Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT05386251
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2021-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The same providers will deliver both treatment arms and so it will be difficult to fully mask the providers to which group is active (based on their natures). However, participants will be told that both groups are active and outcomes assessors will not be informed about group membership.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Students are randomized in a 1:1 allocation ratio to the active treatment of the control group. Participants will be randomized to the strategies or peer support groups using a stratified randomization procedure that randomizes within grade level (i.e., middle school or high school). After 20 students are randomized to a group, the group will be scheduled to begin.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2021-09-24', 'studyFirstSubmitQcDate': '2022-05-17', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment Satisfaction', 'timeFrame': 'At Post-treatment, approximately 8 weeks after initial group session', 'description': 'Parent and Self Report Satisfaction Survey'}, {'measure': 'Treatment Fidelity', 'timeFrame': 'Through Treatment Completion, an average of 8 weeks', 'description': 'Blinded Observers will observe to code for fidelity'}, {'measure': 'Treatment Barriers', 'timeFrame': 'At Post-treatment, approximately 8 weeks after initial group session', 'description': 'Parent an Self Reported Barriers Survey'}, {'measure': 'Treatment Credibility', 'timeFrame': 'At Post-treatment, approximately 8 weeks after initial group session', 'description': 'Client Credibility Questionnaire-Parent and Self'}, {'measure': 'Video Conferencing Feasibility', 'timeFrame': 'At Post-treatment, approximately 8 weeks after initial group session', 'description': 'Video-Conferencing Questionnaire-Parent and Self'}, {'measure': 'Treatment Attendance', 'timeFrame': 'Through study completion, an average of 8 weeks, at each Session of Treatment', 'description': 'Group records'}, {'measure': 'Treatment Homework Completion', 'timeFrame': 'Through study completion, an average of 8 weeks, at each Session of Treatment', 'description': 'Group records'}], 'primaryOutcomes': [{'measure': 'ADHD Symptoms', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Parent and Self Ratings on the SNAP Rating Scale'}, {'measure': 'Academic Impairment: Grade Point Average', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Official School Records'}, {'measure': 'Academic Impairment: School Attendance', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Official School Records'}], 'secondaryOutcomes': [{'measure': 'Academic Motivation', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Expectancy-Value Questionnaire -Self Version'}, {'measure': 'Academic Motivation', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Change Ruler -Self Version'}, {'measure': 'Executive Functions', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'BRIEF Rating Scale -Parent Version'}, {'measure': 'Organization, Time Management, and Planning', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Adolescent Academic Problems Checklist-Parent and Self Version will be used to measure organization, time management and planning'}, {'measure': 'Parent Academic Involvement', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Parent Academic Management Scale - Parent Version'}, {'measure': 'Academic Impairment Rating Scale', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Impairment Rating Scale - Parent Version'}, {'measure': 'Parent-Teen Conflict', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Conflict Behavior Questionnaire-20 - Parent, Self Version'}, {'measure': 'Goal Setting', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Goal Setting Questionnaire- Parent and Self'}, {'measure': 'Parent Autonomy Support', 'timeFrame': 'Change from Baseline through 3 months after Post-Treatment, an average of 6 months', 'description': 'Parent Promotion of Volitional Functioning- Self Report'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADHD', 'Behavioral Intervention', 'Telehealth'], 'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effectiveness of a telehealth-delivered skills training versus active control group for middle and high school students with ADHD symptoms. Both programs will be delivered digitally (via Zoom).\n\nInvestigators will measure student functioning at baseline, post-group, and three-month follow-up. The primary outcomes are ADHD symptoms, student grade point average, and attendance as reported in the gradebook. Secondary outcomes include parent academic support, autonomy, academic motivation, and organization skills. Participant satisfaction with the group will be measured post-group. Group attendance and homework completion will also be measured.', 'detailedDescription': '120 middle and high school students with elevated ADHD symptoms will be recruited for this study, which will take place over the course of the 2021-2022 academic year. The recruitment strategy will be to distribute information about the study opportunity to educator email lists in South Florida (see appended email template). Educators will be instructed to share information about the study to the parents of students who perceive to experience ADHD symptoms in their schools, regardless of special education status or documentation of a disability.\n\nStudents who enroll will be randomly assigned to either receive the STAND-G strategy-based group or a peer-support-based, active control group. Investigators will blind participants and their parents to which group is the active treatment by informing parents and students that participant will be randomly assigned to one of two groups to help improve school difficulties in youth. The two groups will be of equal duration, both will be led by the same instructors; and will differ only in content (teaching strategies vs. facilitating peer support and problem-solving conversations).\n\nStudents (and their parents) will complete assessments at baseline, post-group, and three months post-group. School records will be obtained for all time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudents will be required to,\n\n* be in the sixth through twelfth grade,\n* have elevated ADHD symptoms\n* documented impairment according to the SNAP\n* documented impairment according to Impairment Rating Scale.\n* Students must be 17.5 or younger at the time of enrollment to ensure that they are still under 18 at the expected completion of the study.\n\nParents of eligible students will also participate.\n\nExclusion Criteria:\n\nStudents may not be,\n\n* in a self-contained special education classroom,\n* possess intellectual disability\n* be non-English speaking\n* be older than 18 years old at time of enrollment'}, 'identificationModule': {'nctId': 'NCT05386251', 'acronym': 'STAND-G', 'briefTitle': 'Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges', 'orgStudyIdInfo': {'id': '00003308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Parent Training/Organization Skills Training', 'description': 'Parents will receive 8 weeks of a 90 minute behavioral parent training protocol that focuses on supporting academic and behavioral success in adolescents with ADHD. Teens will receive a simultaneous 8 weeks of a 90 minute organization skills training group. Both groups will be delivered via telehealth.', 'interventionNames': ['Behavioral: BPT/OST']}, {'type': 'SHAM_COMPARATOR', 'label': 'Peer support', 'description': 'Parents and teens will each participate in 8 weeks of a 90 minute peer support group focused on exchange of shared experience and group problem-solving difficulties. Both groups will be delivered via telehealth.', 'interventionNames': ['Behavioral: Peer Support']}], 'interventions': [{'name': 'BPT/OST', 'type': 'BEHAVIORAL', 'otherNames': ['STAND-Group'], 'description': 'See Arm description.', 'armGroupLabels': ['Behavioral Parent Training/Organization Skills Training']}, {'name': 'Peer Support', 'type': 'BEHAVIORAL', 'description': 'See Arm description', 'armGroupLabels': ['Peer support']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Margaret Sibley, Ph.D.', 'role': 'CONTACT', 'email': 'margaret.sibley@seattlechildrens.org', 'phone': '206) 884-1424'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Within six months of the completion of the trial', 'ipdSharing': 'YES', 'description': 'We will submit data from this trial to the OSF data repository upon completion of the trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Margaret Sibley', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}