- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712461
Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs (SUPPORTS)
September 25, 2025 updated by: San Diego State University
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Teresa Lind, PhD
- Phone Number: 5082370631
- Email: tlind@sdsu.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Recruiting
- San Diego State University
-
Contact:
- Teresa Lind
- Phone Number: 508-237-0631
- Email: tlind@sdsu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Therapists who have delivered Trauma Focused Cognitive Behavioral Therapy (TF-CBT) in the past 6 months.
- Children aged 3-18 years old who is receiving TF-CBT from therapist enrolled in study.
Exclusion Criteria:
- Therapists employed at their current agency for less than 6 months.
- Children less than 3 years old or older than 18 years old.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SUPPORTS Implementation Model
The SUPPORTS implementation model will consist of a package of implementation strategies aimed at improving EBP sustainment through reducing provider burnout and turnover and improving organizational climate.
The content and structure of SUPPORTS will be informed by the occupational health literature (e.g., psychoeducation about burnout, mindfulness training, or changes involvement of providers in organizational decision-making) and from a needs and context assessment.
|
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.
|
|
No Intervention: Implementation as Usual
Agencies in the Implementation as Usual condition will have implementation strategies tied to the implementation of EBPs that these agencies in the community are already using (i.e., the study will measure the implementation strategies being used by the agency but will not provide any additional strategies).
There will be no strategies related to reducing provider burnout and turnover and improving organizational climate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Child Trauma Symptoms
Time Frame: The UCLA PTSD RI will be completed by the caregiver at baseline, and at 3- and 6-months follow-up assessments (3 and 6 month following pre-intervention/enrollment in study).
|
The University of California Los Angeles (UCLA) Posttraumatic Stress Disorder (PTSD) Reaction Index (RI) for Diagnostic and Statistical Manual 5 (DSM-5) questionnaire will be used to measure change in child trauma symptoms.
The UCLA PTSD RI screens for exposure to potentially traumatic events and provides an assessment of the intensity of Post-traumatic Stress Disorder (PTSD) symptoms.
The UCLA PTSD RI for DSM-5 is based on the DSM-5 criteria for PTSD and the items directly map onto criteria B (intrusions), C (avoidance), D (negative alterations in cognitions and mood) and E (hyperarousal).
Scores on the UCLA PTSD RI range from 0 to 80, with higher scores representing a greater intensity of child trauma symptoms.
|
The UCLA PTSD RI will be completed by the caregiver at baseline, and at 3- and 6-months follow-up assessments (3 and 6 month following pre-intervention/enrollment in study).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Therapist Burnout
Time Frame: 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/enrollment in study).
|
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/enrollment in study).
|
|
Change in Therapist Turnover Intention
Time Frame: 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/enrollment in study).
|
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/enrollment in study).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Teresa Lind, PhD, San Diego State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
January 12, 2021
First Submitted That Met QC Criteria
January 14, 2021
First Posted (Actual)
January 15, 2021
Study Record Updates
Last Update Posted (Estimated)
September 26, 2025
Last Update Submitted That Met QC Criteria
September 25, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-2021-0008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health Issue
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Stanford UniversityRecruitingMental Health IssueUnited States
-
The Hong Kong Polytechnic UniversityRecruiting
-
Yale UniversityEmpowerment to Heal - Uganda; Empower Through HealthRecruiting
-
The Hong Kong Polytechnic UniversityRecruiting
-
Hospices Civils de LyonCompleted
-
The Hong Kong Polytechnic UniversityCompleted
-
Limbic LimitedCompletedMental Health IssueUnited Kingdom
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...Completed
-
Wake Forest University Health SciencesThe Duke EndowmentCompletedMental Health IssueUnited States
Clinical Trials on SUPPORTS
-
University of ChicagoCompleted
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Mental Health (NIMH); Centers for Disease Control and... and other collaboratorsCompletedProblem BehaviorUnited States
-
Rush University Medical CenterThe UAW-GM National Joint Committee on Health & SafetyCompletedLow Back Pain
-
Massachusetts General HospitalCompletedLow Back Pain | Knee Pain | Morton Neuroma | Metatarsalgia | Ankle Pain | Plantar Fasciitis of Both Feet | Hallux Valgus DeformityUnited States
-
Children's Hospital Medical Center, CincinnatiUganda Heart InstituteCompletedRheumatic Heart Disease in Children | Heart Disease, ValvularUganda
-
Ann & Robert H Lurie Children's Hospital of ChicagoPatient-Centered Outcomes Research InstituteCompleted
-
Michigan State UniversityUniversity of MichiganCompleted
-
Uppsala UniversityThe Swedish Research CouncilRecruiting
-
University of PittsburghNational Institute on Aging (NIA)CompletedPhysician-Family Communication in Intensive Care Units | Surrogate Decision-making for Critically Ill Patients | Critically Ill Intensive Care Unit PatientsUnited States