Eskenazi Health, PARC Program
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
NCT Number: NCT04889911
The overall purpose of the proposed exploratory intervention development application, is to conduct research that will inform the adaptation and preliminary testing of NECT modified for youth (aged 15-24) with first episode psychosis (FEP), targeting self-concept and illness conceptions to increase treatment engagement. The specific aims of the project are to: 1) adapt NECT to be responsive to the needs and preferences of youth with FEP, and 2) Assess the feasibility, acceptability and preliminary effectiveness of the modified intervention (NECT-YA) combined with coordinated specialty care (CSC) services, compared to CSC services alone, in a small (n = 40) RCT.
Interested in participating?
Request Info15 year–24 year
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
The investigators will conduct a small RCT of the modified intervention (NECT-YA), combined with CSC, in comparison with CSC alone, with 40 persons recruited from three FEP programs, assessing acceptability and feasibility, and collecting data on primary outcome (service engagement and therapeutic alliance), related outcomes (self-esteem, hopelessness, and social functioning) and mechanisms of action (self-stigma, illness conceptions and coping). The investigators will also collect qualitative data on participants' impressions of NECT-YA, which will inform additional revisions of the manual.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Does not meet any of the above inclusion criteria.
NECT is a psychosocial intervention focused on addressing the effects of self-stigma on individuals diagnosed with severe mental illnesses. For the present study, the intervention has been modified to address the needs of youth who have recently experienced a first episode of psychosis.
Other names: NECT-YA
Coordinated Specialty Care is an evidence-based, multimodal intervention for persons who have experienced a first episode of psychosis.
Other names: CSC
Time frame: 0 minutes
Quantity of service use will be measured using attendance records for groups collected by facilitators, as well as administrative data on total service use within the FEP programs.
Time frame: 2 minutes
A 12-item self-report measure of perception of relationship with the treatment team. Higher scores indicate better working alliance.
Time frame: 15 minutes
Assesses the use of problem-centered, neutral and avoidant coping strategies to deal with a variety of psychiatric symptoms commonly experienced by people with severe mental illnesses. Higher scores in each subscale indicate more use of that type of coping strategy.
Time frame: 3 minutes
The Beck Hopelessness Scale is a well-established 20-item scale that will be used to measure pessimistic expectations of the future. Individual items are summed to provide an overall index of hope or its absence. Higher scores indicate less hope.
Time frame: 2 minutes
The Rosenberg Self Esteem Schedule will be used to measure self-esteem and self-deprecation. Higher scores indicate more self-esteem.
Time frame: 20 minutes
The Quality of Life Scale is a 21-item scale completed by clinically trained research staff following a semi-structured interview that assesses social functioning in multiple domains. Higher scores indicate great social functioning.
Time frame: 5 minutes
A 29 item measure of internalized stigma. Higher scores indicate great internalized stigma.
Time frame: 20 minutes
The Positive and Negative Syndrome Scale is a 30-item rating scale of psychiatric symptoms associated with psychosis, completed following a chart review and semi-structured interview. Higher scores indicate more symptoms.
Time frame: 5 minutes
The Recovery Style Questionnaire is a 39 item self-report scale designed to assess the extent to which people with psychosis engage in "sealing over" versus "integration" with regard to how their self-conception.
Contact information is provided by the study sponsor or research team.
John Jay College of Criminal Justice, City University of New York
Other
Development of a Stage-specific Adaptation of a Self-stigma Intervention for People Recovering from a First Episode of Psychosis
Acronym: NECT-YA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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