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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01815398
Other study ID # #6586
Secondary ID 1R21MH092569-01A
Status Completed
Phase N/A
First received March 13, 2013
Last updated March 27, 2017
Start date July 2012
Est. completion date January 2017

Study information

Verified date March 2017
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date January 2017
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 22 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Remediation
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.
Computer Skills Training
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.

Locations

Country Name City State
United States Covenant House New York New York City New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Intrinsic Motivation Inventory Self-reported motivation for cognitive treatment will be measured using the total score from the Intrinsic Motivation Inventory Baseline, 13, 26 sessions
Primary 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. Baseline, 13, 26 sessions
Secondary 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. Baseline, 13, 26 sessions
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