Project COPE (Coping Options for Parent Empowerment)

NCT ID: NCT04715906

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2022-02-16

Brief Summary

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.

Conditions

Anxiety Disorders; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UP-Caregiver Group

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.

Group Type: EXPERIMENTAL

UP-Caregiver

Intervention Type: BEHAVIORAL

The Unified Protocol (UP) is a telehealth group session using Zoom with each session lasting approximately 60-90 minutes. The sessions will focus on a variety of Cognitive Behavior Therapy techniques. These sessions may include teaching coping skills, goal setting, parent-child problem solving and communication, and motivation during this pandemic.

Interventions

UP-Caregiver

The Unified Protocol (UP) is a telehealth group session using Zoom with each session lasting approximately 60-90 minutes. The sessions will focus on a variety of Cognitive Behavior Therapy techniques. These sessions may include teaching coping skills, goal setting, parent-child problem solving and communication, and motivation during this pandemic.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Trust, Miami FL

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Jill May Ehrenreich

Professor, Assistant Chair for Academic Affairs and Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Ehrenreich-May, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20201530

Identifier Type: -

Identifier Source: org_study_id