- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03303482
A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Verenigde Staten, 01940
- Temple University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Interventie Groep
|
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.
|
Geen tussenkomst: Wachtlijst controlegroep
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in teacher-children relationship quality (specifically, levels of perceived conflict) at 3 months
Tijdsspanne: 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.
|
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).
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Change in mindfulness (Cognitive and Affective Mindfulness Scale-Revised) at 3 months
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
|
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).
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Robert Whitaker, MD, MPH, Temple University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UW17246
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Burn-out, professioneel
-
Center for Primary Care and Public Health (Unisante)...University of Lausanne Hospitals; Institut et Haute Ecole de la Santé la SourceWervingInformele verzorger | Medisch professionalZwitserland
-
Rush University Medical CenterVoltooidHigh-flow neuscanule | Transmissie, geduldige professionalVerenigde Staten
-
Institut de Cancérologie de la LoireVoltooidParamedische professionalFrankrijk
-
Göteborg UniversityOnbekendMentale gezondheidZweden
-
Gerencia de Atención Primaria, MadridFondo de Investigacion SanitariaVoltooid
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaVoltooid
-
Charite University, Berlin, GermanyKarl and Veronica Carstens Foundation; European Association for Ayurveda Therapists...VoltooidBurnout syndroomDuitsland
-
Luis A PerulaSociedad Andaluza de Medicina Familiar y ComunitariaVoltooid
-
Umeå UniversityVästerbotten County Council, Sweden; Swedish Social Insurance AgencyVoltooid
-
Services Hospital, LahoreVoltooidBurnout syndroomPakistan