Trial Outcomes & Findings for Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma (NCT NCT00384813)

Results Overview

Family Asthma Management System Scale is semi-structured clinical interview that includes open-ended questions assessing family management of pediatric asthma. The interview is recorded and rated using a standard manual on seven core subscales and two optional subscales.The interview is recorded and rated on seven to nine 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management (1 being the worse asthma management and 9 being the best asthma management). Mean of all of the subscales used to compute a total score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

4 months from baseline

Results posted on

2014-07-28

Participant Flow

Families were recruited from an urban hospital and a residential camp for children with asthma. Initial eligibility criteria : (a) residence in one of two urban counties, (b) child age 8 to 13, (c) Medicaid or State Children's Health Insurance Program, (d) current prescription of a daily controller agent, and (e) poorly controlled asthma.

Caregivers of children meeting initial eligibility criteria were interviewed briefly by phone; those answering affirmatively to either of two stress questions were invited to participate in a Screening Assessment. Caregivers with an elevated score on a stress measure were invited to participate in the trial.

Participant milestones

Participant milestones
Measure	1: Home-based Family Intervention Home-based family intervention Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months	2: Enhanced Treatment As Usual Enhanced Treatment As Usual (1 home visit) Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
Overall Study STARTED	23	20
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1: Home-based Family Intervention n=21 Participants Home-based family intervention Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months	2: Enhanced Treatment As Usual n=20 Participants Enhanced Treatment As Usual (1 home visit) Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist	Total n=41 Participants Total of all reporting groups
Age, Continuous	10.4 years STANDARD_DEVIATION 1.4 • n=5 Participants	10.6 years STANDARD_DEVIATION 1.9 • n=7 Participants	10.5 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months from baseline

Family Asthma Management System Scale is semi-structured clinical interview that includes open-ended questions assessing family management of pediatric asthma. The interview is recorded and rated using a standard manual on seven core subscales and two optional subscales.The interview is recorded and rated on seven to nine 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management (1 being the worse asthma management and 9 being the best asthma management). Mean of all of the subscales used to compute a total score.

Outcome measures

Outcome measures
Measure	1: Home-based Family Intervention n=21 Participants Home-based family intervention Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months	2: Enhanced Treatment As Usual n=20 Participants Enhanced Treatment As Usual (1 home visit) Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
Mean Score on the Family Asthma Management System Scale (FAMSS)	4.9 units on a scale Standard Error .293	4.1 units on a scale Standard Error .300

PRIMARY outcome

Timeframe: 4 months, 10 months

Observational rating scale assessing MDI/spacer technique

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 months, 10 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months, 10 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months, 10 months

Outcome measures

Outcome data not reported

Adverse Events

1: Home-based Family Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2: Enhanced Treatment As Usual

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

Marianne Celano, PhD, ABPP

Emory University School of Medicine

Phone: 404-778-1536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place