Clinical trial NCT05832437: BREATHE-Peds Pilot- II III Trial and Post Trial
Official title: The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: Asthma
Adolescents
Dyads
Shared decision-making
Minority health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-04-27
Enrollment: 127
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (FQHCs) in urban communities. Aim 1 (Phase I) involves developing the intervention through focus groups with early adolescents and caregivers. Aims 2 and 3 (Phase II) involve preliminary testing of the intervention through a pilot randomized controlled trial. This record is for Phase II and III only

Detailed description: Despite high asthma prevalence and morbidity among adolescents (highest among Black and Hispanic youth and early adolescents aged 10-14), there is a lack of developmentally appropriate interventions for this at-risk group. Racial and ethnic minority early adolescents have sub-optimal asthma self-management. Critical health behaviors that emerge during early adolescence affect lifelong patterns; therefore, early adolescence offers a unique opportunity to intervene. Additionally, successful self-management requires the right division of responsibility between adolescents and their caregivers. Thus, intervening simultaneously with early adolescents and their caregivers who can help support the adolescent's growing autonomy to self-manage their condition has the potential for a synergistic effect.

Prior studies have demonstrated the effects of improved asthma control of BREATHE, a brief one-time shared decision-making intervention for Black adults with uncontrolled asthma that utilizes motivational interviewing delivered by primary care providers. This study (i.e., Phase II and Phase III) ) a pilot validation phase will conduct a group-randomized trial in two FQHCs with 85 dyads treated by 8 PCPs (10 dyads/PCP) randomized to 1 of 2 study arms: (a) BREATHE-PEDS-Peds (n=42 dyads), or (b) dose-matched attention control (n=43 dyads). Post-trial interviews with PCPs, caregivers, and their children to evaluate satisfaction with the intervention will be conducted; caregiver-child dyads will be followed for 3 months post-intervention to assess the impact of BREATHE-PEDS-Peds on asthma outcomes.

Eligibility criteria: Inclusion Criteria (Dyad participants):

Dyad (caregiver/child) participants will

1. Early adolescents (10-14 years of age) or the caregiver of early adolescents (10-14 years of age)
2. Have or the caregiver of a child that has clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 12 months)
3. Receive asthma care at a partner FQHC and
4. Child screens positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and child or caregiver has erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey.

Inclusion Criterion (clinicians):

1. Those who manage a panel of pediatric asthma patients at partner FQHC.

Exclusion Criteria (Dyad participants):

1. Non-English speaking
2. Serious mental health conditions that preclude completion of study procedures or confound analyses or participation in a listening session

Primary outcomes:
measure: Mean Asthma Control Questionnaire Score
timeFrame: Up to 3 months post intervention
Secondary outcomes:
measure: Mean Shared Decision Making-Questionnaire-9 Score
timeFrame: Baseline (immediately post-intervention)
measure: Mean Medication Adherence Report Scale - Asthma Score
timeFrame: Up to 3 months post intervention
measure: Mean Asthma Quality of Life Questionnaire Score
timeFrame: Up to 3 months post intervention
measure: Mean Asthma Impairment and Risk Questionnaire Score
timeFrame: Up to 3 months post intervention
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Urban Health Plan: Adolescent Health and Wellness
state: New York
city: Bronx
country: United States
facility: Urban Health Plan: El Nuevo San Juan
state: New York
city: Bronx
country: United States
facility: Urban Health Plan: Bella Vista
state: New York
Study officials:
affiliation: Columbia University
name: Maureen George, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Jean-Marie Bruzzese, PhD
role: PRINCIPAL_INVESTIGATOR
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