Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-01 @ 4:56 PM
Study NCT ID:
NCT05426057
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Health in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 468}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2022-06-15', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression symptoms', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in depression symptom severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater depression symptom severity.'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in anxiety symptom severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater anxiety symptom severity.'}, {'measure': 'Suicidality', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in suicidality severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater suicidality symptom severity.'}, {'measure': 'Change in drug use', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in drug use will be reported as the number of days drug use was reported over the last 90 days.'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CESD)', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in depression symptoms will be assessed with the CESD. Scores range from 0 to 60 with higher scores indicating the presence of more symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in Family Functioning as assessed by the Parenting Practices Questionnaire', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in family functioning will be reported using nine items from the Parenting Practices Questionnaire . Response range varies based on questions, but most response items range from 0 to 4 with higher values indicating better parenting. Scores range from 0 to 36.'}, {'measure': 'Change in Family Functioning as assessed by the Parent Relationship with Peer Group', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.'}, {'measure': 'Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.'}, {'measure': 'Change in unprotected sexual behavior', 'timeFrame': 'Baseline to 3 months, baseline to 6 months, baseline to 18 months', 'description': 'Change in unprotected sexual behavior will be reported as number of days of sex without a condom as reported over the last 90 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['effectiveness-implementation type 1 hybrid trial', 'Latinx mental health in primary care', 'Latinx adolescent', 'eHealth intervention', 'Familias Unidas', 'intervention sustainment', 'parent-centered', 'family functioning', 'sexual risk behavior'], 'conditions': ['Depression, Anxiety', 'Suicide', 'Drug Use']}, 'referencesModule': {'references': [{'pmid': '37071612', 'type': 'DERIVED', 'citation': 'Estrada Y, Lozano A, Boga D, Tapia MI, Perrino T, Velazquez MR, Forster L, Torres N, Morales CV, Gwynn L, Beardslee WR, Brown CH, Prado G. eHealth Familias Unidas Mental Health: Protocol for an effectiveness-implementation hybrid Type 1 trial to scale a mental health preventive intervention for Hispanic youth in primary care settings. PLoS One. 2023 Apr 18;18(4):e0283987. doi: 10.1371/journal.pone.0283987. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female and male adolescents, who self-identify as Hispanic (or Latino(a))\n2. Adolescent between the ages of 12 - 16 years\n3. Adolescent living with an adult primary caregiver who is willing to participate\n4. Families must have broadband internet access on a device, including (but not limited to) a smartphone, iPad, tablet, computer at their home or other location (e.g., school, library, etc.)\n5. Families screening positive on poor family communication (a score of less than 75 on the communication measure; see measures) or youth reporting elevated depressive or anxiety symptom scores (defined as 70 to 90 on the K-CAT) or a history of suicide behavior (ideation or attempts).\n\nExclusion Criteria:\n\n* Families reporting plans to move out of the South Florida area during the study period.'}, 'identificationModule': {'nctId': 'NCT05426057', 'briefTitle': 'Mental Health in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care', 'orgStudyIdInfo': {'id': '20210286'}, 'secondaryIdInfos': [{'id': '1R01MH124718-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH124718-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eHealth Familias Unidas', 'description': 'Participants in this group will receive eHealth Familias Unidas-Mental Health. The intervention consists of nine video parent group sessions, one video adolescent session, and four family sessions (parents participate in a total of 13 sessions, adolescents participate in a total of five sessions) that will be delivered by a facilitator to the parent-child dyad via web-conferencing software across 13 weeks.', 'interventionNames': ['Behavioral: eHealth Familias Unidas Mental Health']}, {'type': 'NO_INTERVENTION', 'label': 'Prevention as Usual Control', 'description': 'In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.'}], 'interventions': [{'name': 'eHealth Familias Unidas Mental Health', 'type': 'BEHAVIORAL', 'description': 'eHealth Familias Unidas is a program designed to target mental health and suicide ideation and behavior. It focuses on promoting mental health by strengthening family and interpersonal protective factors. The program is provided online over a total of 13 sessions: 9 video parent group sessions, each lasting 20-40 minutes in Spanish and 4 web family sessions lasting 45 minutes in either Spanish or English, depending on participant language preference. The video parent group sessions consist of: 1) culturally syntonic telenovela/soap opera series, 2) videotaped parent group discussions, 3) interactive exercises. Web family sessions will be conducted by a trained pediatric staff member.', 'armGroupLabels': ['eHealth Familias Unidas']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33010', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Jessie Trice Community Health Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33021', 'city': 'Miami', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Broward Community Health', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33023', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Community Health of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Medlife Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33134', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Prime Care Health', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Care Resource', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luiza Mali, PhD', 'role': 'CONTACT', 'email': 'lvm852@med.miami.edu'}], 'facility': 'Mailman for Child Devlopment', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Gwynn, PhD', 'role': 'CONTACT'}], 'facility': 'Pediatric Mobile Clinic', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Gwynn, MD', 'role': 'CONTACT', 'email': 'lgwynn@med.miami.edu'}], 'facility': 'UM Pediatric Mobile Clinic', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lourdes Q Forster, MD', 'role': 'CONTACT', 'email': 'lforster@med.miami.edu'}], 'facility': 'UM UHealth Pediatrics at the Professional Arts Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diego Shmuels, MD', 'role': 'CONTACT', 'email': 'dshmuels@borinquenhealth.org'}], 'facility': 'Borinquean Medical Centers', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33145', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Belkys Bravo Clinic', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Nicklaus Children Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'South Florida Pediatric Partners', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Pediatric Consultants of Kendall, P.A.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Torres, PhD', 'role': 'CONTACT', 'email': 'n.sosa@med.miami.edu'}], 'facility': 'UHealth Pediatrics at Kendall', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33189', 'city': 'Miami', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Banyan Health Systems', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Guillermo Prado, PhD', 'role': 'CONTACT', 'email': 'gprado@miami.edu', 'phone': '305-284-2002'}, {'name': 'Yannine Estrada, PhD', 'role': 'CONTACT', 'email': 'yestrada@miami.edu', 'phone': '305-284-6191'}], 'overallOfficials': [{'name': 'Guillermo Prado, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'C. Hendricks Brown, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guillermo Prado', 'investigatorAffiliation': 'University of Miami'}}}}