Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:20 AM
Study NCT ID:
NCT07471633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Piloting a Learning Collaborative for School-Based Bilingual Providers Delivering Evidence-Based Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All student participants will be assigned to participate in STRONG. All provider and leader participants will participate in the LC.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-14', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of LC - School Staff Ratings', 'timeFrame': 'Post Learning Collaborative (12 months from initial implementation)', 'description': 'To access feasibility of the LC, school mental health providers and school leaders will complete the Feasibility subscale from the Acceptability, Feasibility \\& Appropriateness measure. The response scale is 1 = not at all, 3 = moderately, 5 = extremely.'}, {'measure': 'Feasibility of LC - Attendance', 'timeFrame': 'During each Learning Collaborative learning session and consultation call (monthly during 12 month duration of Learning Collaborative)', 'description': 'Attendance records for LC learning sessions and consultation calls will be collected by the research team'}, {'measure': 'Feasibility of LC - Completion of PDSA cycles', 'timeFrame': 'During each Learning Collaborative learning session and consultation call (monthly during 12 month duration of Learning Collaborative)', 'description': 'Using meeting minutes from LC consultation calls and session surveys completed by facilitators, the research team will track the use of plan-do-study-act cycles by each school team and their progress to testing improvement ideas.'}, {'measure': 'Feasibility of LC - Barriers & Facilitators', 'timeFrame': 'Post Learning Collaborative (12 months from initial implementation)', 'description': "Guided by the Consolidated Framework for Implementation Research, providers and leaders' semi-structured individual interviews will ask about barriers and facilitators to participating in LC activities and delivering STRONG"}, {'measure': 'Acceptability of LC - Staff Ratings', 'timeFrame': 'Post Learning Collaborative (12 months from initial implementation)', 'description': 'To access acceptability of the LC, the STRONG facilitators and school leaders will complete the Acceptability (6-items) and Appropriateness (5-items) subscales from the Acceptability, Feasibility \\& Appropriateness measure . The response scale is 1 = not at all, 3 = moderately, 5 = extremely.'}, {'measure': 'Acceptability of LC - Staff Recommendation', 'timeFrame': 'Post Learning Collaborative (12 months from initial implementation)', 'description': 'School staff will rate their level of agreement with recommending the LC to others'}, {'measure': 'STRONG Fidelity', 'timeFrame': 'Each STRONG session (weekly for 10 weeks)', 'description': 'An observational coding system will be developed to measure STRONG fidelity and competence for each session, which will be audio recorded by facilitators.'}, {'measure': 'STRONG Adherence', 'timeFrame': 'Each STRONG session (weekly for 10 weeks)', 'description': 'The facilitator will be asked to complete self-adherence checklists for each session to assess their delivery of STRONG.'}], 'secondaryOutcomes': [{'measure': 'Youth Mental Health - SDQ', 'timeFrame': 'Baseline, Mid-treament (5 weeks), and Post-Treatment (after 10 weeks)', 'description': 'The Strengths \\& Difficulties Questionnaire (SDQ) will be completed by youth and their caregivers to assess youth mental health symptoms. The SDQ has four subscales: motional symptoms, conduct problems, hyperactivity/inattention problems, and peer problems and a 3-point Likert scale (0 = "Not at All" to 2 = "Certainly True"). Total sum scores (range=0-40) or externalizing (range 0=20; conduct and hyperactivity/inattention problems) or internalizing scores (range 0-20; Emotional problems and peer problems) can be calculated to assess clinical levels of symptoms.'}, {'measure': 'Youth Mental Health - YSR', 'timeFrame': 'Baseline and Post-Treatment (after 10 weeks)', 'description': 'The Youth Self Report (YSR) is a reliable and well-validated measure that contains a list of 118 behavior-problem items that the youth rates on a 3-point scale (not true = 0; sometime trues=1; very true=2). The YSR provides scores for internalizing and externalizing categories as well as DSM-oriented scales for anxious/depressed, depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior \\& aggressive behavior.'}, {'measure': 'Youth Mental Health - CBCL', 'timeFrame': 'Baseline and Post-Treatment (after 10 weeks)', 'description': 'The Child Behavior Checklist (CBCL) Parent Report Form is a reliable and well-validated measure contains a list of 118 behavior-problem items that the parent rates on a 3-point scale (not true = 0; sometime trues=1; very true=2). The CBCL provides scores for internalizing and externalizing categories as well as DSM-oriented scales for anxious/depressed, depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour \\& aggressive behaviour.'}, {'measure': 'Connor Davidson Resilience Scale', 'timeFrame': 'Baseline and Post-Treatment (after 10 weeks)', 'description': 'The Connor-Davidson Resilience Scale measures youth adaptability and resilience using 25 items. Participants respond on a 5-point Likert scale (0= "Not True at All" to 4 = "True Nearly All of Time"). Total scores are calculated (range = 0 to 100), and higher scores indicate more resilience. This will only be collected from youth.'}, {'measure': 'School Connectedness Scale', 'timeFrame': 'Baseline and Post-Treatment (after 10 weeks)', 'description': 'The School Connectedness Scale measures school bond as reported by youth using 5 items. Items are measured on a 5-point Likert agreement scale (1="Strong Disagree" to 5="Strongly Agree"). Mean scores are calculated and higher scores indicating higher school bond.'}, {'measure': 'Responses to Stress Questionnaire', 'timeFrame': 'Baseline and Post-Treatment (after 10 weeks)', 'description': 'The Responses to Stress Questionnaire is a 57-item measure of coping factors. The response scale is a 4-point Likert scale (1= "Not at all" to 4 = "A lot"). Mean scores are calculated with higher mean scores indicating higher coping in each coping factor. This will be collected for youth caregivers only'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implementation strategies', 'youth mental health', 'schools'], 'conditions': ['Acculturative Stress', 'Mental Health']}, 'descriptionModule': {'briefSummary': 'This pilot feasibility trial is designed to evaluate an adapted Learning Collaborative (LC) as an implementation strategy to support delivery of the Supporting Transition Resilience of Newcomer Groups (STRONG) intervention in school settings serving newcomer youth. The LC will support bilingual school-based mental health providers delivering STRONG, a group-based, school-delivered behavioral intervention targeting stress, anxiety, depressive symptoms, and externalizing behaviors among newcomer middle school students. STRONG will be facilitated by bilingual providers with participating students and their caregivers completing pre- and post-intervention surveys assessing youth emotional and behavioral well-being. The primary aim is to assess the feasibility, acceptability, and appropriateness of the LC for supporting school-based implementation of STRONG, with feasibility measured by participation in LC activities and completion of implementation supports, and acceptability and appropriateness assessed through provider and leader feedback. Secondary aims include examining whether provider and school leader engagement in LC activities is associated with STRONG implementation fidelity and youth outcomes, and exploring potential mechanisms linking LC engagement to fidelity, including provider self-efficacy, leadership support, and team psychological safety. School-based providers and school leaders (e.g., principals and superintendents) will participate in LC activities focused on shared learning, collaboration, and implementation problem-solving, along with ongoing supports such as structured team support calls, Plan-Do-Study-Act (PDSA) cycles, and feedback forms during STRONG implementation cycles.', 'detailedDescription': 'Bilingual providers play a critical role in increasing access to mental health care, yet there is a dearth of literature on bilingual provider training needs when delivering evidence-based interventions, especially to youth, and even less research on school-based interventions delivered in Spanish. One group with high mental health needs that relies on bilingual providers is newcomer youth, who have migrated to the U.S. within the past 5 years. Despite this high need, very few interventions have been developed for newcomers. One exception is Supporting Transition Resilience of Newcomer Groups (STRONG), a group-based, school-delivered behavioral intervention targeting stress, anxiety, depressive symptoms, and externalizing behaviors among newcomer youth. To date, however, interventions like STRONG remain underutilized in schools due to barriers like low leader support and poor provider fit. To maximize the public health impact of interventions delivered to Spanish-speaking youth, strategies that enhance bilingual provider training are needed.\n\nLearning Collaboratives (LC) are a promising implementation strategy that can strengthen intervention fit with schools and foster collective learning for bilingual providers. LCs involve recurring sessions with faculty experts, organization leaders, and providers who engage in Plan-Do-Study-Act (PDSA) cycles to overcome implementation challenges, and extant studies show LCs can positively influence provider fidelity and intervention sustainment. The LC in this study will aim to enhance the implementation of STRONG in schools for newcomer youth facilitated by bilingual providers. This study will be guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) and Consolidated Framework for Implementation Research (CFIR) frameworks and builds upon a completed Exploration phase with school district partners, where STRONG was chosen as the intervention to be adopted.\n\nThis study will recruit approximately 72 newcomer youth (ages 10-18) and their caregivers, 18 school mental health providers, and 9 school leaders, across four school districts and one county-level program. All youth will be receiving the STRONG intervention in their respective schools, delivered by school mental health providers and school staff familiar with the newcomer student experience, and all school provider/school leaders will take part in the LC.\n\nSTRONG is a 10-week intervention, consisting of 10 small group sessions, one individual session, and teacher and parent education sessions. STRONG is strengths based, teaches newcomers coping skills, draws from cognitive behavioral therapy, and helps foster positive identity and facilitate social connectedness among newcomers. School providers will participate in a 2-day in-person STRONG training led by a national expert and will have access to up to 4 hours of consultation with a STRONG national expert during their first time implementing STRONG. Providers will implement STRONG in two cycles, and data will be collected for each STRONG implementation cycle. Providers and school leaders will be asked to complete pre- \\& post- surveys and an interview. Providers will also be asked to audio record the STRONG sessions so the research team can measure their fidelity to the STRONG model. To assess clinical outcomes, youth and their caregivers will be completing measures of mental health symptoms, coping and resilience, and social connectedness, at pre- \\& post-STRONG.\n\nSchool staff will participate in the LC over the span of 12 months (anticipated February 2026-February 2027). LC activities include in-person Peer Learning Workshops (formally "Learning Sessions;" anticipated in February 2026, September 2026, \\& February 2027), and Team Support Calls (formally"Collaboration Calls;" frequency contingent on school leader and provider recommendations). The Peer Learning Workshops will focus on shared learning, collaboration, and implementation problem-solving related to STRONG delivery. Ongoing LC supports will include structured team support calls, PDSA cycles, and written feedback forms during STRONG implementation cycles. These activities are designed to support continuous quality improvement, address barriers to implementation, and strengthen teamwork and leadership engagement. Quantitative and qualitative data will be integrated to evaluate implementation processes and outcomes and to inform future scaling of STRONG in school settings serving newcomer youth. At least one provider from each STRONG facilitation team will be asked to complete weekly feedback forms during each STRONG cycle (i.e., 10 feedback forms per STRONG implementation cycle). To prevent additional burden on school staff to provide evaluation data, the Peer Learning Workshops and Team Support Calls will be recorded in order to track implementation challenges, proposed solutions and the outcomes of attempting the proposed solutions. Providers will receive compensation for submitting the STRONG audio recording and the weekly feedback forms\n\nFor the Primary Aim, this study will use a simultaneous mixed method QUAL+quant design using post-surveys and interviews to assess provider and leader perspectives on acceptability, feasibility and appropriateness of LC activities. Learning sessions will be audio recorded, and meeting minutes will be reviewed. Providers will complete various scales to assess leadership support of the LC, school commitment to the LC, and their level of agreement with recommending the LC to others. When the LC concludes, providers and leaders\' semi-structured individual interviews will ask about barriers and facilitators to participating in LC activities and delivering STRONG. For qualitative analyses, we will apply Rapid Qualitative Analysis (RQA) to characterize feasibility including barriers and facilitators to LC engagement and implementation. RQA was created for implementation research to quickly leverage findings to tailor implementation strategies and inform practice.\n\nFor the secondary aim, we will use pre-post surveys with school leaders, school providers, parents and newcomers to evaluate the effectiveness of LC and STRONG. Feasibility is operationalized as attendance in LC learning sessions, number of PDSA cycles, completion of monthly PDSA reports, progress on PDSA goals, and barriers/facilitators to participating in the LC. Providers will complete monthly reports via Qualtrics to collect STRONG implementation metrics (e.g., student attendance), and PDSA data. We hypothesize that higher engagement in LC activities will be positively related to stronger fidelity and greater improvement in clinical outcomes. Fidelity will be measured with an observational coding system developed by the research team to measure STRONG adherence and competence. We will also have self-adherence checklists completed by a STRONG facilitator at each session. To assess clinical outcomes, Youth and caregivers will complete standardized clinical symptom measures for both internalizing and externalizing disorders at pre- and post- surveys.\n\nPurposeful sampling strategies will be used to recruit school staff and caregivers from an established network of school district partners, including school district leaders and providers. Our network of school district partners will help identify potential school staff participants - specifically, leaders, and providers to participate in the interviews. School district partners will not be engaged in research activities. Specifically, they will not obtain informed consent, discuss the research study, or collect any data related to the study. Their sole role will be to identify potential school staff and parent/caregivers and obtain their permission to provide the research team with their contact information. Any questions from potential participants will be redirected to the research team. Research team members will follow up directly with the potential participants to explain the study, review informed consent, and screen for eligibility. For parents/caregivers of newcomer students, school staff will be asked to identify parents of newcomers (aged 10-17) and gain their permission for the research team to contact them regarding the research study. When parents/caregivers provide permission to be contacted by research personnel, school staff will message caregiver contact information to the research team. For newcomer students, the research team will complete an informed assent process with students who are eligible and invited to participate in the STRONG intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSchool Leader Eligibility:\n\n* (a) over 18 years old;\n* (b) district-level or school-level staff who manage and oversee operations and may have some decision-making power; district examples are superintendents and directors, and school examples are principals, vice principals, and directors.\n\nSchool Providers Eligibility:\n\n* (a) over 18 years old;\n* (b) mental health clinicians or school staff who regularly interact with newcomer students;\n* (c) bilingual in Spanish/English. It is important to note that at least one mental health clinician must facilitate STRONG but the co-facilitator can either be another clinician or a school staff who regularly interacts with newcomer students; example of such a school staff include English Language Development Teachers, interpreters, and equity coordinators\n\nStudent Eligibility:\n\n* (a) newcomer status (students who have migrated to a new country)\n* (b) 6th-12th grade\n* c) speaks Spanish/English/Mam\n* (d) elevated levels of mental health symptoms and/or functional impairment\n\nCaregiver Eligibility:\n\n* (a) over 18 years old;\n* (b) primary caregiver (e.g., biological parent; older sibling) of a newcomer student aged 10-17 who is participating in STRONG;\n* (c) able to speak in English, Spanish or Mam.\n\nExclusion Criteria:\n\n\\- For Students: Born in mainland United States'}, 'identificationModule': {'nctId': 'NCT07471633', 'acronym': 'SABER', 'briefTitle': 'Piloting a Learning Collaborative for School-Based Bilingual Providers Delivering Evidence-Based Interventions', 'organization': {'class': 'OTHER', 'fullName': 'University of Oregon'}, 'officialTitle': 'Piloting a Learning Collaborative for School-Based Bilingual Providers Delivering Evidence-Based Interventions', 'orgStudyIdInfo': {'id': 'STUDY00002199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Learning Collaborative + STRONG', 'description': 'A 12-month Learning Collaborative (LC) will be assigned to schools leaders/staff to help support the implementation of the STRONG intervention in schools. A LC helps systems implement effective interventions to improve the quality of care offered. Teams implementing STRONG and school leaders will meet often to learn about topics relevant to STRONG/newcomers and collaboratively solve challenges that arise when implementing STRONG. The LC consists of in person Peer Learning Workshop where participants will hear a presentation on a topic relevant to STRONG/newcomers and discuss their progress in implementing STRONG. The LC will also include Team Support Calls with all teams delivering STRONG on a regular basis. School leaders and school mental health providers will be participating in the LC, and school mental health providers will be administering the STRONG intervention to newcomer youth.', 'interventionNames': ['Behavioral: STRONG', 'Behavioral: Learning Collaborative']}], 'interventions': [{'name': 'STRONG', 'type': 'BEHAVIORAL', 'description': 'Supporting Transition Resilience of Newcomer Groups (STRONG) is a school-based group intervention for anxiety, depression, and externalizing symptoms in newcomer youth. STRONG is an evidence-based treatment and has been translated in 6 languages. Newcomer youth will be receiving the STRONG intervention, which will be administered by school mental health providers. STRONG is a 10-week intervention, with one individual session with each newcomer student, a caregiver/parent session, and a teacher session if available. STRONG is strengths based, teaches newcomers coping skills, draws from cognitive behavioral therapy and because it is a group intervention, it helps facilitate social connectedness among newcomers.', 'armGroupLabels': ['Learning Collaborative + STRONG']}, {'name': 'Learning Collaborative', 'type': 'BEHAVIORAL', 'description': 'A 12-month Learning Collaborative (LC) will be assigned to schools leaders/staff to help support the implementation of the STRONG intervention in schools. A LC helps systems implement effective interventions to improve the quality of care offered. Teams implementing STRONG and school leaders will meet often to learn about topics relevant to STRONG/newcomers and collaboratively solve challenges that arise when implementing STRONG. The LC consists of in person Peer Learning Workshop where participants will hear a presentation on a topic relevant to STRONG/newcomers and discuss their progress in implementing STRONG. The LC will also include Team Support Calls with all teams delivering STRONG on a regular basis. School leaders and school mental health providers will be participating in the LC.', 'armGroupLabels': ['Learning Collaborative + STRONG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97408', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'contacts': [{'name': 'Blanche Wright, PhD', 'role': 'CONTACT', 'email': 'bwright1@uoregon.edu', 'phone': '5413464831'}], 'facility': 'University of Oregon', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'centralContacts': [{'name': 'Blanche Wright, PhD', 'role': 'CONTACT', 'email': 'bwright1@uoregon.edu', 'phone': '541-346-4911'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oregon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Blanche Wright', 'investigatorAffiliation': 'University of Oregon'}}}}