Burnout, ProfessionalNCT03303482

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

A study testing Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute) in people with Burnout, Professional, run by Temple University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Burnout, Professional
What is being tested?: Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteUnited States
Study dates: 19 Sep 2017to 21 May 2018
Phase: Interventional
Are there results?: None posted in the registry

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Temple University
Philadelphia, Pennsylvania, 01940

Other trials in United States

About this study

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.

Conditions: Burnout, Professional
Being tested: Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)
Medical subject headings: Burnout, Professional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)Behavioural
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.

Study groups in NCT03303482
Study group	Role	What they receive
Intervention Group	Experimental	Not described Receives: Behavioral: Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)
Waitlist Control Group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 attitudes about trauma-informed care (Attitudes Related to Trauma-Informed Care Scale) at 3 months
Measured: 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 burnout (Maslach Burnout Inventory General) at 3 months
Measured: 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 trust in relationships with parents, supervisors, and other staff members (adapted from Trust in Schools Instruments) at 3 months
Measured: 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 mentally and physically unhealthy days (CDC Health-Related Quality of Life Healthy Days Core Module) at 3 months
Measured: 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 quality and duration of nighttime sleep (Pittsburgh Sleep Quality Index) at 3 months
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 201721 May 2018

First posted6 Oct 2017
Study start19 Sep 2017
Primary completion21 May 2018
Study completion21 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Burnout, ProfessionalStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03303482
Sponsor's protocol ID: UW17246
Status last verified: Nov 2018
First submitted: 18 Sep 2017
Last updated: 20 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators
ClinicalTrials.gov ID: NCT03303482
Acronym / sponsor ID: UW17246
Conditions: Burnout, Professional
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Collaborators: United Way of Greater Philadelphia and Southern New Jersey (UWGPSNJ), Lakeside Global Institute, The School District of Philadelphia
Study start: 19 Sep 2017 (actual)
Primary completion: 21 May 2018 (actual)
Study completion: 21 May 2018 (actual)
First posted: 6 Oct 2017 (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.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Intervention Group	Experimental	Behavioral: Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)
Waitlist Control Group	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
Enhancing 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.	Behavioural	Intervention Group

Primary outcome

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

10 secondary outcomes

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
Derived from this study: PubMed 31026037Whitaker 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.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Robert Whitaker, MD, MPH principal investigator

Temple 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 Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute) in people with Burnout, Professional, run by Temple 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?

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: finished, as of the sponsor's last update on 20 Nov 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in teacher-children relationship quality (specifically, levels of perceived conflict) at 3 months (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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03303482, which also lists 1 linked publication.

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 20 Nov 2018.