Cognitive Skills Training for Homeless Youth
Primary Purpose
Affective Disorders, Anxiety Disorders, Attention Deficit Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation
Computer Skills Training
Sponsored by
About this trial
This is an interventional treatment trial for Affective Disorders
Eligibility Criteria
Inclusion Criteria:
- have a current Diagnostic and Statistical Manual (DSM-IV) Axis I diagnosis
- residing at Covenant House New York Rights of Passage Program
- psychiatrically stable for at least 21 days
- English speaking
Exclusion Criteria:
- mental retardation (<70 Intelligence Quotient; IQ) on premorbid intelligence estimate)
- risk for suicide or violence
- unremitted substance dependence within the past 6 weeks
Sites / Locations
- Covenant House New York
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Computer skills training
Cognitive Remediation
Arm Description
26 sessions conducted 2-3 times a week to train in computer skills related to the workforce.
26 sessions conducted 2-3 times a week of cognitive remediation
Outcomes
Primary Outcome Measures
Global Cognition Score
A Global Cognition Score will be derived from the average z scores in five domains of cognitive functioning: working memory, verbal memory, processing speed, executive functioning, and attention.
Secondary Outcome Measures
Vocational outcome
The vocational outcome will be total number of hours worked. Hours worked per week (range of 0 to 40) will be summed from the time of session 1 of cognitive remediation/active control to the time of one month followup.
Full Information
NCT ID
NCT01815398
First Posted
March 13, 2013
Last Updated
March 27, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01815398
Brief Title
Cognitive Skills Training for Homeless Youth
Official Title
Cognitive Skills Training to Improve Vocational Outcome in Homeless Youth
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many young people who are homeless have cognitive deficits which impede their ability to secure and maintain employment. This study looks to see if targeting cognitive deficits can improve cognition and vocational outcome.
Detailed Description
The aim of this research is to conduct a controlled study of cognitive remediation, to provide feasibility data on adapting an established empirically-based cognitive intervention for homeless youth to help them attain vocational goals. The ultimate purpose is that youth will improve in cognitive functioning and have better functional outcomes including jobs to sustain independent living.
The results of this study will inform a larger trial on the efficacy of cognitive remediation in homeless youth to improve cognition and vocational outcomes. Hypotheses are that, compared to those in an active control group receiving computerized work-skills training, individuals who receive cognitive remediation will show greater cognitive benefits on proximal measures of neurocognition and evidence better vocational outcome as defined by greater number of hours worked. This study will address the service gap in the use of integrated psychosocial interventions for homeless populations as the first investigation of cognitive remediation in homeless youth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Affective Disorders, Anxiety Disorders, Attention Deficit Disorder, Substance Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer skills training
Arm Type
Active Comparator
Arm Description
26 sessions conducted 2-3 times a week to train in computer skills related to the workforce.
Arm Title
Cognitive Remediation
Arm Type
Experimental
Arm Description
26 sessions conducted 2-3 times a week of cognitive remediation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Other Intervention Name(s)
NEAR
Intervention Description
Neuropsychological Educational Approach to Remediation (NEAR) is an evidence based, manualized cognitive remediation program that targets cognitive deficits (eg memory, processing speed, executive functioning, working memory and attention) with the intent of improving daily functioning.NEAR is conducted in a small group setting, allowing for supportive social interaction while participants work at their own computer station on engaging computerized activities that are selected to address their unique profile of cognitive deficits. Then, as a group they discuss how their respective cognitive activities will help them achieve their vocational goals.
Intervention Type
Behavioral
Intervention Name(s)
Computer Skills Training
Intervention Description
Participants utilize an interactive software program that delivers tutorials, lessons, and practice sessions to develop computer skills for office based employment. During the learning activities, the clinician offers coaching and assistance in setting up computerized training exercises as needed.
Primary Outcome Measure Information:
Title
Global Cognition Score
Description
A Global Cognition Score will be derived from the average z scores in five domains of cognitive functioning: working memory, verbal memory, processing speed, executive functioning, and attention.
Time Frame
Baseline, 13, 26 sessions
Secondary Outcome Measure Information:
Title
Vocational outcome
Description
The vocational outcome will be total number of hours worked. Hours worked per week (range of 0 to 40) will be summed from the time of session 1 of cognitive remediation/active control to the time of one month followup.
Time Frame
Baseline, 13, 26 sessions
Other Pre-specified Outcome Measures:
Title
Intrinsic Motivation Inventory
Description
Self-reported motivation for cognitive treatment will be measured using the total score from the Intrinsic Motivation Inventory
Time Frame
Baseline, 13, 26 sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
have a current Diagnostic and Statistical Manual (DSM-IV) Axis I diagnosis
residing at Covenant House New York Rights of Passage Program
psychiatrically stable for at least 21 days
English speaking
Exclusion Criteria:
mental retardation (<70 Intelligence Quotient; IQ) on premorbid intelligence estimate)
risk for suicide or violence
unremitted substance dependence within the past 6 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice A Medalia, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covenant House New York
City
New York City
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24958581
Citation
Saperstein AM, Lee S, Ronan EJ, Seeman RS, Medalia A. Cognitive deficit and mental health in homeless transition-age youth. Pediatrics. 2014 Jul;134(1):e138-45. doi: 10.1542/peds.2013-4302.
Results Reference
derived
Learn more about this trial
Cognitive Skills Training for Homeless Youth
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