NCT04712461

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

January 12, 2021

Last Update Submit

September 25, 2025

Conditions

Keywords

Mental Health

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (2)

  • Change in 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

    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).

Study Arms (2)

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.

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.

Interventions

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.

SUPPORTS Implementation Model

Eligibility Criteria

Age3 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Therapists employed at their current agency for less than 6 months.
  • Children less than 3 years old or older than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Teresa Lind, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Lind, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 15, 2021

Study Start

January 1, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations