week = 7 days) | Standard Deviation 0.77 |
| Delayed Intervention Control | School Functioning-Absences | 1.10 Weeks (1 week = 7 days) | Standard Deviation 1.03 |