AnxietyCo-PARENTNCT04431856
CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
A study testing Unified Protocol for COVID-19 Parenting Stress (UP-COVID) and SHG in people with Anxiety 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 cope with these stressors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Traumatic Stress Disorder
- What is being tested?
- Unified Protocol for COVID-19 Parenting Stress (UP-COVID) and SHG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 17 Nov 2020
- 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
- consent to participate via RedCap
- indicate a mild or greater elevation on screening measures of anxiety, depression and/or traumatic stress
- have a child between 6 and 13 years
- speak/read English or Spanish fluently
Who cannot join
- reported 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.
- reported prior arrest for child endangerment, child abuse or child neglect, or prior investigation by the Florida Department of Children and Families (DCF)
- may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers cope with these stressors.
- Conditions
- Anxiety, Depression, Traumatic Stress Disorder
- Being tested
- Unified Protocol for COVID-19 Parenting Stress (UP-COVID), SHG
- Keywords
- COVID-19
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Traumatic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for COVID-19 Parenting Stress (UP-COVID)Behavioural
UP-COVID is a group therapy session with each session lasting approximately 60-90 minutes. The sessions will focus on cognitive and behavioral strategies for managing their own distress, anxiety and sadness related to COVID-19, as well as, strategies related to parenting in the midst of the crisis.
SHGBehavioural
Brochure that details techniques for coping with stress.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Condition | Experimental | Participants in the Immediate Condition group will receive a total of 4 sessions of Unified Protocol for COVID-19 Parenting Stress (UP-COVID) intervention Receives: Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID) |
| Delayed Condition | Active comparator | Participants in the Delayed Condition group will receive the Self Help Guide (SHG) by the National Child Traumatic Stress Network (NCTSN). They will then receive the UP-COVID intervention following their week 6 assessment Receives: Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID); Behavioral: SHG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Anxiety as assessed by the OASIS
The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5 self-reported questionnaire evaluating the severity and functional impairment due to anxiety. The total score ranges from 0 (no anxiety) to 20 (severe anxiety).
Measured: week 6 and week 12
Measure of Depression as assessed by the ODSIS
Overall Depression Severity and Impairment Scale (ODSIS) is a 5-item measure assessing the frequency and intensity of depressive symptoms. The total score ranges from 0-20 with the higher score indicating increased depression.
Measured: week 6 and week 12
Measure of PTSD as assessed by the PCL-5
PTSD Checklist (PCL-5) is a 20-item measure of PTSD symptoms in adults. Total score ranges from 0 to 80 with the higher score indicating higher PTSD symptoms.
Measured: week 6 and week 12
Secondary outcomes (4)
Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU
The Egna Minnen Betraffande Uppfostran - Short Form (S-EMBU) is a 9-item measure that assesses parents' perception of their overprotection/control. Total scores ranging from 9 (low overcontrol) to 36 (high overcontrol).
Measured: week 6 and week 12
Measure of Parenting Rejection as assessed by the S-EMBU
The Egna Minnen Betraffande Uppfostran - Short Form is a 7-item measure that assesses parents' perception of their rejection. Total score ranging from 7 (low rejection) to 28 (high rejection).
Measured: week 6 and week 12
Measure of Parenting Emotional Warmth as assessed by the S-EMBU
The Egna Minnen Betraffande Uppfostran - Short Form is a 6-item measure that assesses parents' perception of their emotional warmth. Total scores ranging from 6 (low warmth) to 24 (high warmth).
Measured: week 6 and week 12
Measure of Parent Accommodation for Child Anxiety as assessed by the FASA
The Family Accommodation Scale - Anxiety (FASA) is a 13-item measure that assesses parent's accommodation of their child's anxiety related behaviors. Total scores range from 0 (low accommodation) to 52 (high accommodation).
Measured: week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 May 2020
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill May Ehrenreich, University of Miami
- Investigators
- Jill Ehrenreich-May, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431856
- Sponsor's protocol ID
- 20200484
- Acronym
- Co-PARENT
- Status last verified
- Nov 2020
- First submitted
- 12 Jun 2020
- Last updated
- 1 Dec 2020
- 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
- ClinicalTrials.gov ID
- NCT04431856
- Acronym / sponsor ID
- Co-PARENT / 20200484
- Conditions
- Anxiety, Depression, Traumatic Stress Disorder
- Keywords
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 16 Jun 2020 (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 cope with these stressors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Condition | Experimental | Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID)Participants in the Immediate Condition group will receive a total of 4 sessions of Unified Protocol for COVID-19 Parenting Stress (UP-COVID) intervention |
| Delayed Condition | Active comparator | Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID), Behavioral: SHGParticipants in the Delayed Condition group will receive the Self Help Guide (SHG) by the National Child Traumatic Stress Network (NCTSN). They will then receive the UP-COVID intervention following their week 6 assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- consent to participate via RedCap
- indicate a mild or greater elevation on screening measures of anxiety, depression and/or traumatic stress
- have a child between 6 and 13 years
- speak/read English or Spanish fluently
Key exclusion criteria (3 listed)
- reported 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.
- reported prior arrest for child endangerment, child abuse or child neglect, or prior investigation by the Florida Department of Children and Families (DCF)
- may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate
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 |
|---|---|---|
| Unified Protocol for COVID-19 Parenting Stress (UP-COVID)UP-COVID is a group therapy session with each session lasting approximately 60-90 minutes. The sessions will focus on cognitive and behavioral strategies for managing their own distress, anxiety and sadness related to COVID-19, as well as, strategies related to parenting in the midst of the crisis. | Behavioural | Delayed Condition, Immediate Condition |
| SHGBrochure that details techniques for coping with stress. | Behavioural | Delayed Condition |
Primary outcome
Measure of Anxiety as assessed by the OASIS
Time frame: week 6 and week 12
The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5 self-reported questionnaire evaluating the severity and functional impairment due to anxiety. The total score ranges from 0 (no anxiety) to 20 (severe anxiety).
Measure of Depression as assessed by the ODSIS
Time frame: week 6 and week 12
Overall Depression Severity and Impairment Scale (ODSIS) is a 5-item measure assessing the frequency and intensity of depressive symptoms. The total score ranges from 0-20 with the higher score indicating increased depression.
Measure of PTSD as assessed by the PCL-5
Time frame: week 6 and week 12
PTSD Checklist (PCL-5) is a 20-item measure of PTSD symptoms in adults. Total score ranges from 0 to 80 with the higher score indicating higher PTSD symptoms.
4 secondary outcomes
Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU
Time frame: week 6 and week 12
Measure of Parenting Rejection as assessed by the S-EMBU
Time frame: week 6 and week 12
Measure of Parenting Emotional Warmth as assessed by the S-EMBU
Time frame: week 6 and week 12
Measure of Parent Accommodation for Child Anxiety as assessed by the FASA
Time frame: week 6 and week 12
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 1 Dec 2020.
- Individual participant dataSharing planned: No
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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, Ph.D. 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 Unified Protocol for COVID-19 Parenting Stress (UP-COVID) and SHG in people with Anxiety 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 4 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 1 Dec 2020. 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?
Measure of Anxiety as assessed by the OASIS (time frame: week 6 and week 12). The study lists 3 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 1 Dec 2020.