Trial Outcomes & Findings for Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease (NCT NCT02273310)

Results Overview

Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

6 months

Results posted on

2016-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Families Taking Control Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Delayed Intervention Control Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
Overall Study STARTED	42	41
Overall Study COMPLETED	24	38
Overall Study NOT COMPLETED	18	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Families Taking Control n=42 Participants Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Delayed Intervention Control n=41 Participants Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.	Total n=83 Participants Total of all reporting groups
Age, Continuous	8.29 years STANDARD_DEVIATION 2.12 • n=5 Participants	8.66 years STANDARD_DEVIATION 2.10 • n=7 Participants	8.47 years STANDARD_DEVIATION 2.11 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	41 participants n=7 Participants	83 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.

Outcome measures

Outcome measures
Measure	Families Taking Control n=24 Participants Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Delayed Intervention Control n=38 Participants Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
Child-Reported Health Related Quality of Life-School Functioning Subscale	60.40 units on a scale Standard Deviation 23.89	64.60 units on a scale Standard Deviation 16.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Families Taking Control n=24 Participants Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Delayed Intervention Control n=38 Participants Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
School Functioning-Absences	0.48 Weeks (1 week = 7 days) Standard Deviation 0.77	1.10 Weeks (1 week = 7 days) Standard Deviation 1.03

SECONDARY outcome

Timeframe: 6 months

Number of Accommodations Provided to Families by Schools As reported by caregivers

Outcome measures

Outcome measures
Measure	Families Taking Control n=24 Participants Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Delayed Intervention Control n=38 Participants Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
Number of Accommodations Provided to Families by Schools	1.44 Number of Accommodations Standard Deviation 1.35	1.38 Number of Accommodations Standard Deviation 1.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Families Taking Control n=28 Participants Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Delayed Intervention Control Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
Acceptability of Intervention Caregiver-Interesting	4.71 units on a scale Standard Deviation 0.46	—
Acceptability of Intervention Caregiver-Useful	4.36 units on a scale Standard Deviation 0.68	—
Acceptability of Intervention Child-Interesting	4.71 units on a scale Standard Deviation 0.85	—
Acceptability of Intervention Child-Useful	4.39 units on a scale Standard Deviation 1.17	—

Adverse Events

Families Taking Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Intervention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lamia Barakat, Ph.D.

The Children's Hospital of Philadelphia/Perleman School of Medicine of The University of Pennsylvania

Phone: 267-426-8135

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place