Prevention Trial of Family Focused Treatment in Youth at Risk for Psychosis
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

Detailed description: 
      The goal of this research is to conduct a multisite randomized trial to determine the
      efficacy of a 6-month Family-Focused Treatment (FFT) in comparison with Enhanced Care (EC), a
      treatment-as-usual intervention, in reducing symptoms, enhancing functional outcomes, and
      preventing or delaying the onset of full psychosis in youth aged 12-35 years who meet
      criteria for a prodromal risk syndrome according to the Structured Interview for Prodromal
      Syndromes (SIPS). Our primary, secondary, and tertiary hypotheses, respectively, are that
      at-risk probands will respond better to FFT than EC at 6- and 12-month follow-ups, in terms
      of symptom trajectories (SIPS scores), social/family functioning, and first onset of full
      psychosis. Subjects will be drawn from the participants in a prospective, longitudinal study
      elucidating predictors and mechanisms of conversion to psychosis (North American Prodrome
      Longitudinal Study, or NAPLS), on which the sites collaborate. Subjects will be interviewed
      every 6 months for 1 year to assess positive and negative symptoms, academic and social
      functioning, family functioning, and conversion to psychosis.

      Recent progress in risk ascertainment methodology has enabled reliable identification of
      persons with prodromal or "clinical high-risk" syndromes, 35% of whom develop psychosis
      within 2 and ½ years. This paradigm provides an opportunity for developing and testing
      interventions in the prodromal phase, before the onset of full psychosis and accumulation of
      substantial functional disability. Psychosocial interventions appear to be well suited to
      address issues of motivational deficits and functional disability in the psychosis prodrome.
      Given our present state of knowledge regarding the mechanisms of psychosis onset, and given
      that initial studies of antipsychotic drugs in prodromal patients have produced discouraging
      results in terms of prevention, a short term reduction in symptom severity and functional
      disability may represent a more achievable target than a reduction in psychosis incidence. We
      have developed and piloted a version of FFT for clinical high risk youth (FFT-CHR) consisting
      of psychoeducation, communication training, and problem-solving skills training. In
      randomized trials, adults and adolescents with bipolar disorder and children at-risk for
      bipolar disorder undergoing FFT improved symptomatically and functionally compared to
      patients in brief psychoeducational control conditions. Further, an open trial of family
      psychoeducation for youth at risk for psychosis demonstrated symptomatic and functional
      improvements relative to baseline scores. However, no randomized controlled study has
      examined the efficacy of FFT for reducing symptoms or functional disability in youth at risk
      for psychosis.

      In view of the improvements in quality of life and the reductions in costs of care that have
      occurred with preventive approaches to cardiovascular disease, diabetes, and certain forms of
      cancer, the field of psychiatry is in need of a major commitment to an early
      detection/prevention framework for its most debilitating syndromes - the psychotic disorders.
      The prodromal risk syndrome criteria have resulted in clinical algorithms that are highly
      effective in predicting onset of full psychosis. However, such knowledge will be of limited
      utility if we lack the means of intervening in the pre-onset phase in a way that either
      reduces the likelihood of progression to full psychosis, the accumulation of functional
      disability, or both. There are currently no cost-effective, evidence-based psychosocial
      approaches to psychosis prevention. Preventing the neurotoxic effects of early episodes,
      before these illnesses become chronic, and minimizing the psychosocial sequelae of early
      episodes, may do much to prevent the long-term disability caused by psychosis and thereby
      have a major impact on public health. Our study will take the critical next step by
      performing an initial efficacy test of a highly promising family-focused intervention
      designed to stabilize symptoms and improve social and role functioning in at risk youth.
    

Intervention name(s): Family Focused Treatment; Enhanced Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treatment for family that focuses on skills for coping with subthreshold positive and negative symptoms and improving family communication and problem-solving; This 3-session psychoeducational treatment assists individuals and families in coping with early warning signs of psychotic episodes.
Other intervention name(s): Family Therapy; Family Psychoeducation; Behavioral Family Therapy; Brief psychoeducation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; psychosis