BREATHE-Peds Pilot- II III Trial and Post Trial

Columbia University

Status: Completed

Conditions: Asthma in Children

Treatments: Behavioral: BREATHE-Peds Intervention; Behavioral: Control Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05832437

AAAT8015-Trial & Post-Trial

1R21NR019668-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 10 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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127 participants in 2 patient groups

BREATHE-Peds intervention

Experimental group

Description:

The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.

Treatment:

Behavioral: BREATHE-Peds Intervention

Control Intervention

Active Comparator group

Description:

The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.

Treatment:

Behavioral: Control Intervention