Trial Outcomes & Findings for Breathe With Ease: A Unique Approach to Managing Stress (BEAMS) (NCT NCT02374138)

NCT ID: NCT02374138

Last Updated: 2019-09-23

Results Overview

Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 217 participants
• Primary outcome timeframe: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
• Results posted on: 2019-09-23

Participant Flow

Participant milestones

Measure	Usual Care IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Six Month Follow Up STARTED	110	107
Six Month Follow Up COMPLETED	102	93
Six Month Follow Up NOT COMPLETED	8	14
Twelve Month FollowUp STARTED	110	107
Twelve Month FollowUp COMPLETED	101	95
Twelve Month FollowUp NOT COMPLETED	9	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)

Baseline characteristics by cohort

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."	Total n=217 Participants Total of all reporting groups
Age, Categorical Parent Participants · <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Parent Participants · Between 18 and 65 years	108 Participants n=5 Participants	104 Participants n=7 Participants	212 Participants n=5 Participants
Age, Categorical Parent Participants · >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical Child Participants · <=18 years	110 Participants n=5 Participants	107 Participants n=7 Participants	217 Participants n=5 Participants
Age, Categorical Child Participants · Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Child Participants · >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous Parent Participants	33.2 years STANDARD_DEVIATION 8.9 • n=5 Participants	34.3 years STANDARD_DEVIATION 10.0 • n=7 Participants	33.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Age, Continuous Child Participants	6.4 years STANDARD_DEVIATION 2.3 • n=5 Participants	6.8 years STANDARD_DEVIATION 2.3 • n=7 Participants	6.6 years STANDARD_DEVIATION 2.3 • n=5 Participants
Sex: Female, Male Parent Participants · Female	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Parent Participants · Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Child Participants · Female	42 Participants n=5 Participants	43 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Child Participants · Male	68 Participants n=5 Participants	64 Participants n=7 Participants	132 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	107 participants n=7 Participants	217 participants n=5 Participants

PRIMARY outcome

Timeframe: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)

Population: Randomized participants with follow up available at each time period.

Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Symptom-free Days in the Last 14 Days	11.4 days in prior 14d Standard Deviation 3.3	11.6 days in prior 14d Standard Deviation 3.0

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

Population: Participants with data available at each follow up time point

Nights of asthma symptoms in prior 14d

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Asthma Morbidity - Nighttime Asthma Symptoms Nighttime asthma symptoms at 6 Month FU	1.7 days in prior 14d Standard Deviation 2.9	1.9 days in prior 14d Standard Deviation 3.2
Asthma Morbidity - Nighttime Asthma Symptoms Nighttime asthma symptoms at 12 Month FU	2.1 days in prior 14d Standard Deviation 3.2	1.5 days in prior 14d Standard Deviation 2.3

SECONDARY outcome

Timeframe: Repeated Measures at 3, 6, and 12 months

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

Population: Participants with Follow Up Data Available at Each Time Point

Reported use of inhaled corticosteroids and LTRA in past two days

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Asthma Medication Adherence ICS use at 6 Month Follow Up	68 Participants	68 Participants
Asthma Medication Adherence ICS use at 12 Month Follow up	55 Participants	61 Participants
Asthma Medication Adherence LTRA use at 6 Month Follow Up	14 Participants	16 Participants
Asthma Medication Adherence LTRA use at 12 Month Follow Up	20 Participants	18 Participants

SECONDARY outcome

Timeframe: 12 months after enrollment

Population: Participants with follow up available at each time point

Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Health Care Utilization - Emergency Department Visits for Asthma ED Visits between 6m and 12m Follow up	0.33 Visits Standard Error 0.65	0.42 Visits Standard Error 0.75
Health Care Utilization - Emergency Department Visits for Asthma ED Visits between enrollment and 6m Follow Up	0.32 Visits Standard Error 0.68	0.32 Visits Standard Error 0.77

SECONDARY outcome

Timeframe: Assessed at 6m and 12m following enrollment

Population: Participants with data available at each time point

Courses of systemic steroids over 12m follow up period

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Asthma Exacerbations - Courses of Systemic Steroids Courses of systemic steroids over 6 Months	0.30 Courses of systemic steroids Standard Error 0.63	0.29 Courses of systemic steroids Standard Error 0.68
Asthma Exacerbations - Courses of Systemic Steroids Courses of systemic steroids btwn 6m and 12m FU	0.26 Courses of systemic steroids Standard Error 0.61	0.30 Courses of systemic steroids Standard Error 0.67

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

Population: Number of participants with follow up available at each time point.

Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Parental Stress PSS Score at 6 Month Follow Up	10.4 units on a scale Standard Deviation 7.3	11.4 units on a scale Standard Deviation 7.1
Parental Stress PSS Score at 12 Month Follow up	10.3 units on a scale Standard Deviation 7.2	12.6 units on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

Population: Participants available at each follow up time point.

Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Parental Depression CES-D 10 score at 6 Month Follow up	6.8 units on a scale Standard Deviation 4.8	7.4 units on a scale Standard Deviation 5.2
Parental Depression CES-D 10 score at 12 Month Follow up	7.6 units on a scale Standard Deviation 5.7	8.0 units on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

Population: Participants available at each time point

PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Child Anxiety Score at 6 Month Follow up	42.5 units on a scale Standard Deviation 9.6	40.4 units on a scale Standard Deviation 7.8
Child Anxiety Score at 12 Month Follow Up	43.1 units on a scale Standard Deviation 10.2	41.5 units on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

Population: Participants available at each time point

PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Child Depression Score at 6 Month Follow Up	41.1 units on a scale Standard Deviation 7.7	40.6 units on a scale Standard Deviation 7.0
Child Depression Score at 12 Month Follow Up	42.3 units on a scale Standard Deviation 9.1	41.2 units on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

Population: Participants with follow up available at each time point. Note use of modified scale.

Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Caregiver Quality of Life Score at 6 month Follow Up	57.6 units on a scale Standard Deviation 8.8	58.9 units on a scale Standard Deviation 8.1
Caregiver Quality of Life Score at 12 Month Follow Up	58.1 units on a scale Standard Deviation 8.4	57.8 units on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: 12m follow up period

Population: Participants available at each time point

Safety data: Number of Participants with AEs and SAEs

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Number of Participants With AEs and SAEs 6 Month Follow Up	0 Participants	0 Participants
Number of Participants With AEs and SAEs 12 Month Follow up	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12m follow-up period

Population: Data were not collected

Analysis of costs of care in both groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months

Population: We are unable to analyze or report the data because it was not systematically collected.

parent report of cigarettes smoked per day

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Repeated measures at 12m FU (6m data used for repeated measures)

Population: While we have collected this data, its analysis will be complex and require significant resources. We lack those resources at this time. We may at some point in the future return to this analysis.

Brief COPE

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months

Population: We are unable to analyze or report the data because it was not systematically collected.

Interpersonal Mindfulness in Parenting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Repeated Measures at 6 and 12 months

Population: Participants with follow up available at each time point

Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Parental Resilience Score on LOT-R at 12 month Follow Up	16.7 units on a scale Standard Deviation 3.3	16.9 units on a scale Standard Deviation 4.1
Parental Resilience Score on LOT-R at 6 Month Follow Up	16.1 units on a scale Standard Deviation 3.3	16.5 units on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: Assessed at 6m and 12m after enrollment

Population: Participants with data available at each time point

Number of participants with hospital admissions due to exacerbations

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Exacerbations - Hospital Admissions Pts hospitalized btwn enrollment and 6m FU	5 Participants	4 Participants
Exacerbations - Hospital Admissions Pts hospitalized btwn 6m and 12m FU	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Repeated Measures at 12 months (with data also assessed at 3m and 6m)

Population: Participants with data available at 12m follow up

Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications

Outcome measures

Measure	Usual Care n=101 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=95 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Symptom-free Days in the Last 14 Days	10.9 days Standard Deviation 3.7	11.8 days Standard Deviation 2.9

SECONDARY outcome

Timeframe: Repeated measures at 6 and 12 months (3m data collected for repeated measures)

Population: Participants with data available at each follow up time point

Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use Daytime asthma symptoms at 6m FU	1.64 days in prior 14d Standard Deviation 2.48	1.83 days in prior 14d Standard Deviation 2.66
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use Daytime asthma symptoms at 12m FU	2.31 days in prior 14d Standard Deviation 3.24	1.57 days in prior 14d Standard Deviation 2.39
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use Days of activity limitation at 6m	1.42 days in prior 14d Standard Deviation 2.53	1.04 days in prior 14d Standard Deviation 1.74
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use Days of activity limitation at 12m	1.66 days in prior 14d Standard Deviation 2.99	1.12 days in prior 14d Standard Deviation 2.31
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use Days of quick relief medicine use at 6m	2.75 days in prior 14d Standard Deviation 3.59	2.96 days in prior 14d Standard Deviation 4.26
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use Days of quick relief medicine use at 12m	3.40 days in prior 14d Standard Deviation 4.16	2.85 days in prior 14d Standard Deviation 3.99

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Sociodemographics Parent Race : African American	110 Participants	107 Participants
Sociodemographics Child Race : African American	110 Participants	107 Participants
Sociodemographics Parent Ethnicity: Non-Hispanic	110 Participants	106 Participants
Sociodemographics Child Ethnicity: Non-Hispanic	110 Participants	106 Participants
Sociodemographics Public Insurance	110 Participants	107 Participants
Sociodemographics Parent Education: Grade 1-11	9 Participants	19 Participants
Sociodemographics Parent Education: GED or 12th grade	44 Participants	41 Participants
Sociodemographics Parent Education: Some college/associates degree	39 Participants	33 Participants
Sociodemographics Parent Education: College Graduate	18 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

Population: Number of participants with follow up data available at each time point.

Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?" A positive response on either or both questions was considered positive exposure.

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Number of Participants With Positive Smoke Exposure 12 Month Follow up	13 Participants	9 Participants
Number of Participants With Positive Smoke Exposure 6 Month Follow Up	13 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Single Item Literacy Screener (SILS)

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Parental Health Literacy Never needs assistance	98 Participants	95 Participants
Parental Health Literacy Needs any assistance	12 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at 6m and 12m following enrollment

Population: Participants with data available at each follow up point

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Use of Existing Ancillary Services Parent use of mental health resources at 6 Months	19 Participants	30 Participants
Use of Existing Ancillary Services Parent use of mental health resources at 12 Months	28 Participants	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.

Outcome measures

Measure	Usual Care n=110 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention n=107 Participants Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Parental Resilience	16.1 units on a scale Standard Deviation 3.3	16.2 units on a scale Standard Deviation 3.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 month intervention period

Population: Intervention group only

Completion of intervention sessions

Outcome measures

Measure	Usual Care n=107 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Intervention Component Uptake Completed 0 Intervention Sessions	8 Participants	—
Intervention Component Uptake Completed 1 Intervention Session	15 Participants	—
Intervention Component Uptake Completed 2 Intervention Sessions	4 Participants	—
Intervention Component Uptake Completed 3 Intervention Sessions	5 Participants	—
Intervention Component Uptake Completed 4 Intervention Sessions	75 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 month intervention period

Population: Participants with data available at 6 month follow up

Brief survey of satisfaction with intervention components.

Outcome measures

Measure	Usual Care n=91 Participants IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination	Intervention Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Intervention Satisfaction "Very Much" satisfied with individual sessions	82 Participants	—
Intervention Satisfaction "Very Much" satisfied with delivery of sessions	86 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 month intervention period

Checklist of staff's fidelity to individual components of intervention protocol

Outcome measures

Outcome data not reported

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

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

Stephen Teach, MD, MPH

Children's Research Institute

Phone: 202 476 5134

Email: steach@childrensnational.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place