Mental Health IssueSUPPORTSNCT04712461
Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs
A study testing SUPPORTS in people with Mental Health Issue, run by San Diego State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- SUPPORTS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Therapists who have delivered a (or components of a) trauma EBP to a child in the past year.
Who cannot join
- Therapists employed at their current agency for less than 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92123
Teresa Lind, 5082370631, tlind@sdsu.edu
About this study
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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- SUPPORTS
- Keywords
- Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPPORTSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SUPPORTS Implementation Model | Experimental | 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. Receives: Other: SUPPORTS |
| Implementation as Usual | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Secondary outcomes (1)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Jan 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Teresa Lind, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712461
- Sponsor's protocol ID
- IRB-25-0275
- Acronym
- SUPPORTS
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs
- ClinicalTrials.gov ID
- NCT04712461
- Acronym / sponsor ID
- SUPPORTS / IRB-25-0275
- Conditions
- Mental Health Issue
- Keywords
- Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUPPORTS Implementation Model | Experimental | Other: SUPPORTSThe 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. |
| Implementation as Usual | No intervention | –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. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Therapists who have delivered a (or components of a) trauma EBP to a child in the past year.
Key exclusion criteria (1 listed)
- Therapists employed at their current agency for less than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPPORTSThe 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. | Other | SUPPORTS Implementation Model |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teresa Lind, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUPPORTS in people with Mental Health Issue, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Lind, PhD (5082370631, tlind@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.