Project COPE (Coping Options for Parent Empowerment)

• ClinicalTrials.gov Identifier: NCT04715906
• Recruitment Status: Recruiting
• First Posted: January 20, 2021
• Last Update Posted: June 9, 2021
• Sponsor: University of Miami
• Collaborator: The Children's Trust
• Information provided by (Responsible Party): Jill May Ehrenreich, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anxiety Disorders; Depression	Behavioral: UP-Caregiver	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Coping Options for Parent Empowerment
• Actual Study Start Date: February 22, 2021
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Anxiety levels as measured by GAD-7 [ Time Frame: Baseline, 6 Weeks ]
   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.
2. Change in depressive symptoms as measured by the PHQ [ Time Frame: Baseline, 6 Weeks ]
   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.

Secondary Outcome Measures :

1. Change in parenting beliefs as measured by the PSOC Scale [ Time Frame: Baseline, 6 Weeks ]
   Parenting Sense of Competence (PSOC) scale is a 17-item measure of parenting self-efficacy and satisfaction. It has a total score ranging from 17 to 102 with the higher scores indicating greater self-efficacy and satisfaction in the parenting role.
2. Change in Hope as measured by the State Hope Scale [ Time Frame: Baseline, 6 Weeks ]
   State Hope Scale is a 6-item measure designed to evaluate hope in adults. It has a total score ranging from 6 to 48 with the higher scores representing higher hope levels.
3. Acceptability of Intervention as measured by the Program Feedback Scale [ Time Frame: 6 Weeks ]
   The Program Feedback Scale has a total score ranging from 0 to 28 with the higher score indicating perceived acceptability and feasibility of the program.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
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.

Contacts and Locations

Contacts

Contact: Elizabeth Halliday, BS; 305-284-2712; erh24@miami.edu

Locations

United States, Florida

University of Miami; Recruiting

Miami, Florida, United States, 33136

Contact: Elizabeth Halliday erh24@miami.edu

Principal Investigator: Jill Ehrenreich-May

Sponsors and Collaborators

University of Miami

The Children's Trust

Investigators

• Principal Investigator: Jill Ehrenreich-May, PhD; University of Miami

More Information

• Responsible Party: Jill May Ehrenreich, Professor, Assistant Chair for Academic Affairs and Research, University of Miami
• ClinicalTrials.gov Identifier: NCT04715906
• Other Study ID Numbers: 20201530
• First Posted: January 20, 2021
• Last Update Posted: June 9, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders