Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT04958694
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Wait-list control, no masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CEDARS Intervention', 'timeFrame': '8 Weeks', 'description': 'Participants will directly benefit from taking part in the interventions by learning and putting into practice new tools to reduce and manage their stress.'}, {'measure': 'Baseline, Midpoint, and Post-Intervention Surveys', 'timeFrame': '8 weeks', 'description': 'Participants will complete a baseline survey, a mid-point survey, and a post-intervention survey (after the completion of the last CEDARS online module).'}, {'measure': 'Post-Intervention Follow-Up', 'timeFrame': '4 weeks', 'description': 'There will be one follow-up survey with participants. The final survey will be 1 month post-intervention survey.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent Behavior', 'Stress Reduction', 'Adverse Childhood Experiences (ACEs)', 'CEDARS', 'Positive Affect Intervention'], 'conditions': ['Adolescent Behavior', 'Stress Reduction', 'Adverse Childhood Experiences', 'Positive Attitude']}, 'descriptionModule': {'briefSummary': 'Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts. Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers.', 'detailedDescription': 'This intervention has been adapted based on feedback from previous focus groups with adolescents, clinical staff, community stakeholders, and a CEDARS workgroup.\n\nParticipants will be divided into two groups - 20 in the intervention group and 20 in the waitlisted group.\n\nAdolescents in the intervention group will participate in 7 weekly, 1-hour sessions. This online intervention will feature positive affect and stress reduction skills delivered via self-paced and self-guided modules. The skills are taught through brief didactic and semi-interactive videos followed by invitations and opportunities for practice within the session and at home. Participants will complete a baseline, mid-point, and post-intervention survey to determine the influence of the intervention.\n\nThere will be one follow-up survey with participants after the intervention. The survey will take place 1 month after the program has concluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents ages 14-19\n* Adolescents able to speak and understand English fluently\n* Adolescents with reliable internet access (for virtual access to online modules)\n\nExclusion Criteria:\n\n* Individuals younger than age 14 and older than age 19\n* Individuals who are not able to speak or understand English fluently\n* Individuals without reliable internet access'}, 'identificationModule': {'nctId': 'NCT04958694', 'acronym': 'CEDARS', 'briefTitle': 'CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents', 'orgStudyIdInfo': {'id': 'IRB 2021-4642'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CEDARS- Active Intervention', 'description': 'Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=20) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction.', 'interventionNames': ['Behavioral: CEDARS']}, {'type': 'OTHER', 'label': 'CEDARS- Waitlisted Control', 'description': 'The investigators will use a wait-listed control for the pilot intervention in adolescents (N=20) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction.', 'interventionNames': ['Behavioral: CEDARS']}], 'interventions': [{'name': 'CEDARS', 'type': 'BEHAVIORAL', 'description': 'This intervention is intended to help adolescents cope with stress and improve positive affect.', 'armGroupLabels': ['CEDARS- Active Intervention', 'CEDARS- Waitlisted Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Nia Heard-Garris, MD,MSc,FAAP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc, FAAP', 'investigatorFullName': 'Nia Heard-Garris', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}