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

Official Title: “Intensive Computerized Brain Training in Early Onset Psychosis-Pilot Phase”

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.

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: Sixty 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.

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.

Intervention(s) in this Clinical Trial

• Other: ICBT Program
  • Intensive Computerized Brain Training.

Arms, Groups and Cohorts in this Clinical Trial

• Other: ICBT Program
  • Intensive Computerized Brain Training using software packages donated by Posit Science.
• No Intervention: Control Intervention
  • Commercially available computer games that do not contain violent stimuli but are appealing to youth between 10 and 19 years of age.
• No Intervention: Healthy Control Group
  • No participation in computer activity.

Primary Measures

• Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP.
  • Time Frame: 2 years
    Safety Issue?: No

Inclusion Criteria:

EOP participants:

• Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or Psychosis NOS 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 19 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of North Carolina, Chapel Hill Other

Overall Clinical Trial Officials and Contacts

Lin Sikich, MD Principal Investigator University of North Carolina, Chapel Hill  

Overall Contact: Niki Connelly, BA 800-708-0048 aspire@unc.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01027962

Study ID Number: UNC # 09-0637; Maine #3589

ClinicalTrials.gov Identifier: NCT01027962

Health Authority: United States: Institutional Review Board