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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Harvard University | OTHER |
| University of California, Irvine | OTHER |
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The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). The goal of the treatment is prevention of psychosis and disability. This study will assess experimentally the clinical effectiveness of this new type of mental health service. Other domains of outcome include cognitive dysfunction and functional disability.
The proposed study will be part of a larger program, Portland Identification and Early Referral (PIER), under foundation, NIH and Center for Mental Health Services sponsorship, that has established a population-based system of early detection for Greater Portland, Maine. Previous and present effort has educated and trained the community-at-large and all health, education and other professionals, with the result that referrals are occurring at the expected frequency. The principal strategy is to intervene early, prior to onset, in the course of the onset of psychotic disorders to arrest the development of psychotic symptoms and functional disability. The test treatment is a specialized combination of psychoeducational multifamily group and assertive community treatment.
The project will support a team of clinical staff with the ability to: a. foster detection of prodromal disorders in the Greater Portland community by general practitioners, guidance counselors, mental health professionals and the general public; b. accurately assess individuals at high risk for psychosis; c. reliably deliver an evidence-based psychosocial and, if indicated, pharmacological treatment package using standardized methodology. The research study will test, in a randomized controlled trial, the symptomatic and functional outcome of treatment in 100 subjects ages 12 to 35 identified by that system. It will allow the analysis of key social factors contributing to psychosis and their interaction with the treatment conditions and each other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-aided Assertive Community Treatment | Experimental | The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. |
|
| Enhanced standard treatment | Active Comparator | In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-aided Assertive Community Treatment | Behavioral | The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Psychosis | Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults. | From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functioning | Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William R McFarlane, M.D. | MaineHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24632857 | Background | McFarlane WR, Susser E, McCleary R, Verdi M, Lynch S, Williams D, McKeague IW. Reduction in incidence of hospitalizations for psychotic episodes through early identification and intervention. Psychiatr Serv. 2014 Oct;65(10):1194-200. doi: 10.1176/appi.ps.201300336. | |
| 23434505 | Background | Woodberry KA, McFarlane WR, Giuliano AJ, Verdi MB, Cook WL, Faraone SV, Seidman LJ. Change in neuropsychological functioning over one year in youth at clinical high risk for psychosis. Schizophr Res. 2013 May;146(1-3):87-94. doi: 10.1016/j.schres.2013.01.017. Epub 2013 Feb 22. |
| Label | URL |
|---|---|
| Describes risk factors for psychosis, current scientific understanding of psychosis and means of accessing services | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Family-aided ACT | The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. |
| FG001 | Enhanced Treatment | In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Family-aided ACT | The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Onset of Psychosis | Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults. | Posted | Number | percentage of sample converting | From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Family-aided Assertive Community Treatment | The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William R. McFarlane, M.D. | Maine Medical Center Research Institute | 207-662-4348 | mcfarw@mmc.org |
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| ID | Term |
|---|---|
| D012569 | Schizotypal Personality Disorder |
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| Enhanced standard treatment | Behavioral | In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention |
|
| 20439374 | Result | McFarlane WR, Cook WL, Downing D, Verdi MB, Woodberry KA, Ruff A. Portland identification and early referral: a community-based system for identifying and treating youths at high risk of psychosis. Psychiatr Serv. 2010 May;61(5):512-5. doi: 10.1176/appi.ps.61.5.512. |
| BG001 | Enhanced Treatment | In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Global Assessment of Functioning (GAF) | The Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning and 0 the 3 lowest. | Mean | Standard Deviation | units on GAF scale |
|
| OG001 | Enhanced Treatment | In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention |
|
|
| Secondary | Functioning | Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning. | 15 participants in the FACT arm and 16 participants in the Enhanced Standard Treatment arm were not assessed, having discontinued participation in the study. | Posted | Mean | Standard Deviation | units on GAF scale | 24 months |
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|
|
| 1 |
| 50 |
| 0 |
| 50 |
| EG001 | Enhanced Standard Treatment | In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. | 1 | 50 | 0 | 50 |
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