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

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2023 · $922,276

## Abstract

Project Summary
 This proposal responds to RFA-MH-18-707, “Confirmatory Efficacy Clinical Trials of Non-Pharmacological
Interventions for Mental Disorders (R01).” Adolescents and young adults at clinical high risk (CHR) for psychosis,
characterized by recent onset or worsening of attenuated positive symptoms (APS), have a 16%-30% risk of
converting to a psychotic disorder in 2 years. In a prior randomized trial in the North American Prodrome
Longitudinal Study (NAPLS) network, we showed that family-focused therapy for clinical high-risk persons (FFT-
CHR) was more effective than brief family education in (a) improving family (offspring/parent) communication
and (b) reducing APS over 6 months, particularly among CHR youth with high baseline scores on a measure of
individual risk of psychosis conversion. Both treatments were associated with reductions in young people's
perceptions of criticism from parents, which in turn were associated with decreases in APS over 12 months.
These findings led us to hypothesize enhanced family communication as a mechanism of action of FFT-CHR.
FFT-CHR consists of 18 sessions in 6 months of psychoeducation, communication training, and problem-solving
skills training. In the present study conducted in 7 NAPLS sites, we will randomly assign 220 CHR individuals
(ages 13-25) and their parent(s) to FFT-CHR or a 6-month Enhanced Care (EC) treatment, consisting of 3 family
educational sessions followed by 5 months of individual support and case management. CHR individuals will be
interviewed and fill out questionnaires regarding APS (primary outcome) and social functioning (secondary)
every 6 months over 18 months. We will examine behavioral targets indicative of improved family relationships:
reductions in proportion of critical-conflictual statements and increases in proportion of calm-constructive
statements of parents and CHR offspring in laboratory family interactional assessments conducted at baseline
and end of treatment (6 months). We will also capture granular changes in targets and outcomes through remote
monitoring: CHR participants in both conditions will enroll in a newly developed mobile phone app to facilitate
weekly proband ratings of perceived criticism, appraisals of family interactions, and primary and secondary
outcomes. We hypothesize that (1) youth/young adults in FFT-CHR will show greater improvements in APS than
those in EC in 6 months; (2) improvements in parent and offspring communication by 6 months will be associated
with downstream improvements in APS and social functioning over 18 months; and improvements in parent and
offspring communication by 6 months will mediate the relationship between treatment condition and changes in
primary and secondary outcomes over 18 months. We hypothesize that individuals who are at higher baseline
risk of psychosis conversion will show more improvement in targets and primary and secondary outcomes in
FFT-CHR than EC, compared to those at lower conversion risk. T...

## Key facts

- **NIH application ID:** 10674012
- **Project number:** 5R01MH123575-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** CARRIE E BEARDEN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $922,276
- **Award type:** 5
- **Project period:** 2020-09-07 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10674012

## Citation

> US National Institutes of Health, RePORTER application 10674012, Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial (5R01MH123575-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10674012. Licensed CC0.

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