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Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs (SUPPORTS)

Primary Purpose

Mental Health Issue

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SUPPORTS
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Issue focused on measuring Mental Health

Eligibility Criteria

3 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • San Diego State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SUPPORTS Implementation Model

Implementation as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Child Trauma Symptoms
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 12, 2021
Last Updated
April 24, 2023
Sponsor
San Diego State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04712461
Brief Title
Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs
Acronym
SUPPORTS
Official Title
Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue
Keywords
Mental Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SUPPORTS Implementation Model
Arm Type
Experimental
Arm Description
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.
Arm Title
Implementation as Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SUPPORTS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Child Trauma Symptoms
Description
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.
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).
Secondary Outcome Measure Information:
Title
Change in Therapist Burnout
Description
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.
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).
Title
Change in Therapist Turnover Intention
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Lind, PhD
Phone
5082370631
Email
tlind@sdsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Lind, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Lind
Phone
508-237-0631
Email
tlind@sdsu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs

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