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

• ClinicalTrials.gov Identifier: NCT02273310
• Recruitment Status: Completed
• First Posted: October 23, 2014
• Results First Posted: January 7, 2016
• Last Update Posted: January 7, 2016
• Sponsor: University of Pennsylvania
• Collaborators: Drexel University; National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of Pennsylvania

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Sickle Cell Disease
• Intervention: Behavioral: Problem-Solving Skills Training for Disease Management
• Enrollment: 83

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Families Taking Control	Delayed Intervention Control
Arm/Group Description	Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
Period Title: Overall Study
Started	42	41
Completed	24	38
Not Completed	18	3

Baseline Characteristics

Arm/Group Title		Families Taking Control	Delayed Intervention Control	Total
Arm/Group Description		Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.	Total of all reporting groups
Overall Number of Baseline Participants		42	41	83
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	42 participants	41 participants	83 participants
		8.29 (2.12)	8.66 (2.10)	8.47 (2.11)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants	41 participants	83 participants
	Female	21 50.0%	20 48.8%	41 49.4%
	Male	21 50.0%	21 51.2%	42 50.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	42 participants	41 participants	83 participants
		42	41	83

Outcome Measures

1. Primary Outcome

Title	Child-Reported Health Related Quality of Life-School Functioning Subscale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Families Taking Control	Delayed Intervention Control
Arm/Group Description:	Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
Overall Number of Participants Analyzed	24	38
Mean (Standard Deviation); Unit of Measure: units on a scale
	60.40 (23.89)	64.60 (16.94)

2. Secondary Outcome

Title	School Functioning-Absences
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Families Taking Control	Delayed Intervention Control
Arm/Group Description:	Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
Overall Number of Participants Analyzed	24	38
Mean (Standard Deviation); Unit of Measure: Weeks (1 week = 7 days)
	0.48 (0.77)	1.10 (1.03)

3. Secondary Outcome

Title	Number of Accommodations Provided to Families by Schools
Description	Number of Accommodations Provided to Families by Schools As reported by caregivers
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Families Taking Control	Delayed Intervention Control
Arm/Group Description:	Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
Overall Number of Participants Analyzed	24	38
Mean (Standard Deviation); Unit of Measure: Number of Accommodations
	1.44 (1.35)	1.38 (1.17)

4. Secondary Outcome

Title	Acceptability of Intervention
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Families Taking Control
Arm/Group Description:	Families participate in a 1 day Problem-Solving Skills training for disease management intervention Problem-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.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: units on a scale
Caregiver-Interesting	4.71 (0.46)
Caregiver-Useful	4.36 (0.68)
Child-Interesting	4.71 (0.85)
Child-Useful	4.39 (1.17)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Families Taking Control	Delayed Intervention Control
Arm/Group Description	Families participate in a 1 day problem solving skills training intervention Problem Solving Training for Disease Management	Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
All-Cause Mortality
	Families Taking Control	Delayed Intervention Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Families Taking Control	Delayed Intervention Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/42 (0.00%)	0/41 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Families Taking Control	Delayed Intervention Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/42 (0.00%)	0/41 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Lamia Barakat, Ph.D.
• Organization: The Children's Hospital of Philadelphia/Perleman School of Medicine of The University of Pennsylvania
• Phone: 267-426-8135
• EMail: barakat@email.chop.edu

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02273310
• Other Study ID Numbers: U54HL070585 ( U.S. NIH Grant/Contract ); U54HL070585 ( U.S. NIH Grant/Contract )
• First Submitted: October 21, 2014
• First Posted: October 23, 2014
• Results First Submitted: October 29, 2014
• Results First Posted: January 7, 2016
• Last Update Posted: January 7, 2016