Project COPE (Coping Options for Parent Empowerment)

NCT04715906 | Completed

• 1 other identifier: 20201530
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in Anxiety levels as measured by GAD-7

  Parent Psychopathology levels will be reported as the change in the Generalized Anxiety Disorder 7-item (GAD-7) scores. GAD-7 is a 7-item measure assessing the presence and severity of symptoms of anxiety. The Scale has a total score ranging from 0 to 21 with the higher scores indicating greater anxiety.

  Baseline, 6 Weeks

• Change in depressive symptoms as measured by the PHQ

  Parent Psychopathology levels will be reported as the change in the Patient Health Questionnaire (PHQ) scores. PHQ is a 9-item measure assessing the severity of depressive symptoms. It has a total score ranging from 0 to 27 with the higher scores indicating greater depressive symptoms.

  Baseline, 6 Weeks

Secondary Outcomes (3)

• Change in parenting beliefs as measured by the PSOC Scale

  Baseline, 6 Weeks

• Change in Hope as measured by the State Hope Scale

  Baseline, 6 Weeks

• Acceptability of Intervention as measured by the Program Feedback Scale

  6 Weeks

Study Arms (1)

UP-Caregiver Group

EXPERIMENTAL

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.

Behavioral: UP-Caregiver

Interventions

UP-Caregiver 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.

UP-Caregiver Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be willing to consent to participate via RedCap
• Indicate a mild or greater elevation on screening measures of anxiety and/or depression

You may not qualify if:

• Lives in Florida
• Has a child between the ages of 4-13 years who has been diagnosed with ASD
• Speaks either English or Spanish primarily
• Has technical capacity to participate in Zoom sessions on a mobile device or preferably a computer
• 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.
• Parents who report any prior arrest for child endangerment, child abuse or child neglect may also be excluded.
• Parents who have Moderate or greater risk of suicidal ideation.

Sponsors & Collaborators

• University of Miami: lead
• The Children's Trust, Miami FL: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jill Ehrenreich-May, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assistant Chair for Academic Affairs and Research

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 20, 2021
• Study Start: February 22, 2021
• Primary Completion: January 26, 2022
• Study Completion: February 16, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)