Affective DisordersNCT01815398
Cognitive Skills Training for Homeless Youth
A study testing Cognitive Remediation and Computer Skills Training in people with Affective Disorders and Anxiety Disorders, run by New York State Psychiatric Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 22 years
- Conditions the study is for
- Affective Disorders, Anxiety Disorders, Attention Deficit Disorder
- What is being tested?
- Cognitive Remediation and Computer Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jan 2017
- 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 22 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- mental retardation (<70 Intelligence Quotient; IQ) on premorbid intelligence estimate)
- risk for suicide or violence
- unremitted substance dependence within the past 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Skills Training to Improve Vocational Outcome in Homeless Youth
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.
Read the 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.
- Being tested
- Cognitive Remediation, Computer Skills Training
- Medical subject headings
- Mood Disorders, Anxiety Disorders, Attention Deficit Disorder with Hyperactivity, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationBehavioural
Also called NEAR
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Computer skills training | Active comparator | 26 sessions conducted 2-3 times a week to train in computer skills related to the workforce. Receives: Behavioral: Computer Skills Training |
| Cognitive Remediation | Experimental | 26 sessions conducted 2-3 times a week of cognitive remediation Receives: Behavioral: Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 13, 26 sessions
Secondary outcomes (1)
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.
Measured: Baseline, 13, 26 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Affective DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Alice A Medalia, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815398
- Sponsor's protocol ID
- #6586
- Other IDs
- 1R21MH092569-01A1
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2013
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24958581
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Skills Training to Improve Vocational Outcome in Homeless Youth
- ClinicalTrials.gov ID
- NCT01815398
- Acronym / sponsor ID
- #6586
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Mar 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer skills training | Active comparator | Behavioral: Computer Skills Training26 sessions conducted 2-3 times a week to train in computer skills related to the workforce. |
| Cognitive Remediation | Experimental | Behavioral: Cognitive Remediation26 sessions conducted 2-3 times a week of cognitive remediation |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- mental retardation (<70 Intelligence Quotient; IQ) on premorbid intelligence estimate)
- risk for suicide or violence
- unremitted substance dependence within the past 6 weeks
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 |
|---|---|---|
| Cognitive RemediationAlso: NEARNeuropsychological 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. | Behavioural | Cognitive Remediation |
| Computer Skills TrainingParticipants 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. | Behavioural | Computer skills training |
Primary outcome
Global Cognition Score
Time frame: Baseline, 13, 26 sessions
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.
1 secondary outcome
Vocational outcome
Time frame: Baseline, 13, 26 sessions
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 28 Mar 2017.
- Derived from this study: PubMed 24958581Saperstein 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.
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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.
Alice A Medalia, PhD 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 Cognitive Remediation and Computer Skills Training in people with Affective Disorders and Anxiety Disorders, run by New York State Psychiatric Institute 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 4 inclusion and 3 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 28 Mar 2017. 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?
Global Cognition Score (time frame: Baseline, 13, 26 sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01815398, which also lists 1 linked publication.
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 28 Mar 2017.