Back to resultsProject COPE (Coping Options for Parent Empowerment)
Primary Purpose
Anxiety Disorders, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UP-Caregiver
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UP-Caregiver Group
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04715906
First Posted
December 29, 2020
Last Updated
April 26, 2022
Sponsor
University of Miami
Collaborators
The Children's Trust, Miami FL
1. Study Identification
Unique Protocol Identification Number
NCT04715906
Brief Title
Project COPE (Coping Options for Parent Empowerment)
Official Title
Coping Options for Parent Empowerment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
January 26, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Children's Trust, Miami FL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UP-Caregiver Group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
UP-Caregiver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Anxiety levels as measured by GAD-7
Description
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.
Time Frame
Baseline, 6 Weeks
Title
Change in depressive symptoms as measured by the PHQ
Description
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.
Time Frame
Baseline, 6 Weeks
Secondary Outcome Measure Information:
Title
Change in parenting beliefs as measured by the PSOC Scale
Description
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.
Time Frame
Baseline, 6 Weeks
Title
Change in Hope as measured by the State Hope Scale
Description
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.
Time Frame
Baseline, 6 Weeks
Title
Acceptability of Intervention as measured by the Program Feedback Scale
Description
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.
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Project COPE (Coping Options for Parent Empowerment)
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