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Intensive Computerized Brain Training (ICBT) in Youth With Early Onset Psychosis (EOP)

Primary Purpose

Psychosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ICBT Program

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Early Onset Psychosis, Laptop Computer, Brain Training

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

EOP participants:

Clinical diagnosis of psychosis NOS, schizophrenia, schizoaffective, or schizophreniform disorder made by a child psychiatrist using DSM-IV criteria, confirmed by the KSADS (a semi-structured diagnostic interview) (Kaufman et al 1997)
Age 10-19 years inclusive
Guardian who is able and willing to participate in ongoing assessments and care
Ongoing psychiatric care for EOP including medication treatment (except typical antipsychotic medication treatment)

Normal control participants:

Age 10-19 years inclusive
Guardian who is able and willing to participate in initial diagnostic assessment

Exclusion Criteria

EOP participants:

Substance abuse within the month preceding treatment
Hearing impairment that precludes participation in ICBT
Visual impairment that precludes participation in ICBT
Medical condition that is likely to impair learning or consciousness such as epilepsy or narcolepsy
Lack of fluency in English language
Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time
Treatment with typical antipsychotic treatment
Wide Range Achievement Test (WRAT (Wilkinson 1993)) word reading subscale grade equivalent of 2.9 or lower.
Known history of premorbid developmental delay or learning disability
Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time

Normal control participants:

KSADS current or past diagnosis of psychiatric disorder including schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder, major depression, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, Tourette's disorder, eating disorder, borderline personality disorder, autism spectrum disorder, attention deficit disorder
Family history in first or second degree relative of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder, major depression, substance abuse, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, Tourette's disorder, eating disorder, borderline personality disorder, autism spectrum disorder
Substance use within the month preceding treatment
Psychotropic medication treatment
Hearing impairment that precludes participation in ICBT
Visual impairment that precludes participation in ICBT
Medical condition that is likely to impair learning or consciousness such as epilepsy or narcolepsy
Lack of fluency in English language
Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time
Wide Range Achievement Test (WRAT (Wilkinson 1993)) word reading subscale grade equivalent of 2.9 or lower.
Known history of premorbid developmental delay or learning disability

Sites / Locations

University of North Carolina, Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

No Intervention

Arm Label

ICBT Program

Control Intervention

Healthy Control Group

Arm Description

Intensive Computerized Brain Training using software packages donated by Posit Science.

Commercially available computer games that do not contain violent stimuli but are appealing to youth between 10 and 19 years of age.

No participation in computer activity.

Outcomes

Primary Outcome Measures

Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP.

Secondary Outcome Measures

Full Information

NCT ID

NCT01027962

First Posted

December 7, 2009

Last Updated

January 14, 2013

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Foundation of Hope, North Carolina, National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01027962

Brief Title

Intensive Computerized Brain Training (ICBT) in Youth With Early Onset Psychosis (EOP)

Official Title

Intensive Computerized Brain Training in Early Onset Psychosis-Pilot Phase

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Foundation of Hope, North Carolina, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to examine whether an intensive computerized intervention targeted on improving central auditory and visual processing and executive functioning can be implemented in youths aged 10-19 with psychotic spectrum disorders, what developmental modifications are needed particularly for the younger participants, and whether it is possible to develop an appropriate, blinded control intervention.

Detailed Description

The purpose of this study is to provide a foundation for future rigorous study of an intervention that translates what we know about refinement of synaptic connections in response to environmental stimuli to an individualized intervention that directly improves neurocognitive functioning in youths with early onset psychosis(EOP). We will conduct a pilot randomized control study that determines the feasibility, tolerability and acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP. Participants: Seventy youths, aged 10 years to 19 years inclusive will be assessed in the study. Forty youths with EOP will be randomly assigned to ICBT or an equally intense computerized game activity and 20 will be age, gender and race matched youths with no major psychiatric illnesses. We will allow for up to 5 EOP screen failures and up to 5 healthy control screen failures. Procedures (methods): The forty participants with EOP will be randomly assigned to treatment with ICBT or equally intense video game play that also involves attention to sensory stimuli and requires increasingly skilled responses. A computer generated randomization schedule will be used to make assignments. Outcomes will be assessed at baseline, completion of the intervention (typically week 20), 3 after completing the intervention (typically month 8) and 7 months after completing the intervention(typically month 12). The other 20 youths, who comprise the typically developing comparison group known as healthy controls, will not participate in the computer activity or regular monthly psychiatric visits and will not complete satisfaction questionnaires. Up to 10 subjects may not be eligible to participate in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychosis

Keywords

Early Onset Psychosis, Laptop Computer, Brain Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ICBT Program

Arm Type

Other

Arm Description

Intensive Computerized Brain Training using software packages donated by Posit Science.

Arm Title

Control Intervention

Arm Type

No Intervention

Arm Description

Commercially available computer games that do not contain violent stimuli but are appealing to youth between 10 and 19 years of age.

Arm Title

Healthy Control Group

Arm Type

No Intervention

Arm Description

No participation in computer activity.

Intervention Type

Other

Intervention Name(s)

ICBT Program

Other Intervention Name(s)

Posit Science

Intervention Description

Intensive Computerized Brain Training.

Primary Outcome Measure Information:

Title

Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: EOP participants: Clinical diagnosis of psychosis NOS, schizophrenia, schizoaffective, or schizophreniform disorder made by a child psychiatrist using DSM-IV criteria, confirmed by the KSADS (a semi-structured diagnostic interview) (Kaufman et al 1997) Age 10-19 years inclusive Guardian who is able and willing to participate in ongoing assessments and care Ongoing psychiatric care for EOP including medication treatment (except typical antipsychotic medication treatment) Normal control participants: Age 10-19 years inclusive Guardian who is able and willing to participate in initial diagnostic assessment Exclusion Criteria EOP participants: Substance abuse within the month preceding treatment Hearing impairment that precludes participation in ICBT Visual impairment that precludes participation in ICBT Medical condition that is likely to impair learning or consciousness such as epilepsy or narcolepsy Lack of fluency in English language Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time Treatment with typical antipsychotic treatment Wide Range Achievement Test (WRAT (Wilkinson 1993)) word reading subscale grade equivalent of 2.9 or lower. Known history of premorbid developmental delay or learning disability Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time Normal control participants: KSADS current or past diagnosis of psychiatric disorder including schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder, major depression, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, Tourette's disorder, eating disorder, borderline personality disorder, autism spectrum disorder, attention deficit disorder Family history in first or second degree relative of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder, major depression, substance abuse, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, Tourette's disorder, eating disorder, borderline personality disorder, autism spectrum disorder Substance use within the month preceding treatment Psychotropic medication treatment Hearing impairment that precludes participation in ICBT Visual impairment that precludes participation in ICBT Medical condition that is likely to impair learning or consciousness such as epilepsy or narcolepsy Lack of fluency in English language Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time Wide Range Achievement Test (WRAT (Wilkinson 1993)) word reading subscale grade equivalent of 2.9 or lower. Known history of premorbid developmental delay or learning disability

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lin Sikich, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ann Maloney, MD

Organizational Affiliation

MaineHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina, Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

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Intensive Computerized Brain Training (ICBT) in Youth With Early Onset Psychosis (EOP)

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