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| ID | Type | Description | Link |
|---|---|---|---|
| U54HL070585 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Drexel University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Families Taking Control | Experimental | Families participate in a 1 day Problem-Solving Skills training for disease management intervention |
|
| Delayed Intervention Control | No Intervention | Families are given the opportunity to complete the Problem-solving Skills training for disease management intervention after assessment time 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem-Solving Skills Training for Disease Management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Number of Accommodations Provided to Families by Schools |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Lamia Barakat, Ph.D. | The Children's Hospital of Philadelphia/University of Pennsylvania | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Families Taking Control | Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management |
| FG001 | Delayed Intervention Control | Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Families Taking Control | Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management |
| BG001 | Delayed Intervention Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Families Taking Control | Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lamia Barakat, Ph.D. | The Children's Hospital of Philadelphia/Perleman School of Medicine of The University of Pennsylvania | 267-426-8135 | barakat@email.chop.edu |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D019468 | Disease Management |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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Number of Accommodations Provided to Families by Schools As reported by caregivers |
| 6 months |
| 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. | post intervention |
Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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. | Posted | Mean | Standard Deviation | Weeks (1 week = 7 days) | 6 months |
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| Secondary | Number of Accommodations Provided to Families by Schools | Number of Accommodations Provided to Families by Schools As reported by caregivers | Posted | Mean | Standard Deviation | Number of Accommodations | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | post intervention |
|
|
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| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Delayed Intervention Control | Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2. | 0 | 41 | 0 | 41 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
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| Child-Useful |
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