ClinicalTrials.gg
CompletedNCT03303482Updated Nov 20, 2018

A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators

An interventional study of Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute) in Burnout, Professional, sponsored by Temple University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-20.

Sponsored by Temple University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 96 studies in Burnout, Professional with a site in United States — 10 open to participants now, 16 under way, none of them phase 3. Burnout, Professional · United States.

Enrollment
36th of 89
96 · median 74
Started
2017
with 7 others
No phase
87 of 96
8 open now
Registered
15th of 96
by date

Among the 96 studies in Burnout, Professional with a site in United States, this one is the 36th largest by enrollment of the 89 interventional ones that give a count, is one of 8 that started in 2017, is one of 87 with no phase, and was the 15th registered.

Burnout, Professional

216 studies on the registry are indexed under Burnout, Professional; 33 are open to participants now.

Browse Burnout, Professional studies →

Open to participants now

10 of the 96 studies in Burnout, Professional with a site in United States are open now. Recruiting first, the newest first:

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All 10 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 14 Burnout, Professional studies recruiting now, 9 (64%) set no upper age limit and 5 (36%) stop at 75 or younger; 1 takes children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study summary

Background. To increase school readiness, Pre-K programs for low-income children must be responsive to the role of trauma in the lives of children, families, and staff. In 2017-2018, the School District of Philadelphia's (SDP) Office of Early Childhood Education will help Pre-K teachers support children's social-emotional and behavioral health, which is essential for early learning, by offering teachers a professional development course called Enhancing Trauma Awareness (ETA).

Purpose. To determine whether teachers who take ETA will have: 1) better work functioning; 2) more trusting work relationships; and 3) better health.

Population. Pre-K classroom teachers (n=128) working in centers under SDP auspice that serve exclusively low-income (≤300 % of poverty) children.

Intervention. A 12-week professional development course-Enhancing Trauma Awareness-will delivered by Lakeside Global Institute in 6 group sessions, with 16 teachers per group and each session lasting 2.5 hours.

Design. Consenting teachers will be randomly assigned by classroom (lead teacher and/or assistant teacher) to receive the ETA course in either fall 2017 (intervention groups) or spring 2018 (wait-list control groups).

Data collection and analysis. An external evaluation team (Temple University) will administer a confidential, online survey to all 128 teachers in fall 2017 (before fall course), winter 2017 (after fall course), and spring 2018 (after spring course). Teacher-children relationship quality will be the a priori primary outcome, and secondary outcomes will be assessed across the domains of work functioning, trust, and health.

03

Conditions studied

  • Burnout, Professional

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:Preschool classroom teacher who works in a center that is under the auspice of the School District of Philadelphia and serves exclusively low-income (≤300 % of poverty) children.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Behavioral: Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)

  • No intervention
    Waitlist Control Group

Interventions

  • BehavioralEnhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)

    The trauma awareness professional development course is delivered in a small group (up to 16 participants; 2.5 hours every other week over 12 weeks). The course provides an environment for professionals to explore in depth the complex nature of trauma, while also recognizing and emphasizing the highly sensitive nature of trauma that is essential to becoming trauma-informed. The course facilitates a heightened awareness and appreciation for trauma-related behaviors and consequences that influence relationships and systems and that persist across generations.

06

What researchers measure

Primary outcomes

  1. Change in teacher-children relationship quality (specifically, levels of perceived conflict) at 3 months

    A modified version of the Student-Teacher Relationship Scale (STRS) conflict subscale will be used to allow each teacher to provide one global or aggregated assessment of her/his relationships with all the children in the classroom. The conflict subscale includes eight items to assess negative, insecure, and hostile aspects of relationships.

    Time frame: The teacher-children relationship quality measurement will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

Secondary outcomes

  1. Change in mindfulness (Cognitive and Affective Mindfulness Scale-Revised) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  2. Change in empathy (Interpersonal Reactivity Index) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  3. Change in emotion regulation (Emotion Regulation Questionnaire) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  4. Change in compassion satisfaction (Professional Quality of Life Scale) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  5. Change in job satisfaction (adapted from Gallup Well-Being Work Index) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  6. Change in attitudes about trauma-informed care (Attitudes Related to Trauma-Informed Care Scale) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  7. Change in burnout (Maslach Burnout Inventory General) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  8. Change in trust in relationships with parents, supervisors, and other staff members (adapted from Trust in Schools Instruments) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  9. Change in mentally and physically unhealthy days (CDC Health-Related Quality of Life Healthy Days Core Module) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

  10. Change in quality and duration of nighttime sleep (Pittsburgh Sleep Quality Index) at 3 months

    Time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).

07

Study locations

1 site
  • Temple University
    Philadelphia, Pennsylvania 01940, United States
08

References and documents

Publications

  • Whitaker RC, Herman AN, Dearth-Wesley T, Smith HG, Burnim SB, Myers EL, Saunders AM, Kainz K. Effect of a Trauma-Awareness Course on Teachers' Perceptions of Conflict With Preschool-Aged Children From Low-Income Urban Households: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2019 Apr 5;2(4):e193193. doi: 10.1001/jamanetworkopen.2019.3193. PubMed 31026037 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in May 2018, 8 months.

Of 128 non-industry interventional studies with no phase under Burnout, Professional, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's 8 months is below that.

Counting every sponsor, half of 132 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2017
First posted
Oct 6, 2017
StartActual
Sep 19, 2017
Primary completionActual
May 21, 2018
CompletionActual
May 21, 2018
Last update
Nov 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03303482
Lead sponsor
Temple University
Collaborators
United Way of Greater Philadelphia and Southern New Jersey (UWGPSNJ), Lakeside Global Institute, The School District of Philadelphia
Responsible party
Robert Whitaker (Professor of Epidemiology and Biostatistics and Pediatrics, Temple University) — Principal investigator
First posted
Oct 6, 2017
Start date
Sep 19, 2017
Primary completion
May 21, 2018
Completion
May 21, 2018
Last update
Nov 20, 2018

Study contacts

Robert Whitaker, MD, MPH
principal investigator · Temple University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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