Project COPE (Coping Options for Parent Empowerment)

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT04715906
Collaborator
The Children's Trust (Other)
35
1
1
11.8
3

Study Details

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
  • Behavioral: UP-Caregiver
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
35 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 :
Feb 22, 2021
Actual Primary Completion Date :
Jan 26, 2022
Actual Study Completion Date :
Feb 16, 2022

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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami
  • The Children's Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jan 20, 2021
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Apr 27, 2022