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Family Engagement Intervention for Psychosis in Adolescents

Phase 1

Recruiting

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline myts scores at 3-month follow-up

Awards & highlights

Study Summary

This trial looks at a new way to help teens with early signs of psychosis, by teaching them and their families about mental health and engaging them in outpatient care.

Eligible Conditions

Psychosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 3-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

family partnership

mental health literacy

treatment attitudes

Secondary outcome measures

enrollment in CHR monitoring/case management program

outpatient service use

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Brief intervention groupExperimental Treatment1 Intervention

TAU + experimental intervention. The experimental group will receive all services provided to the TAU group (described above) and, additionally, the experimental intervention.The intervention includes 1 individual session for each teen and parent and 2 family sessions (focused on psychoeducation and motivational enhancement) with both the teen and parent, delivered during hospitalization (~45-60 minutes per session).

Group II: TAU comparison groupActive Control1 Intervention

TAU includes standard care modules (psychoeducation, coping, safety planning, problem solving, healthy lifestyle) administered to the teen while they are hospitalized on the inpatient unit. All teens, as part of TAU, also receive skills groups, individual treatment, and family planning meetings. All TAU families will receive a referral to an outpatient provider (standard care procedure) plus referral to specialized CHR case management services.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

71,654 Total Patients Enrolled

Media Library

Treatment as usual (TAU) Clinical Trial Eligibility Overview. Trial Name: NCT04314635 — Phase 1

Psychosis Research Study Groups: TAU comparison group, Brief intervention group

Psychosis Clinical Trial 2023: Treatment as usual (TAU) Highlights & Side Effects. Trial Name: NCT04314635 — Phase 1

Treatment as usual (TAU) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04314635 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to participate in this clinical trial?

"This clinical trial stipulates that adolescents between 13 and 18 years old with mental health conditions may enrol. The study is slated to accept 80 applicants in total."

Answered by AI

What is the aggregate count of participants in this research endeavor?

"Affirmative. The data on clinicaltrials.gov states that this medical experiment, initially posted on June 29th 2020, is actively recruiting subjects. Currently there are 80 participants being sought from a single research facility."

Answered by AI

Are there any openings in this trial for new participants?

"This clinical trial, which was initially announced on June 29th 2020 and updated for the last time on October 5th 2022, is currently recruiting patients as stated by clinicaltrials.gov."

Answered by AI

Does Brief family engagement intervention for CHR have any adverse impacts on its users?

"A preliminary assessment of the family engagement intervention for CHR suggests a relative safety score of 1 out of 3; this is due to its status as Phase 1 trial, indicating restricted evidence supporting efficacy and safety."

Answered by AI

Is the age range for this research inclusive of seniors aged 85 and older?

"Applicants aged 13 to 18 are eligible for this specific clinical trial. According to the database, there is a total of 111 trials specifically catered towards minors and 257 studies tailored toward seniors over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Treatment Engagement Protocol for Psychiatrically Hospitalized Adolescents at Clinical High Risk for Psychosis

Elizabeth Thompson 2020. "A Treatment Engagement Protocol for Psychiatrically Hospitalized Adolescents at Clinical High Risk for Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04314635.