Role Functioning Changes NOS

Role Functioning Changes in New Onset Symptoms

During this study the investigators will 1) collect measures of social cognition and social functioning in adolescents and young adults who are experiencing early symptoms of a major mental disorder; and 2) evaluate the predictive value and utility of a new role functioning assessment measure for individuals experiencing changes in their lives after an index episode of mental illness. This will happen in the context of providing treatment-as-usual to individuals who arrive seeking help with the early phases of mental illness.

Study Overview

• Status: Terminated
• Conditions: Psychotic Disorders; Schizophrenia; Bipolar Disorder
• Intervention / Treatment: Drug: Pharmacotherapy; Behavioral: Behavioral treatment

Detailed Description

The early symptoms of major mental disorders, such as bipolar disorder and schizophrenia, can be non-specific, attenuated, or intermittent. These symptoms nevertheless frequently interfere with an individuals' ability to effectively carry-out multiple aspects of their everyday lives, including social, vocational, and educational functioning. Functional changes may in fact occur before individual symptoms reach the threshold for clinical significance. Relying solely on the emergence of early symptoms of psychopathology can delay treatment or lead to the improper selection of treatments that are not effective. Therefore, measuring changes in real-world functioning that correlate with or predate symptoms may be a useful tool for developing an effective treatment plan.

While psychopharmacology and psychotherapy can improve some symptoms of severe mental illness, much less is known about the mechanisms for improving impairments in social cognition. Importantly social cognition affects not just social functioning, but many critical aspects of real-world functioning. Thus, advancing our understanding of how social cognition and real-world functioning change over time, and their association to changing clinical symptoms, will help improve our understanding of early mental illness, and should inform patient care in new ways. Currently, there are only a limited number of tools available for assessing aspects of real-world functioning as they connect to social cognition. Therefore, the overarching goal of the present study is to conduct a pilot study to develop a new tool that measures functioning and evaluate the relationship between this new tool and measures of social cognition and symptoms.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Young adults with emerging psychopathology. Therefore, all subjects we recruit will be in the age range spanning adolescence and young adulthood, who come to a clinic seeking psychiatric care.

Description

Inclusion Criteria:

1. Age 18 to 26 years
2. Individuals seeking treatment for psychiatric symptoms in a clinical care setting
3. Able to provide informed consent (age 18-26)
4. Subjects must consent to a review of the medical records in order to track changes in clinical symptoms
5. Fluent in English

Exclusion Criteria:

1. Adults unable to consent
2. Individuals who have not reached the age of 18
3. Pregnant women
4. Prisoners.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment seeking patients; Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning.	Drug: Pharmacotherapy; Participants may receive pharmacotherapy in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.; Behavioral: Behavioral treatment; Participants may receive behavioral treatment in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONS	Profile of non-verbal sensitivity	1 year
TASIT	The Awareness of Social Inference Test	1 year
BLERT	Bell-Lysaker Emotion Recognition Task	1 year
SFS	Social Functioning Scale	1 year
UPSA	UCSD Performance-Based Skills Assessment	1 year
EPT	Emotional Perspective-Taking Task	1 year
FAP	Facial Affect Perception Task	1 year
Informant SLOF	Informant Specific Levels of Functioning Scale; administered to an informant of a participant	1 year
SLOF	Specific Levels of Functioning Scale	1 year
RFS	Role Functioning Scale	1 year
ERS	Emotional Reactivity Scale	1 year
ASSIST	Alcohol, Smoking and Substance Involvement Screening Test	1 year

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Will J Cronenwett, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cognition; Early mental illness; Role functioning
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: STU00201133