Trial Outcomes & Findings for Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis (NCT NCT04325568)

NCT ID: NCT04325568

Last Updated: 2024-03-19

Results Overview

Asks participants to rate the likelihood that engaging in treatment and adaptive behaviors will reduce the risk for developing psychosis, if they were told they had a genetic risk for psychosis. Items are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater perceived efficacy. Measure is divided into four sub-scales: a) avoiding unhealthy behaviors (4 items range 4-16), b) engaging in healthy behaviors (5 items range 5-20), c) utilizing specialized CHR services (3 items range 3-12), and d) help-seeking behaviors (6 items range 6-24). Changes in scores from pre- to post-intervention are reported.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline, immediately post-intervention, up to 30 minutes
• Results posted on: 2024-03-19

Participant Flow

Participant milestones

Measure	Clinician Manual Participants were introduced to a trained clinician and completed a 60-minute session on genetic counseling material
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis

Baseline characteristics by cohort

Measure	Clinician Manual n=25 Participants Participants were introduced to a trained clinician and completed a 60-minute session on genetic counseling material
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Female	9 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	14 Participants n=5 Participants
Sex/Gender, Customized Gender · Other	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Perceived Treatment Efficacy Avoiding Unhealthy Behaviors	11.9 score on a scale STANDARD_DEVIATION 3.2 • n=5 Participants
Perceived Treatment Efficacy Engaging in Healthy Behaviors	13.5 score on a scale STANDARD_DEVIATION 2.8 • n=5 Participants
Perceived Treatment Efficacy Specialized CHR clinic	9.6 score on a scale STANDARD_DEVIATION 1.9 • n=5 Participants
Perceived Treatment Efficacy Help Seeking	17.5 score on a scale STANDARD_DEVIATION 3.3 • n=5 Participants
Intention to Use Treatment Avoiding unhealthy behaviors	12.7 score on a scale STANDARD_DEVIATION 2.9 • n=5 Participants
Intention to Use Treatment Engaging in healthy behaviors	13.8 score on a scale STANDARD_DEVIATION 2.8 • n=5 Participants
Intention to Use Treatment Specialized CHR clinic	7.1 score on a scale STANDARD_DEVIATION 1.3 • n=5 Participants
Intention to Use Treatment Help Seeking	17.3 score on a scale STANDARD_DEVIATION 3.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, immediately post-intervention, up to 30 minutes

Population: Participants were clinically high risk youth who were in a key period of identity formation.

Asks participants to rate the likelihood that engaging in treatment and adaptive behaviors will reduce the risk for developing psychosis, if they were told they had a genetic risk for psychosis. Items are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater perceived efficacy. Measure is divided into four sub-scales: a) avoiding unhealthy behaviors (4 items range 4-16), b) engaging in healthy behaviors (5 items range 5-20), c) utilizing specialized CHR services (3 items range 3-12), and d) help-seeking behaviors (6 items range 6-24). Changes in scores from pre- to post-intervention are reported.

Outcome measures

Measure	Clinician Manual n=24 Participants Participants were introduced to a trained clinician and completed a 60-minute session on genetic counseling material
Change From Baseline in Perceived Treatment Efficacy Help Seeking Behaviors	0.5 score on a scale Standard Deviation 2.1
Change From Baseline in Perceived Treatment Efficacy Avoiding Unhealthy Behaviors	2.6 score on a scale Standard Deviation 2.9
Change From Baseline in Perceived Treatment Efficacy Engaging in Healthy Behaviors	1.6 score on a scale Standard Deviation 2.6
Change From Baseline in Perceived Treatment Efficacy Going to a specialized CHR Clinic	0.5 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline, Immediately post-intervention, up to 30 minutes

Population: Participants were clinically high risk youth who were in a key period of identity formation.

Asks participants to rate the likelihood of engaging in treatment and adaptive behaviors, if they were told they had a genetic risk for psychosis. Items are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater intention. The measure was divided into four sub-scales: a) avoiding unhealthy behaviors (4 items range 4-16), b) engaging in healthy behaviors (5 items range 5-20), c) utilizing specialized CHR services (2 items range 2-8), and d) help-seeking behaviors (6 items range 6-24). Changes were measured pre- and post-intervention.

Outcome measures

Measure	Clinician Manual n=24 Participants Participants were introduced to a trained clinician and completed a 60-minute session on genetic counseling material
Change From Baseline in Intention to Use Treatment Avoiding unhealthy behaviors	0.9 score on a scale Standard Deviation 1.1
Change From Baseline in Intention to Use Treatment Engaging in healthy behaviors	1.0 score on a scale Standard Deviation 2.4
Change From Baseline in Intention to Use Treatment Going to a specialized CHR clinic	-0.3 score on a scale Standard Deviation 1.0
Change From Baseline in Intention to Use Treatment Help Seeking behaviors	-0.5 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline, Immediately post-intervention, up to 30 minutes

Population: Participants were clinically high risk youth who were in a key period of identity formation.

Assess participants self-stigma if they were told they had a genetic risk for psychosis. 7 items are included: I believe I would be fundamentally different from most people (range 1-4), I would be more likely to do something violent towards other people (range 1-4), I would be more likely to do something violent towards myself (range 1-4), I would be more likely to be unpredictable (range 1-4), I would feel ashamed of myself (range 1-4), I would feel embarrassed about myself (range 1-4), I would think of myself as less competent (range 1-4). each measured on a 4-point scale (1=strongly disagree, 2=somewhat disagree, 3=somewhat agree, 4=strongly agree), with higher scores indicating greater stigma. Change in scores from pre- to post-intervention are reported.

Outcome measures

Measure	Clinician Manual n=24 Participants Participants were introduced to a trained clinician and completed a 60-minute session on genetic counseling material
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development I believe I would be fundamentally different from most people	-0.04 score on a scale Standard Deviation 1.0
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development I would be more likely to do something violent towards other people	0.0 score on a scale Standard Deviation 0.5
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development I would be more likely to do something violent towards myself	0.2 score on a scale Standard Deviation 0.5
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development I would be more likely to be unpredictable	-0.3 score on a scale Standard Deviation 0.9
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development I would feel ashamed of myself	-0.4 score on a scale Standard Deviation 0.6
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development I would feel embarrassed about myself	-0.3 score on a scale Standard Deviation 0.6
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development I would think of myself as less competent	-0.3 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline, Immediately post-intervention, up to 30 minutes

Population: Participants were clinically high risk youth who were in a key period of identity formation.

Assess participants anticipated discrimination if they were told they had a genetic risk for psychosis. 18 items (each with a range of 1-4) are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater anticipated stigma. Because this is an exploratory R21 trial, the investigators are also testing and validating new measures for this specific group and purpose however, this is based off a published discrimination scale (Wahl, 1999). Change in scores from pre- to post-intervention for each item are reported.

Outcome measures

Measure	Clinician Manual n=24 Participants Participants were introduced to a trained clinician and completed a 60-minute session on genetic counseling material
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being treated differently by mental health professionals	-0.3 score on a scale Standard Deviation 1.1
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of having trouble keeping or getting a job	-0.4 score on a scale Standard Deviation 0.8
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being misunderstood by family	0.0 score on a scale Standard Deviation 0.9
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being rejected by family	0.0 score on a scale Standard Deviation 0.7
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of having friends/acquaintances become more distant from you	-0.04 score on a scale Standard Deviation 0.7
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being targeted by hurtful social media messages	0.3 score on a scale Standard Deviation 0.7
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of having your friends/acquaintances talk badly about you	0.1 score on a scale Standard Deviation 0.6
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of having your friends/acquaintances be afraid of you	0.1 score on a scale Standard Deviation 0.6
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of losing your friends	0.04 score on a scale Standard Deviation 0.7
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being looked down on by other people	-0.2 score on a scale Standard Deviation 0.9
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being overly vigilant that you might become symptomatic	-0.2 score on a scale Standard Deviation 0.7
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being viewed as someone who is unworthy of trust	0.0 score on a scale Standard Deviation 0.9
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being treated as an object of pity	0.04 score on a scale Standard Deviation 0.8
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of having your insurance status affected	-0.2 score on a scale Standard Deviation 1.1
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of having a school not admit you	0.04 score on a scale Standard Deviation 0.7
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of having an employer not hire you	0.2 score on a scale Standard Deviation 1.0
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of having trouble dating	-0.3 score on a scale Standard Deviation 0.9
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Likelihood of being concerned about having children in the future	-0.3 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline, Immediately post-intervention, up to 30 minutes

Population: Participants were clinically high risk youth who were in a key period of identity formation.

Assess participants anticipated rejection if they were told they had a genetic risk for psychosis. 3 items (each with a range of 1-4) measured on a 4-point scale (1=very unconcerned, 2=somewhat unconcerned, 3=somewhat concerned, 4=very concerned), with higher scores indicating greater anticipated rejection. Because this is an exploratory R21 trial, the investigators are also testing and validating new measures for this specific group and purpose; however, these items are based off of a published rejection sensitivity scale (Link, Wells, Phelan, Yang, 2015). Change in scores from pre- to post- intervention for each item are reported.

Outcome measures

Measure	Clinician Manual n=24 Participants Participants were introduced to a trained clinician and completed a 60-minute session on genetic counseling material
Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development Scenario 1: Dinner with friends	-0.2 score on a scale Standard Deviation 1.1
Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development Scenario 2: Argument with a friend	-0.4 score on a scale Standard Deviation .8
Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development Scenario 3: Dating someone new	-0.1 score on a scale Standard Deviation 1.1

Adverse Events

Clinician Manual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lawrence Yang

New York University

Phone: (212) 992-6334

Email: lawrence.yang@nyu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place