Project COPE (Coping Options for Parent Empowerment)

Study Overview
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Brief Summary
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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.

Official Title
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Coping Options for Parent Empowerment

Conditions
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Anxiety Disorders, Depression

Intervention / Treatment
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* Behavioral: UP-Caregiver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be willing to consent to participate via RedCap Indicate a mild or greater elevation on screening measures of anxiety and/or depression Not meet any exclusion criteria. 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UP-Caregiver Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parenting beliefs as measured by the PSOC Scale | 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. | Baseline, 6 Weeks | 
| Change in Hope as measured by the State Hope Scale | 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. | Baseline, 6 Weeks | 
| Acceptability of Intervention as measured by the Program Feedback Scale | 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. | 6 Weeks |