Project COPE (Coping Options for Parent Empowerment)

Depression Clinical Trial

Official title:

Coping Options for Parent Empowerment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04715906
• Other study ID #: 20201530
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: February 16, 2022

Study information

• Verified date: April 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 16, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Children's Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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