Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-01-10
2021-07-30
Brief Summary
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Detailed Description
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Children and adolescents with SCD and cancer may have limited access to skilled psychologists or may not be able to attend frequent in-person intervention visits to acquire skills to support psychosocial functioning. A critical barrier to helping adolescents with SCD and cancer is that there are few portable interventions that provide assistance outside of the hospital environment.
The goal of this proposal is to pilot test FOCUS (Framing Opportunities and Challenges Using Stories), an innovative and portable intervention designed to improve the psychosocial functioning of adolescents with medical conditions. The intervention involves taking and captioning purposeful photographs that align with The Hero's Journey, a guiding narrative template that chronicles a hero's passage through life's adventures and challenges, culminating in individual strength and transformation (Campbell, 1968). Preliminary data evaluating components of FOCUS revealed significant improvements in mood among healthy adolescents and young adults. Data suggest that reflecting on positive and negative daily events (e.g., via a photograph) and writing about the experiences have profound positive effects on a range of outcomes (e.g., grit, gratitude, functioning). In addition, the investigators intend to share the participants' photographs, stories, and advice on a website for other adolescents with SCD or cancer. Data indicate that prosocial behavior (e.g., providing advice to peers) and social connectedness have a number of positive outcomes. The central prediction is that FOCUS will be acceptable and feasible to deliver and that pilot data will reveal improvements in participants' psychosocial health. Achieving these aims will provide the foundational data needed for federal grant applications to evaluate FOCUS with a larger pediatric sample and other patient populations, powered to identify outcomes and mechanisms of change.
Aim. Pilot FOCUS. A pilot randomized controlled trial will compare FOCUS to standard care. Investigators will randomize a total of 60 12- to 18-year-old patients to either FOCUS intervention (n=15 with SCD; n=15 with cancer) or treatment as usual (n=15 with SCD; n=15 with cancer). Randomization will be stratified to match patients based on age, sex, and medical condition (SCD type, cancer type). FOCUS participants will engage in the intervention and complete measures for 10 days post hospital discharge. Control participants will complete similar measures but not receive the intervention. Mixed qualitative and quantitative measures of feasibility, acceptability, and preliminary outcomes will be conducted to evaluate both the intervention and study procedures.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FOCUS
Participants will complete a baseline survey battery and learn about The Hero's Journey. Starting at hospital discharge for 10 days, they will do the following: 1) identify which stage of The Hero's Journey they are experiencing; 2) take a picture of something good and write a caption describing the picture and provide advice; and 3) take a picture of something difficult or challenging during the day and write a caption for the photo and provide advice.
Daily text messages will remind participants to take the photographs, write the advice captions, upload both to the server, as well as to take a very brief daily survey. At the conclusion of day 10, participants will be asked to review their photos and captions and provide final advice in the form of a letter to other adolescents with SCD or cancer. Finally, they will complete a post-intervention battery.
FOCUS
See prior section.
Control
In a 30-min visit (in person or virtual) with adolescents during hospitalizations, we will have participants complete a baseline survey battery.
Daily text messages will remind participants to take a very brief daily survey. At the conclusion of day 10, participants will complete a post-intervention battery.
No interventions assigned to this group
Interventions
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FOCUS
See prior section.
Eligibility Criteria
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Inclusion Criteria
* 2\) inpatient at CHOA
* 3\) 12-18 years of age
* 4\) English speaking
* 5\) owns a smartphone with camera.
Exclusion Criteria
* 2\) significant documented developmental delay, autism spectrum disorder, or significant intellectual impairment, as these comorbidities may confound the study aims by impacting the dependent measures.
12 Years
18 Years
ALL
No
Sponsors
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Georgia State University
OTHER
Responsible Party
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Laura Mckee
Associate Professor
Principal Investigators
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Lindsey L Cohen, PhD
Role: PRINCIPAL_INVESTIGATOR
Georgia State University
Laura G McKee
Role: PRINCIPAL_INVESTIGATOR
Georgia State University
Locations
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Georgia State University
Atlanta, Georgia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Lindsey L Cohen, PhD
Role: primary
Chris Henrich, PhD
Role: backup
Lindsey L Cohen, PhD
Role: primary
Other Identifiers
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FOCUS
Identifier Type: -
Identifier Source: org_study_id