TraumaNCT05261451
Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start
A study testing Workshop in people with Trauma, run by Loma Linda University at 1 site in United States.
Trial summary
This study will utilize a pre/post mix method design Quantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops. Qualitative data will be obtained through interviews post- workshop and consultations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma
- What is being tested?
- Workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 18 Apr 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Home Visitors or Teaching Staff at Head Start within San Bernardino County
- Between 18-65 years of age
- All genders
- English Speaking
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start
This study will utilize a pre/post mix method design
Quantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops.
Qualitative data will be obtained through interviews post- workshop and consultations.
- Conditions
- Trauma
- Being tested
- Workshop
- Keywords
- occupational therapy, trauma informed care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkshopOther
Participants will engage in three 1 hour workshops about trauma informed care. They will complete pre and post measure before engaging in the workshops
| Study group | Role | What they receive |
|---|---|---|
| Head Start Teachers | Experimental | Participants will engage in three 1- hour workshops and optional consultations with an occupational therapist Receives: Other: Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Survey
knowledge and experience
knowledge and experiences gained related to early childhood trauma. Higher scores indicate greater knowledge
Measured: Within 1 week after the consultations
Secondary outcomes (1)
Interview
Post interviews will be completed with participants who also complete the consultations
Measured: Within 2 weeks after the consultations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start14 Feb 2022
- Primary completion28 Mar 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arezou Salamat, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261451
- Sponsor's protocol ID
- 5210415
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start
- ClinicalTrials.gov ID
- NCT05261451
- Acronym / sponsor ID
- 5210415
- Conditions
- Trauma
- Keywords
- occupational therapy, trauma informed care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 2 Mar 2022 (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.
This study will utilize a pre/post mix method design
Quantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops.
Qualitative data will be obtained through interviews post- workshop and consultations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head Start Teachers | Experimental | Other: WorkshopParticipants will engage in three 1- hour workshops and optional consultations with an occupational therapist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Home Visitors or Teaching Staff at Head Start within San Bernardino County
- Between 18-65 years of age
- All genders
- English Speaking
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| WorkshopParticipants will engage in three 1 hour workshops about trauma informed care. They will complete pre and post measure before engaging in the workshops | Other | Head Start Teachers |
Primary outcome
Post-Survey
Time frame: Within 1 week after the consultations
knowledge and experience knowledge and experiences gained related to early childhood trauma. Higher scores indicate greater knowledge
1 secondary outcome
Interview
Time frame: Within 2 weeks after the consultations
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 1 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workshop in people with Trauma, run by Loma Linda 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?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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 1 Sep 2022. 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?
Post-Survey (time frame: Within 1 week after the consultations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2022.