Active not recruitingNAINTERVENTIONAL

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

This study is testing a family therapy called 'Family-Focused Therapy for Clinical High Risk Youth' (FFT-CHR) for young people aged 13-25 who are at high risk of developing psychosis. It's a new way to help families understand symptoms, improve how they talk to each other, and learn coping skills together. The research involves 220 young people and their families and is conducted by several groups across North America. Participants will either receive the FFT-CHR therapy for six months, which includes family sessions and an app, or an ‘enhanced care’ program that focuses more on individual support. The aim is to see if FFT-CHR can help families avoid stressful situations and better manage any difficulties related to the symptoms, over an 18-month period.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of California, Los Angeles

Enrolment target

220

Start

15 Jan 2021

Estimated completion

31 Dec 2026

Psychotic Disorders Prodromal Symptoms Prodromal Schizophrenia Psychosis Family

What is this study about?

This research study is looking into a special type of family therapy designed for young people aged 13 to 25 who are thought to be at a high risk of developing conditions like psychosis. Psychosis is a serious mental health problem where a person might experience confused thoughts or have difficulty knowing what's real. The therapy, called Family-Focused Therapy for Clinical High Risk Youth (FFT-CHR), aims to help these young people and their families understand the early signs, learn how to cope, and communicate better.

The study wants to see how well this family therapy works compared to a standard support program. The main idea is that if families can learn to understand symptoms, talk more openly, and work together to solve problems, it might help prevent a stressful home environment and reduce the chances of the young person's symptoms getting worse. The therapy encourages families to recognise early warning signs and have a plan for how to respond if symptoms escalate.

Over 200 young people and their families will take part. Some will receive the FFT-CHR therapy, which involves 18 family sessions and a helpful app. Others will receive an 'enhanced care' program, which includes some family sessions and individual support for the young person. This research is important because it could show a helpful new way to support young people and their families during a challenging time, focusing on improving family life and mental well-being.

Key takeaways

This study evaluates family therapy for young people at high risk of psychosis.
It aims to improve family understanding, communication, and coping skills.
Participation involves either family therapy or enhanced individual and family support.
The study lasts 18 months, with a 6-month therapy phase.
It's for young people aged 13-25 and their families.
No medication is involved, only therapy and support.

Who may be eligible?

This study is for young people between 13 and 25 years old who are considered to be at a high risk of developing psychosis. You must also have at least one parent or guardian who can take part in the study with you, speaks English, and sees you regularly (at least four hours a week). You must be able to understand and agree to take part in the study, or have a parent or guardian give permission if you're under 16.

You would not be able to join if you have already been diagnosed with a psychotic disorder, have a learning disability (like an IQ below 70), or have a serious ongoing medical condition that might be causing your symptoms. People with a severe problem with drugs or alcohol in the last six months would also not be able to join, especially if substance use seems to be the main cause of the symptoms. If you already have a lot of other therapy, you might need to adjust it to monthly sessions to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 13 and 25 years old?
Do you have a parent or guardian who speaks English and sees you often (at least 4 hours/week) who can join you?
Have you started to show some early signs of psychosis in the last 12 months, but haven't been diagnosed with psychosis?
Do you not have a serious learning disability (like an IQ below 70)?
Have you not had a severe substance or alcohol problem in the last 6 months that causes your symptoms?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be randomly assigned to one of two groups. One group will receive 'Family-Focused Therapy for Clinical High Risk Youth' (FFT-CHR) for six months. This involves 18 hour-long family sessions and using a therapy app with content and surveys. The other group will receive 'Enhanced Care' for six months. This includes three family sessions and five monthly individual support and case management sessions, each lasting one hour. Both groups require families to regularly share updates in real-time.

You and your family will be followed for a total of 18 months, with check-ups every six months. This means you will have appointments and assessments at the start of the study, after six months, after 12 months, and at the 18-month mark. There are no study medications involved; it's all about therapy and support.

Potential risks and benefits

Taking part in this study could potentially offer benefits such as gaining a better understanding of your symptoms, improving communication within your family, and learning new ways to cope with challenges. You might also find the support from the therapists helpful. As with any study involving therapy, there's always a chance that discussing sensitive topics might be emotionally challenging at times. Information about you will be kept private. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

University of California, Los Angeles
Verified postcode
Los Angeles, United States
University of California, San Diego
Verified postcode
San Diego, United States
University of California, San Francisco School of Medicine
Verified postcode
San Francisco, United States
Yale University
Verified postcode
New Haven, United States
Harvard University/Beth Israel Deconess Medical Center
Verified postcode
Boston, United States
Zucker Hillside Hospital
Verified postcode
New York, United States
University of Calgary
Verified postcode
Calgary, Canada

Common questions

What is 'high risk for psychosis'?

It means a young person shows some early warning signs or symptoms that suggest they might be more likely to develop psychosis in the future, but they haven't been diagnosed with it yet.

What is 'Family-Focused Therapy'?

It's a type of therapy where the whole family works together with a therapist to understand challenges, improve how they talk to each other, and learn ways to cope with symptoms.

Will I have to take any medication?

No, this study is about different types of therapy and support programs, not medication.

How long will I be involved in the study?

You'll receive therapy for 6 months, and then you'll be followed up for a total of 18 months.

What if I feel uncomfortable during the study?

You have the right to withdraw from the study at any time, for any reason, and it won't affect your medical care.