[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04712461":3,"trial-entities:NCT04712461":80,"trial-summary:NCT04712461":83},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":44,"minimum_age":45,"maximum_age":46,"healthy_volunteers":14,"eligibility_criteria":47,"std_ages":53,"locations":57,"central_contacts":72,"overall_officials":75,"references":78,"see_also_links":79},"NCT04712461","IRB-25-0275","Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs","RECRUITING","2027-05-01","2026-06","2026-06-08","2023-01-01","San Diego State University","OTHER",true,"The majority of children exposed to early adversity and trauma do not have access to sustainably delivered evidence-based mental health programs (EBPs), despite the growing prevalence of large-scale multiple-EBP implementation efforts aimed at increasing access to these services. The objective of this proposal is to develop and test a package of implementation strategies designed to promote the sustained delivery of child trauma EBPs by reducing provider turnover through targeting the associated mechanisms of provider burnout and organizational psychological safety climate. Findings will have a significant public health impact by informing efforts to increase the sustained availability of child trauma EBPs, thereby improving outcomes for children exposed to trauma.","Many evidence-based mental health interventions have been developed to address the negative outcomes associated with child exposure to early adversity and trauma. Despite these promising advances, however, the majority of children served in publicly funded mental health systems do not receive evidence-based programs (EBPs). To address this research-to-practice gap, several large-scale, system-driven implementation efforts of multiple trauma EBPs have been launched over the last decade, including in the states of California and Arkansas. Though these system-driven initiatives often increase EBP delivery in community settings following the initial implementation push, long-term sustainment of EBP delivery is low. Workforce risk factors, such as provider burnout leading to turnover, have been identified as contributing to the poor long-term sustainment of trauma EBPs. Therefore, an important step to consider in supporting the longterm sustainment of child trauma EBPs is to develop implementation strategies that target provider burnout and organizational climate factors associated with decreased provider retention. This study will develop and pilot a package of implementation strategies, \"Supporting Providers \\& Preventing the Overwhelming of Resources in Trauma Systems\" (SUPPORTS), aimed increasing the sustained delivery of trauma EBPs by addressing the factors associated with provider retention related to burnout. The development of SUPPORTS will be informed by a needs assessment conducted with programs involved with the multiple-EBP implementation efforts in California and Arkansas. A small randomized controlled pilot will then be conducted in California.",[18],"Mental Health Issue",[20],"Mental Health","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},60,"ESTIMATED",[29],{"type":13,"name":30,"description":31,"armGroupLabels":32},"SUPPORTS","The SUPPORTS implementation model will be developed and refined based on community feedback. It will likely include a combination of strategies demonstrated to reduce burnout and secondary traumatic stress in the occupational health literature, such as psychoeducation about burnout, mindfulness training, or changes in scheduling or the physical environment. As the most effective interventions have been shown to involve an integration of both individual- and organization-directed strategies supporting each other, SUPPORTS will aim to include both. For example, the model may include provider-directed strategies such as group peer consultation meetings, and organizational-directed strategies such as increasing communication and providers' involvement in organizational decisions. Through this approach, SUPPORTS will aim to target therapist burnout and turnover at the provider and organizational level.",[33],"SUPPORTS Implementation Model",[35],{"measure":36,"description":37,"timeFrame":38},"Change in Therapist Burnout","Change in therapist burnout with be assessed with the Maslach Burnout Inventory (MBI). The MBI consists of 16 items divided into three subscales (exhaustion, cynicism, and professional efficacy) that have been confirmed in factor analyses. Scores on the MBI range from 0 to 132, with higher scores representing greater levels of therapist burnout.","The MBI will be completed by the therapist at baseline, and at 3-, 6-, and 12-month follow-up assessments (3, 6, and 12 months following pre-intervention\u002Fenrollment in study).",[40],{"measure":41,"description":42,"timeFrame":43},"Change in Therapist Turnover Intention","Change in therapist turnover intention, or their intentions of either staying with or leaving a program will be measured with the 6-item Turnover Intention Scale (TIS-6). Scores on the TIS-6 range from 0 to 24, with higher scores indicating a greater intention to leave the organization.","The TIS-6 will be completed by the therapist at baseline, and at 3-, 6-, and 12-month follow-up assessments (3, 6, and 12 months following pre-intervention\u002Fenrollment in study).","ALL","3 Years","99 Years",{"inclusion":48,"exclusion":50,"raw_text":52},[49],"Therapists who have delivered a (or components of a) trauma EBP to a child in the past year.",[51],"Therapists employed at their current agency for less than 6 months.","Inclusion Criteria:\n\n* Therapists who have delivered a (or components of a) trauma EBP to a child in the past year.\n\nExclusion Criteria:\n\n* Therapists employed at their current agency for less than 6 months.",[54,55,56],"CHILD","ADULT","OLDER_ADULT",[58],{"facility":12,"status":7,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":69},"San Diego","California","92123","United States",[64],{"name":65,"role":66,"phone":67,"email":68},"Teresa Lind","CONTACT","5082370631","tlind@sdsu.edu",{"lat":70,"lon":71},32.71571,-117.16472,[73],{"name":74,"role":66,"phone":67,"email":68},"Teresa Lind, PhD",[76],{"name":74,"affiliation":12,"role":77},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":81,"biomarkers":82},[20],[],{"nct_id":4,"found":14,"summary":84,"prompt_version":94},{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is an interventional study planning to enroll 60 participants. It is not specified if it is randomized or blinded.","completed","Study to Reduce Burnout in Therapists Delivering Child Trauma Therapies","This study is testing a new approach called SUPPORTS to help therapists who deliver evidence-based mental health programs (EBPs) for children who have experienced trauma. Many children don't get these important services because therapists can experience burnout, leading to them leaving their jobs. The SUPPORTS model will include strategies like education about burnout and mindfulness to help therapists stay in their roles. The goal is to see if SUPPORTS can reduce therapist burnout, which would help more children get the care they need. Therapists who have delivered trauma EBPs to a child in the past year and have worked at their current agency for at least six months may be able to join. The study will measure changes in therapist burnout over 12 months.","Participants will be followed for 12 months after joining the study to measure changes in burnout.",124,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]