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

Not Applicable

Recruiting

• Conditions: Psychotic Disorders; Prodromal Symptoms; Psychosis; Prodromal Schizophrenia; Family
• Interventions: Behavioral: Enhanced Care (EC); Behavioral: Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)

• Registration Number: NCT04338152
• Lead Sponsor: University of California, Los Angeles

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)

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.

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-08
• Study Start: 2021-01-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Care	Enhanced Care (EC)	Enhanced Care Psychoeducation for Clinical High-Risk Individuals
FFT-CHR	Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)	Family-Focused Therapy for Clinical High-Risk Individuals

Primary Outcome Measures

Name	Time	Method
The Structured Interview for Psychosis-risk Syndromes Scale of Prodromal Symptoms (SOPS)	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 Outcome Measures

Name	Time	Method
Perceived Criticism Scale	0, 6, 12, and 18 months	Measures adolescent perceived criticism from parent(s) during treatment (highest sum score for two items rated 1-10 each, with higher scores indicating more perceived criticism), as well as parental self-rated criticism of their child (highest sum score for either parent for the 2 items rated 1-10)
The Alcohol and Drug Use Scale	0, 6, 12, and 18 months	Independent evaluator rating of frequency of use and level of impairment from alcohol and substance use in the recent month, based on combined youth and parent reports. Higher scores indicate more substance or alcohol use.
Family Interactional Assessment Task	0 and 6 months	Measures proportion of constructive vs. conflictual parent/offspring and offspring/parent communication. Scores are derived from a 10-minute live interaction sample and transcript, with each speaking turn rated on communication dimensions. Proportional scores range from 0 - 1.0, with higher scores indicating a greater proportion of conflictual (or constructive) communication
Calgary Depression Scale for Schizophrenia	0, 6, 12, and 18 months	Depression severity score based on 9-item evaluator interview (0-3 severity scores for each item). Combined total depression score, where higher scores indicate more depression.
Appraisal of Family Interactions	0, 6, 12, and 18 months	Perceived frequency of constructive/calm and critical/conflictual interactions in each parent/offspring pairing. Sum of 5 items (1-10 scales) filled out by parent(s)/youth about the frequency of critical-conflictual and calm-constructive interactions and the level of distress experienced in these interactions, with higher scores indicating more of the behavior (conflict, constructive communication or distress)
Global Functioning: Social Scale; Global Functioning: Role Scale	0, 6, 12, and 18 months	Independent evaluator rated social functioning and school/job functioning scales based on set interview questions and assessment data. Both scales capture level of functioning for the recent month, rated from 1-10, with higher scores indicating better functioning.
Global Assessment of Functioning Scale from the Structured Interview for Psychosis-risk Syndromes	0, 6, 12, and 18 months	Independent evaluator rating of combined symptom and psychosocial functioning. 1-100 point scale captures current functioning and highest/lowest functioning since previous assessment point. Higher scores indicate better functioning.

Trial Locations

Locations (7)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

University of California, San Francisco School of Medicine; 🇺🇸 San Francisco, California, United States

Harvard University/Beth Israel Deconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Zucker Hillside Hospital; 🇺🇸 New York, New York, United States

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Yale University; 🇺🇸 New Haven, Connecticut, United States