Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 220
- Locations
- 7
- Primary Endpoint
- The Structured Interview for Psychosis-risk Syndromes Scale of Prodromal Symptoms (SOPS)
Study Overview
Brief Summary
The present study is a confirmatory efficacy trial of Family Focused Therapy for youth at clinical high risk for psychosis (FFT-CHR). This trial is sponsored by seven mature CHR clinical research programs from the North American Prodrome Longitudinal Study (NAPLS). The young clinical high risk sample (N = 220 youth ages 13-25) is to be followed at 6-month intervals for 18 months.
Detailed Description
This randomized, single blind trial will compare outcomes from a 6-month FFT-CHR intervention and a control condition (enhanced care, or EC) matched to the FFT-CHR in duration (6 months) and access to a clinician. Participants families in FFT-CHR are provided 18 family sessions augmented by a therapy app with content and surveys, while participants in the EC condition are provided three family sessions plus five monthly individual support and case management sessions. Duration of therapy sessions is one hour.
Main Goals of FFT-CHR (Experimental Treatment)
- To assist young clients and their family in: developing a common understanding of CHR symptoms; recognizing early signs of escalating symptoms; practicing individual and family coping strategies; and pre-planning family responses to any escalation in symptoms. When families have poor understanding of CHR symptoms and strategies for their management, this can fuel stressful home dynamics and contribute to youth withdrawal and decompensation.
- For the youth and their family members to learn to express more constructive messages during their interactions, particularly regarding highly charged topics such as curbing risky behaviors and management of the offspring's symptoms.
- For youth and family members to practice skills for resolving family or extrafamilial conflicts (usually those related to the youth's functioning) through effective communication and problem solving
The control condition, Enhanced Care (EC) shares the psychoeducation goal of FFT-CHR but is more oriented toward skill-training for the individual patient. Whereas it does not offer the same level of opportunity for families to build communication and problem-solving skills, the family is actively involved in helping the individual develop a relapse prevention plan. Monthly individual sessions focus on the development of individual coping skills such as symptom tracking and problem-solving. Both conditions require families to submit real-time mobile app surveys to assist with progress tracking.
Study Aims
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 13 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must be able to understand and sign an informed consent (or assent for minors) document in English;
- •Youth has at least one parent or legal guardian who participants sees often enough (minimum 4 hours/week) that family intervention is sensible, who is English-speaking, and who consents to study participation and treatment sessions; and
- •Youth currently meets criteria for clinical high-risk (CHR) for psychosis, with attenuated positive symptoms that have begun or worsened in the past 12 months, genetic risk and deterioration, or brief intermittent psychotic symptoms. Eligible participants may meet DSM-5 criteria for any non-psychotic disorder (e.g. major depression, anxiety disorders, ADHD), as long as the disorder does not clearly account for the presence of psychosis risk symptoms.
Exclusion Criteria
- •Current or lifetime Axis 1 psychotic disorder by DSM-5 criteria
- •Impaired intellectual functioning (IQ<70)
- •Unwilling or unable to taper individual therapy to monthly by start of treatment
- •Past or current history of a clinically significant medical or central nervous system disorder that may contribute to CHR symptoms or confound assessment
- •Severe substance or alcohol use disorder within the past 6 months, and/or substance use (including cannabis) is causally related to recent onset of CHR symptoms so as to confound prodromal diagnostic determination.
- •If either an exclusionary medical condition or an incidental medical condition is suspected, the participant will be advised to consult with their physician or will be referred to a specialist. Eligibility for the trial will be reconsidered if the medical condition has been treated to remission and the subject still meets CHR criteria.
Arms & Interventions
FFT-CHR
Family-Focused Therapy for Clinical High-Risk Individuals
Intervention: Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) (Behavioral)
Enhanced Care
Enhanced Care Psychoeducation for Clinical High-Risk Individuals
Intervention: Enhanced Care (EC) (Behavioral)
Outcomes
Primary Outcomes
The Structured Interview for Psychosis-risk Syndromes Scale of Prodromal Symptoms (SOPS)
Time Frame: 0, 6, 12, and 18 months
The change from baseline to follow-up in Total Scale of Prodromal Symptoms (SOPS) Positive scores (sum of items 1 to 5) will be significantly greater in clinical high-risk patients assigned to FFT-CHR vs. EC. Total SOPS scores range from 0-30, with higher scores indicating more severe symptoms. In FFT-CHR (versus EC), rates of remission of prodromal symptoms will be higher and rates of conversion to psychosis will be lower over 18 months.
Secondary Outcomes
- Perceived Criticism Scale(0, 6, 12, and 18 months)
- The Alcohol and Drug Use Scale(0, 6, 12, and 18 months)
- Family Interactional Assessment Task(0 and 6 months)
- Calgary Depression Scale for Schizophrenia(0, 6, 12, and 18 months)
- Appraisal of Family Interactions(0, 6, 12, and 18 months)
- Global Functioning: Social Scale; Global Functioning: Role Scale(0, 6, 12, and 18 months)
- Global Assessment of Functioning Scale from the Structured Interview for Psychosis-risk Syndromes(0, 6, 12, and 18 months)
Investigators
David J. Miklowitz, Ph.D.
Principal Investigator
University of California, Los Angeles