NCT03303482

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 18, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 19, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

September 18, 2017

Last Update Submit

November 19, 2018

Conditions

Outcome Measures

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.

    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 (10)

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

    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).

  • Change in empathy (Interpersonal Reactivity Index) at 3 months

    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).

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

    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).

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

    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).

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

    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 more secondary outcomes

Study Arms (2)

Intervention Group

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

Waitlist Control Group

NO INTERVENTION

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 01940, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Robert Whitaker, MD, MPH

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The investigators will randomly assign consenting teachers by classroom (lead teacher and/or assistant teacher) to either the fall or spring course (intervention and waitlist control groups, respectively). The course will be taught to groups of 16 teachers, with four groups in the fall course (64 teachers) and four in the spring course (64 teachers). To determine the impacts of the training intervention on those assigned to the fall course (intervention groups), those assigned to the spring course (control groups) will serve as concurrent controls during the fall.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology and Biostatistics and Pediatrics

Study Record Dates

First Submitted

September 18, 2017

First Posted

October 6, 2017

Study Start

September 19, 2017

Primary Completion

May 21, 2018

Study Completion

May 21, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations