- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580915
Effectiveness of a Functional Literacy Program for Formerly Homeless Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sixty-five percent of homeless adults are reported to be illiterate or marginally literate. The lack of literacy in a high technological society negatively impacts this population's ability to participate in daily life activities including finding and maintaining employment, renting and maintaining an apartment, seeking health care, using public transportation, and managing finances. Poor literacy marginalizes this population from societal participation and maintains this group in a state of lack and deficiency.
A literacy program will be delivered to participants who are formerly homeless and now residing in supported shelter. Participants will be randomly assigned to an intervention (n=20) or control (n=20) group. The intervention group will receive the functional literacy intervention over 8 weeks, twice weekly. Intervention sessions will allow participants to learn literacy skills within the context of real-life daily activities like grocery shopping, preparing a meal, and purchasing subway cards. Control group participants will not receive intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resident of a supported shelter environment (after homelessness)
- Self-reported difficulty with basic reading skills needed to participate in desired daily life activities
- English-speaking
Exclusion Criteria:
- Severe behavioral management disorder that would make cooperation and direction following problematic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Functional Literacy Intervention
The intervention group will receive the functional literacy program in which, in small groups, participants learn literacy skills in the context of daily life activities such as shopping, meal preparation, and transportation use.
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The intervention will be provided twice weekly in 2-hour sessions, over 8 weeks.
The 16 intervention sessions will provide the opportunity for participants to learn functional literacy skills to (1) manage an apartment, (2) access community resources, (3) manage finances, (4) access free recreational activities.
All sessions will address literacy skills needed to complete basic daily life activities in the home and community environments.
Literacy skills will first be learned and practiced within the supported shelter, and then extended to the community.
The control group will receive the usual housing services without additional intervention.
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Active Comparator: Functional Literacy Control
The control group will not receive intervention but the Usual Care Management Services.
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The control group will receive the usual housing services without additional intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Canadian Occupational Performance Measure (COPM) score
Time Frame: 1-week post-intervention
|
The Canadian Occupational Performance Measure (COPM) is a 5-item, 10-point rating scale (1=most important, 10=least important) designed to be completed conjointly by a therapist and participant, and requires approximately 30 minutes to administer.
The scale allows participants to identify and prioritize the most important problems impacting daily function and can be used with clients of all ages and diagnoses.
Participants are asked to identify the five most critical problems impeding functional performance in the areas of self-care, productivity, and leisure.
After the identification of five problems, participants are asked to rate both performance and satisfaction levels of the identified activities on a 10-point scale (1=not satisfied; 10=extremely satisfied).
An open-ended narrative section is provided to allow therapists to record participant comments.
The COPM is intended to be used pre- and post-intervention.
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1-week post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inventory of Reading Occupations (IRO) score
Time Frame: 1-week post-intervention
|
The IRO-Adult identifies reading materials from a list of 14 categories (e.g., financial records, federal/state aid documents, food and nutrition labels) that participants access as part of daily occupations.
Two sections include Reading Categories (having 14 items) and Dimensions of Reading Participation (consisting of 5 dimensions with two open-ended questions and three 5-point Likert scale items; scores of 10+ = higher reading proficiency).
For each client-identified reading category, participants are asked a series of questions about the 5 dimensions of reading participation: (1) reading material type; (2) frequency of access; (3) effectiveness, efficiency, and satisfaction; (4) importance of reading material in daily life; and (5) strategies and supports needed to access).
The IRO-Adult descriptively assesses participants' relative mastery (effectiveness, efficiency, satisfaction) in functional literacy in relation to occupational participation.
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1-week post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sharon Gutman, MD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AAAR8206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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