NCT01907282

Brief Summary

Preventing psychotic disorders such as schizophrenia and associated functional disability could relieve an enormous burden of personal and family suffering and economic losses to society. This project aims to conduct a pilot randomized trial to determine the efficacy of a family-focused treatment in comparison with treatment-as-usual in enhancing functional outcomes, stabilizing symptoms, and preventing or delaying the onset of full psychosis in transitional age youth with prodromal symptoms. The results of this study will be crucial for the development of cost-effective, evidence-based psychosocial approaches to psychosis prevention and thus will have major implications for public health.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

3 years

First QC Date

July 16, 2013

Last Update Submit

July 18, 2013

Conditions

Psychosis

Keywords

Schizophreniapsychosis

Outcome Measures

Primary Outcomes (1)

  • Change in subthreshold psychotic (positive and negative) symptoms

    Participants are rated for the 3 months prior to random assignment and again at 6 and 12 months on the Structured Interview for Prodromal Symptoms (SIPS), from which attenuated psychotic (positive and negative) symptoms are rated.

    Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment

Secondary Outcomes (2)

  • Conversion to psychosis

    Onset of a fully syndromal period of psychosis during the 12 month study

  • Changes in psychosocial Functioning

    Change from pretreatment (1 month prior to randomization) to 12 months

Other Outcomes (1)

  • Changes in family interactional behavior

    Change from baseline (beginning of psychosocial treatment) to 6 month reassessment

Study Arms (2)

Family Focused Treatment

EXPERIMENTAL

Family-Focused Treatment (FFT) consists of 18 sessions of psychoeducation, communication enhancement training, and problem-solving skills training in six months

Behavioral: Family Focused Treatment

Enhanced Care

ACTIVE COMPARATOR

Enhanced care is a 3-session family psychoeducational therapy focused on prevention of psychotic symptoms

Behavioral: Enhanced Care

Interventions

Family Focused TreatmentBEHAVIORAL

Treatment for family that focuses on skills for coping with subthreshold positive and negative symptoms and improving family communication and problem-solving

Also known as: Family Therapy, Family Psychoeducation, Behavioral Family Therapy
Family Focused Treatment
Enhanced CareBEHAVIORAL

This 3-session psychoeducational treatment assists individuals and families in coping with early warning signs of psychotic episodes.

Also known as: Brief psychoeducation
Enhanced Care

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 12 years, 0 months and 35 years, 11 months
  • Speaks and writes English
  • Availability of at least one family member for treatment
  • Meets criteria for one of three prodromal syndromes as assessed by the
  • Structured Interview for Prodromal Syndromes:
  • attenuated positive symptoms that are sub-psychotic in duration and intensity and have begun or worsened in the past year;
  • brief intermittent psychosis, defined as or syndromal psychotic symptoms that are have been present intermittently with onset in the previous 3 months; or
  • genetic risk and deterioration, defined as a diagnosis of schizotypal personality disorder or having a first degree relative with a psychotic disorder, plus having experienced a substantial decline (30% or greater) in Global Assessment of Functioning scores in the last year.

You may not qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Pervasive developmental disorders
  • Current substance or alcohol dependence
  • Neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCLA School of Medicine

Los Angeles, California, 90025, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Harvard University/Beth Israel Deconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Zucker Hillside Hospital

New York, New York, 11004, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Calgary

Calgary, Alberta, Canada

Location

Related Publications (2)

  • Schlosser DA, Miklowitz DJ, O'Brien MP, De Silva SD, Zinberg JL, Cannon TD. A randomized trial of family focused treatment for adolescents and young adults at risk for psychosis: study rationale, design and methods. Early Interv Psychiatry. 2012 Aug;6(3):283-91. doi: 10.1111/j.1751-7893.2011.00317.x. Epub 2011 Dec 20.

    PMID: 22182667BACKGROUND

  • Miklowitz DJ, O'Brien MP, Schlosser DA, Addington J, Candan KA, Marshall C, Domingues I, Walsh BC, Zinberg JL, De Silva SD, Friedman-Yakoobian M, Cannon TD. Family-focused treatment for adolescents and young adults at high risk for psychosis: results of a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):848-58. doi: 10.1016/j.jaac.2014.04.020. Epub 2014 Jun 2.

    PMID: 25062592DERIVED

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

Family Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • David J Miklowitz, PhD

    UCLA Semel Institute

    PRINCIPAL INVESTIGATOR

  • Tyrone Cannon, Ph.D.

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 24, 2013

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

US(7)CA(1)