Intensive Computerized Brain Training in Early Onset Psychosis-Pilot Phase
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Psychosis
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Linmarie Sikich, MD
Associate Professor
University of North Carolina, Chapel Hill
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:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP.
Time Frame: 2 years