STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression

NCT04089085 | Unknown

• 1 other identifier: 19-1290
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a one group pilot to assess the feasibility and acceptability of an 8-session intervention (STRONGer Together) for children between 8 - 12 years of age with asthma and anxiety/depressive symptoms.

Conditions

Childhood Asthma; Childhood Anxiety; Childhood Depression

Keywords

Childhood Asthma; Childhood Anxiety/depression; Educational and Behavioral Intervention for Children

Outcome Measures

Primary Outcomes (4)

• Feasibility of the Intervention

  Feasibility will be established if 80% of the participants attend 6 out of 8 sessions.

  8-weeks

• Acceptability related to the Intervention

  Acceptability will be established if 80% of the child participants practice the skills or practice sheets.

  8 weeks

• Acceptability of the Intervention - for the Child Participants

  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

• Acceptability of the Intervention - for the Parent/Caregiver Participants

  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 Outcomes (8)

• Asthma Management Self-Efficacy - Child

  From baseline to post-intervention (8-weeks) and at 16 weeks post-intervention.

• Anxiety Measure (Screen for Child Anxiety Related Disorders [SCARED]) - Child

  From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention

• Depression Measure (Patient-Reported Outcomes Measurement Information System [PROMIS]- Child Depression Short Form)

  From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention

• Asthma Illness Representations - Child Version (AIRS-C)

  From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention

• Pediatric Asthma Quality of Life Questionnaire (PAQLQ) - Child

  From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention

Study Arms (1)

One group pilot

OTHER

The experimental group will receive the intervention, which is an 8-week (30 minute session per week) asthma educational and cognitive behavioral skills program.

Behavioral: STRONGer Together

Interventions

STRONGer Together BEHAVIORAL

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.

One group pilot

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Greensboro: lead
• Sigma Theta Tau International: collaborator

Study Sites (1)

Excelsior School

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Colleen McGovern, PhD

  University of North Carolina, Greensboro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: One Group Pilot Study

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 13, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)