Project COPE (Coping Options for Parent Empowerment)

Not Applicable

Completed

• Conditions: Anxiety Disorders; Depression
• Interventions: Behavioral: UP-Caregiver

• Registration Number: NCT04715906
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Study Start: 2021-02-22
• Primary Completion: 2022-01-26
• Study Completion: 2022-02-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UP-Caregiver Group	UP-Caregiver	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.

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms as measured by the PHQ	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.
Change in Anxiety levels as measured by GAD-7	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.

Secondary Outcome Measures

Name	Time	Method
Change in Hope as measured by the State Hope Scale	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.
Change in parenting beliefs as measured by the PSOC Scale	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.
Acceptability of Intervention as measured by the Program Feedback Scale	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States