Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial

University of California, Los Angeles (UCLA)

Status: Active, not recruiting

Conditions: Psychotic Disorders; Prodromal Symptoms; Psychosis; Family; Prodromal Schizophrenia

Treatments: Behavioral: Enhanced Care (EC); Behavioral: Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04338152

20-002102

1R01MH123575-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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)

1. 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.
2. 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.
3. 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

The primary clinical outcomes are prodromal positive symptom scores examined immediately after treatment (6 months) and at 18 months. Secondary outcomes are time to remission of positive symptoms and psychosocial functioning over 18 months. Temporal relationships between early changes in treatment targets and later changes in symptoms or psychosocial functioning will also be examined.

Primary Hypotheses

1. FFT-CHR (vs. EC) will be associated with greater improvement in positive symptoms by end of therapy and follow-up (6 and 18 months), and greater high-risk syndrome remission and better psychosocial functioning at 18 months
2. FFT-CHR (vs. EC) will be associated with greater improvement in family communication and problem solving at 6 months
3. FFT-CHR (vs. EC) will be associated with greater improvement in youth-perceived parental criticism at 6 months. In turn, improvements in family communication, problem-solving and youths' perceptions of criticism will be associated with downstream improvements in the youths' primary outcomes (positive symptoms) and secondary outcomes (time to remission and psychosocial functioning) over 18 months. Thus, improvements in family functioning are hypothesized to mediate the relationship between treatment condition (FFT-CHR, EC) and changes in primary and secondary outcomes in the individual with CHR syndrome.
4. CHR individuals with higher baseline risk of conversion are hypothesized to improve more on family communication over 6 months and primary and secondary outcomes over 18 months in FFT-CHR than in EC.

Enrollment: 220 estimated patients

Sex: All

Ages: 13 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Participants must be able to understand and sign an informed consent (or assent for minors) document in English;
2. 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
3. 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

1. Current or lifetime Axis 1 psychotic disorder by DSM-5 criteria
2. Impaired intellectual functioning (IQ<70)
3. Unwilling or unable to taper individual therapy to monthly by start of treatment
4. Past or current history of a clinically significant medical or central nervous system disorder that may contribute to CHR symptoms or confound assessment
5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

FFT-CHR

Experimental group

Description:

Family-Focused Therapy for Clinical High-Risk Individuals

Treatment:

Behavioral: Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)

Enhanced Care

Active Comparator group

Description:

Enhanced Care Psychoeducation for Clinical High-Risk Individuals

Treatment:

Behavioral: Enhanced Care (EC)