Ascertaining Diagnosis Classification With Elicited Speech

Attention Deficit Hyperactivity Disorder Clinical Trial

— ACES  

Official title:

Ascertaining Diagnosis Classification With Elicited Speech

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601063
• Other study ID #: 20-0468
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cross-sectional observational study of the relationship between speech patterns and psychiatric symptoms and disorders.

Description:

Major psychiatric disorders often occur together in the same patient and it can be difficult to distinguish between disorders with overlapping symptoms. The majority of patients with mental illness receive treatment in settings where it is not feasible to conduct detailed diagnostic interviews or neuropsychiatric testing. A cost-effective and efficient tool is needed for accurate diagnosis. Looking at language is an efficient way of making sense of the brain because it is easily observed and reflects brain circuitry. Automated natural language processing (NLP) can help us do this objectively, efficiently, and with high sensitivity. The investigators aim to use linguistic features extracted using natural language processing to aid in diagnostic classification and in predicting dimensional symptoms. This will be done by obtaining clinical diagnoses, language samples, and self-report scales from 604 participants with a variety of psychiatric symptoms. Adolescents will also be included and the investigators will try to predict diagnosis in adolescents using models that were built on adult data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

Inclusion Criteria:

• Speaks with conversational proficiency with conversational proficiency
• Current diagnosis in the medical chart of any of the following. The patient may be in partial but not full remission. Comorbidity among these disorders and other unlisted disorders is expected and allowable.
• Schizophrenia-spectrum disorder - schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or unspecified psychotic disorder
• Bipolar spectrum disorder - bipolar I or II disorder, cyclothymia, unspecified or other specified bipolar disorder
• (Unipolar) Depressive disorder - major depressive disorder, dysthymia, unspecified and other specified depressive disorder
• Anxiety disorder - obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, post-traumatic stress disorder
• Personality disorder - borderline personality disorder
• Attention-Deficit Hyperactivity Disorder
• Healthy comparison subjects
• Age 14 - 50 years
• Has capacity and willing to sign informed consent; if minor, parent is willing to give consent and child is willing to give assent.
• Screening will not include a pregnancy test. Pregnant women will not be screened out of the study because the study procedures are of very low risk overall, and pregnancy does not place the participant or the fetus at any significant risk.
• Minors will be included in the study because diagnostic ambiguity is prevalent before the age of 18 and this patient group is particularly in need of accurate prognosis and treatment. Therefore, it is of vital importance that the conclusions of the study be applicable to minors and that they be included among the participants.

Exclusion Criteria:

• Participants with substance-induced disorders or disorders secondary to a general medical condition will not be included as underlying brain changes may be different from "primary" psychiatric disorders.
• Disorders affecting speech or language, such as aphasia, intellectual disability (IQ<70), or language disorder, or movement disorders affecting speech like tardive dyskinesia, or physical impairments causing significant distortions to speech
• Serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain and/or language, including but not limited to: neurodegenerative disorders, traumatic brain injury with active symptoms, autism spectrum disorder, encephalitis, epilepsy
• Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent

Related Conditions & MeSH terms

• Anxiety Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Bipolar and Related Disorders
• Depressive Disorder
• Disease
• Personality Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders

Intervention

Behavioral:
• Winterlight Speech Assessment
Digital assessment of speech and language abilities

Locations

Country	Name	City	State
United States	Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Winterlight Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech features from the Winterlight Speech Assessment	Acoustic and linguistic measures of speech computed based on performance on the Winterlight Speech Assessment	Baseline
Secondary	Brief Symptom Inventory	53 item. Range = 0, not at all - 4, extremely. Higher scores resulting in worse outcome.; TLC: Scale for the Assessment of Thought Language and Communication	Baseline
Secondary	Patient Health Questionnaire - 9	9 item. Range = 0, not at all - 3, nearly every day. Higher scores resulting in worse outcome.	Baseline
Secondary	Generalized Anxiety Disorder - 7	7 item. Range = 0, not at all - 3, nearly every day. Higher scores resulting in worse outcome.	Baseline
Secondary	Prodromal Questionnaire - Brief	18 item. Range = 0, no - 1, yes. Higher scores resulting in worse outcome.	Baseline
Secondary	Scale for the Assessment of Thought Language and Communication	20 item, range= 0, absent - 3, severe; higher scores resulting in worse outcome.	Baseline