Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 3:58 AM
Study NCT ID:
NCT04431856
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2020-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-06-12', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of Anxiety as assessed by the OASIS', 'timeFrame': 'week 6 and week 12', 'description': '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': 'Measure of Depression as assessed by the ODSIS', 'timeFrame': 'week 6 and week 12', 'description': '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': 'Measure of PTSD as assessed by the PCL-5', 'timeFrame': 'week 6 and week 12', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU', 'timeFrame': 'week 6 and week 12', 'description': "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)."}, {'measure': 'Measure of Parenting Rejection as assessed by the S-EMBU', 'timeFrame': 'week 6 and week 12', 'description': "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)."}, {'measure': 'Measure of Parenting Emotional Warmth as assessed by the S-EMBU', 'timeFrame': 'week 6 and week 12', 'description': "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)."}, {'measure': 'Measure of Parent Accommodation for Child Anxiety as assessed by the FASA', 'timeFrame': 'week 6 and week 12', 'description': "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)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19'], 'conditions': ['Anxiety', 'Depression', 'Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consent to participate via RedCap\n* indicate a mild or greater elevation on screening measures of anxiety, depression and/or traumatic stress\n* have a child between 6 and 13 years\n* speak/read English or Spanish fluently\n\nExclusion Criteria:\n\n* 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.\n* reported prior arrest for child endangerment, child abuse or child neglect, or prior investigation by the Florida Department of Children and Families (DCF)\n* may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate'}, 'identificationModule': {'nctId': 'NCT04431856', 'acronym': 'Co-PARENT', 'briefTitle': 'CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment', 'orgStudyIdInfo': {'id': '20200484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Condition', 'description': 'Participants in the Immediate Condition group will receive a total of 4 sessions of Unified Protocol for COVID-19 Parenting Stress (UP-COVID) intervention', 'interventionNames': ['Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Condition', 'description': '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', 'interventionNames': ['Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID)', 'Behavioral: SHG']}], 'interventions': [{'name': 'Unified Protocol for COVID-19 Parenting Stress (UP-COVID)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Delayed Condition', 'Immediate Condition']}, {'name': 'SHG', 'type': 'BEHAVIORAL', 'description': 'Brochure that details techniques for coping with stress.', 'armGroupLabels': ['Delayed Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Jill Ehrenreich-May, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jill May Ehrenreich', 'investigatorAffiliation': 'University of Miami'}}}}