Anxiety DisordersNCT04715906
Project COPE (Coping Options for Parent Empowerment)
A study testing UP-Caregiver in people with Anxiety Disorders and Depression, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- UP-Caregiver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 16 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- UP-Caregiver
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UP-CaregiverBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| UP-Caregiver Group | Experimental | 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. Receives: Behavioral: UP-Caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 Weeks
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.
Measured: Baseline, 6 Weeks
Secondary outcomes (3)
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.
Measured: Baseline, 6 Weeks
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.
Measured: Baseline, 6 Weeks
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.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start22 Feb 2021
- Primary completion26 Jan 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Trust, Miami FL
- Responsible party
- Principal investigator, Jill May Ehrenreich, University of Miami
- Investigators
- Jill Ehrenreich-May, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715906
- Sponsor's protocol ID
- 20201530
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Options for Parent Empowerment
- ClinicalTrials.gov ID
- NCT04715906
- Acronym / sponsor ID
- 20201530
- Conditions
- Anxiety Disorders, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Children's Trust, Miami FL
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UP-Caregiver Group | Experimental | Behavioral: UP-CaregiverUnified 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UP-CaregiverThe 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. | Behavioural | UP-Caregiver Group |
Primary outcome
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.
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.
3 secondary outcomes
Change in parenting beliefs as measured by the PSOC Scale
Time frame: Baseline, 6 Weeks
Change in Hope as measured by the State Hope Scale
Time frame: Baseline, 6 Weeks
Acceptability of Intervention as measured by the Program Feedback Scale
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
RecruitingObservational study
Sensory Profile of People With High Intellectual Potential (HIP)
High Intellectual Potential
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Ehrenreich-May, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UP-Caregiver in people with Anxiety Disorders and Depression, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety levels as measured by GAD-7 (time frame: Baseline, 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 2 Nov 2026.