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Clinical Trials/NCT04715906
NCT04715906
Completed
N/A

Coping Options for Parent Empowerment

University of Miami1 site in 1 country35 target enrollmentFebruary 22, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
University of Miami
Enrollment
35
Locations
1
Primary Endpoint
Change in depressive symptoms as measured by the PHQ
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
February 16, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jill May Ehrenreich

Professor, Assistant Chair for Academic Affairs and Research

University of Miami

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.

Outcomes

Primary Outcomes

Change in depressive symptoms as measured by the PHQ

Time Frame: 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

Time Frame: 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 Outcomes

  • Change in Hope as measured by the State Hope Scale(Baseline, 6 Weeks)
  • Change in parenting beliefs as measured by the PSOC Scale(Baseline, 6 Weeks)
  • Acceptability of Intervention as measured by the Program Feedback Scale(6 Weeks)

Study Sites (1)

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