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OpenTrials
Completed

NCT Number: NCT04715906

Project COPE (Coping Options for Parent Empowerment)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UP-Caregiver

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in parenting beliefs as measured by the PSOC Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Children's Trust, Miami FL

Registry information

Official study title

Coping Options for Parent Empowerment

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2021
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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