Project COPE (Coping Options for Parent Empowerment)

University of Miami

Status: Completed

Conditions: Depression; Anxiety Disorders

Treatments: Behavioral: UP-Caregiver

Study type: Interventional

Funder types: Other

Identifiers

NCT04715906

20201530

Details and patient eligibility

About

The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers of children with Autism Spectrum Disorder (ASD) cope with these stressors.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must be willing to consent to participate via RedCap
2. Indicate a mild or greater elevation on screening measures of anxiety and/or depression
3. Not meet any exclusion criteria.
4. Lives in Florida
5. Has a child between the ages of 4-13 years who has been diagnosed with ASD
6. Speaks either English or Spanish primarily
7. Has technical capacity to participate in Zoom sessions on a mobile device or preferably a computer

Exclusion criteria

1. Severe mental illness (e.g., bipolar disorder, schizophrenia, an intellectual disability, psychosis, alcohol use disorder, substance use disorder) or hospitalization for mental health concerns or suicide attempt. Parents may receive concurrent psychiatric or psychological intervention services but may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate.
2. Parents who report any prior arrest for child endangerment, child abuse or child neglect may also be excluded.
3. Parents who have Moderate or greater risk of suicidal ideation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

UP-Caregiver Group

Experimental group

Description:

Unified Protocol (UP) Caregiver Group will receive the UP for Transdiagnostic Treatment of Emotional Disorders for Caregivers intervention via telehealth using Zoom for a minimum of 4 up to 8 sessions ideally within 8 weeks.

Treatment:

Behavioral: UP-Caregiver