NCT01815398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

3.4 years

First QC Date

March 13, 2013

Last Update Submit

March 27, 2017

Conditions

Affective DisordersAnxiety DisordersAttention Deficit DisorderSubstance Abuse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Vocational outcome

    Baseline, 13, 26 sessions

Other Outcomes (1)

  • Intrinsic Motivation Inventory

    Baseline, 13, 26 sessions

Study Arms (2)

Computer skills training

ACTIVE COMPARATOR

26 sessions conducted 2-3 times a week to train in computer skills related to the workforce.

Behavioral: Computer Skills Training

Cognitive Remediation

EXPERIMENTAL

26 sessions conducted 2-3 times a week of cognitive remediation

Behavioral: Cognitive Remediation

Interventions

Cognitive RemediationBEHAVIORAL

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.

Also known as: NEAR
Cognitive Remediation
Computer Skills TrainingBEHAVIORAL

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.

Computer skills training

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • mental retardation (\<70 Intelligence Quotient; IQ) on premorbid intelligence estimate)
  • risk for suicide or violence
  • unremitted substance dependence within the past 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covenant House New York

New York, New York, 10019, United States

Location

Related Publications (1)

  • 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.

    PMID: 24958581DERIVED

MeSH Terms

Conditions

Mood DisordersAnxiety DisordersAttention Deficit Disorder with HyperactivitySubstance-Related Disorders

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Mental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alice A Medalia, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 21, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

January 1, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

US(1)