STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
North Carolina
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Durham, North Carolina, United States, 27701
- Excelsior School
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- In the range of 8 - 12 years of age,
- Child has a diagnosis of asthma or reactive airway and prescribed a controller medication or have intermittent symptoms,
- Child has at least slightly elevated anxiety or depressive symptoms upon screening at enrollment,
- The parent/caregiver can understand and answer the survey questions in English; child can understand English in a small group setting and can answer survey questions in English,
- The consenting parent/caregiver has at least equal responsibility for the day-to-day management of the child's asthma.
Exclusion Criteria:
- Child has other pulmonary conditions (e.g., cystic fibrosis/pulmonary fibrosis),
- Child or parent/caregiver cannot answer the survey questions due to a cognitive delay.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
OTHER: One group pilot
The experimental group will receive the intervention, which is an 8-week (30 minute session per week) asthma educational and cognitive behavioral skills program.
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STRONGer (Successes/Strengths, Triggers, Remember your medications, Ongoing communication, Never give up!, Gratitude) Together is an asthma educational and cognitive behavioral skills intervention for children between 8 - 12 years of age.
The intervention is implemented in small groups in 30-minute sessions.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the Intervention
Time Frame: 8-weeks
|
Feasibility will be established if 80% of the participants attend 6 out of 8 sessions.
|
8-weeks
|
|
Acceptability related to the Intervention
Time Frame: 8 weeks
|
Acceptability will be established if 80% of the child participants practice the skills or practice sheets.
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8 weeks
|
|
Acceptability of the Intervention - for the Child Participants
Time Frame: 8 weeks
|
Questions relate to satisfaction with the program and general like/dislike (rated 0 - 5; higher score reflects more satisfaction) and qualitative questions about what participants liked or would change about the program.
|
8 weeks
|
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Acceptability of the Intervention - for the Parent/Caregiver Participants
Time Frame: 8 weeks
|
Questions relate to overall satisfaction with the program (0 - 5; higher score reflects greater satisfaction) and qualitative questions about if/what their child learned from the program.
|
8 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Management Self-Efficacy - Child
Time Frame: From baseline to post-intervention (8-weeks) and at 16 weeks post-intervention.
|
The Child Asthma Self-Efficacy (CASE) scale (14 items) measures children's perception of their own ability to manage asthma (e.g., "...can tell when a serious breathing problem can be controlled at home") and assesses asthma symptoms, health status, and impact of the child's illness on the family (Bursch, Schwankovsky, Gilbert, & Zeiger, 1999).
Answers are scored 1 - 5; higher scores indicate greater self-efficacy.
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From baseline to post-intervention (8-weeks) and at 16 weeks post-intervention.
|
|
Anxiety Measure (Screen for Child Anxiety Related Disorders [SCARED]) - Child
Time Frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
The SCARED measure assesses five factors including panic/somatic, general anxiety disorder, separation anxiety, social phobia, and school phobia; it has been validated with children and adolescents ages 8 - 19 years (Beidas et al., 2015; Hale, Crocetti, Raaijmakers, & Meeus, 2011; Birmaher et al., 1999).
Items are scored from 0 (not true or hardly ever true) to 2 (very true or often true; Birmaher et al., 1999).
Higher scores indicate greater anxiety with a total score of 25 as having a potential anxiety disorder and 30 as more specific.
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From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
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Depression Measure (Patient-Reported Outcomes Measurement Information System [PROMIS]- Child Depression Short Form)
Time Frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
The PROMIS Child Depression Short Form Assesses negative mood (e.g., sadness), decrease in positive affect (e.g., loss of interest), negative views of self (e.g., worthlessness), and negative social cognition (e.g., loneliness, interpersonal alienation; Assessment Center, n.d.).
Items are scored from 0 (never) to 4 (almost always).
Higher scores indicate greater depressive symptoms.
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From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
|
Asthma Illness Representations - Child Version (AIRS-C)
Time Frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
The AIRS-C is a 17-item measure designed to identify barriers to and risk factors for under-utilization of controller medications.
Higher scores indicate closer alignment with the professional model of asthma management.
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From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
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Pediatric Asthma Quality of Life Questionnaire (PAQLQ) - Child
Time Frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
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The PAQLQ 14-item Likert-type scale is validated for children between ages 7 - 17 years (Juniper, Guyatt, Ferrie, & Griffith, 1993) and measures the functional problems (symptoms, activity limitations, emotional function) that are troublesome to children with asthma (Juniper et al., 1993).
Items are scored from 1 (extremely bothered) to 7 (not bothered at all) and the total score is the mean of items.
Higher scores denote better QoL.
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From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
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Peak Flow - Child
Time Frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
The child participants will be asked to complete peak flow assessments (blowing into the meter) during the study to evaluate lung function.
A higher number indicates better lung function.
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From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
|
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Pediatric Symptom Checklist - completed by the Parent/Caregiver
Time Frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
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The PSC includes 17 Likert type questions to assess internalizing, attention, and externalizing problems (Murphy et al., 2016).
Items are scored from 0 (never) to 2 (often; α = .89).
Examples of questions include "My child feels sad, unhappy" and "Daydreams too much."
Higher scores indicate more symptoms.
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From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
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Asthma Control Test - Combined Child and Parent/Caregiver
Time Frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
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The C-ACT consists of questions for children (ages 4-11 years; 4 items) and parents (3 items) and the ACT (for individuals 12 years and older) has similar questions which are self-administered.
This instrument assesses interference with activities, asthma symptoms, and nighttime awakenings.
The C-ACT (α = .79;
Lui et al., 2007; Lui et al., 2010) classifies children as very poorly controlled, not well-controlled, or well controlled.
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From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Colleen McGovern, PhD, University of North Carolina, Greensboro
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 19-1290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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