LiteracyNCT03580915
Effectiveness of a Functional Literacy Program for Formerly Homeless Adults
A study testing Functional Literacy Program in people with Literacy, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to assess a functional literacy program for formerly homeless adults now residing in supported housing who have difficulty performing daily life skills requiring functional literacy (e.g., bill paying, medication management, community transportation) needed to maintain housing placements. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Literacy
- What is being tested?
- Functional Literacy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe behavioral management disorder that would make cooperation and direction following problematic
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
The purpose of this study is to assess a functional literacy program for formerly homeless adults now residing in supported housing who have difficulty performing daily life skills requiring functional literacy (e.g., bill paying, medication management, community transportation) needed to maintain housing placements. The hypothesis is that intervention group participants will improve in functional literacy compared to the control group that does not receive the intervention.
Read the 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.
- Conditions
- Literacy
- Being tested
- Functional Literacy Program, Usual Care Management Services
- Keywords
- functional literacy, homelessness, daily life activities
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Literacy ProgramBehavioural
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.
Usual Care Management ServicesBehavioural
The control group will receive the usual housing services without additional intervention.
| Study group | Role | What they receive |
|---|---|---|
| Functional Literacy Intervention | Experimental | 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. Receives: Behavioral: Functional Literacy Program; Behavioral: Usual Care Management Services |
| Functional Literacy Control | Active comparator | The control group will not receive intervention but the Usual Care Management Services. Receives: Behavioral: Usual Care Management Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM) score
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.
Measured: 1-week post-intervention
Secondary outcomes (1)
Inventory of Reading Occupations (IRO) score
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.
Measured: 1-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start24 Sep 2018
- Primary completion20 Nov 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 10 participants will be randomly assigned to an intervention group; another 10 will be randomly assigned to a control group.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Gutman, Columbia University
- Investigators
- Sharon Gutman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580915
- Sponsor's protocol ID
- AAAR8206
- Status last verified
- Jan 2019
- First submitted
- 25 Jun 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Functional Literacy Program for Formerly Homeless Adults
- ClinicalTrials.gov ID
- NCT03580915
- Acronym / sponsor ID
- AAAR8206
- Conditions
- Literacy
- Keywords
- functional literacy, homelessness, daily life activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess a functional literacy program for formerly homeless adults now residing in supported housing who have difficulty performing daily life skills requiring functional literacy (e.g., bill paying, medication management, community transportation) needed to maintain housing placements. The hypothesis is that intervention group participants will improve in functional literacy compared to the control group that does not receive the intervention.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 10 participants will be randomly assigned to an intervention group; another 10 will be randomly assigned to a control group.
| Arm | Type | Receives |
|---|---|---|
| Functional Literacy Intervention | Experimental | Behavioral: Functional Literacy Program, Behavioral: Usual Care Management ServicesThe 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. |
| Functional Literacy Control | Active comparator | Behavioral: Usual Care Management ServicesThe control group will not receive intervention but the Usual Care Management Services. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Severe behavioral management disorder that would make cooperation and direction following problematic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Literacy ProgramThe 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. | Behavioural | Functional Literacy Intervention |
| Usual Care Management ServicesThe control group will receive the usual housing services without additional intervention. | Behavioural | Functional Literacy Control, Functional Literacy Intervention |
Primary outcome
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.
1 secondary outcome
Inventory of Reading Occupations (IRO) score
Time frame: 1-week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Literacy
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Gutman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Literacy Program in people with Literacy, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) score (time frame: 1-week post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.