Developmental DelayNCT01975506
Occupational Therapy in the Context of Head Start
An observational study of Developmental Delay, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of this study is to identify the role of occupational therapy within Head Start programs. Representatives within Head Start will be asked to participate in a nationwide internet based survey identifying the amount and type of services provided within this area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Developmental Delay
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Nov 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals within Head Start programs nationwide will be contacted to participate in an online survey about the use/role of occupational therapy in Head Start. Particapants will be recruited to participate in the study based upon their association with Head Start organizations across the United States. An initial e-mail will be sent to each individual informing them of the purpose of the study, and inviting them to participate in the survey. A link to the survey along with specific instructions in how to complete it will be included in the email. See attached email recruitment script. The age range is from 18 and up because a variety of disciplines may be selected to respond to the survey. Participants under the age of 18 are typically still in school and therefore may lack the exposure and understanding of occupational therapy services and the role of the occupational therapist within the Head Start program.
Who may be able to join
- Head Start program does not discriminate against gender, so every individual over the age of 18 who works within Head Start programs will be included in this study.
Who cannot join
- Although participants will not be excluded from the study based on ethnicity, non-English speaking individuals will be excluded from this study. Study materials will be presented in English only.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Examination of Occupational Therapy in the Context of Head Start
The purpose of this study is to identify the role of occupational therapy within Head Start programs. Representatives within Head Start will be asked to participate in a nationwide internet based survey identifying the amount and type of services provided within this area. The Model of Human Occupation (MOHO) will also be included in the study by identifying current use of the model and how it can be utilized in the future. In order to complete this study to the fullest extent, we must begin by defining the Model of Human Occupation as well as understanding the mission of the National Head Start Association. The vision of MOHO is to support practice that is focused on occupation, client centered, holistic, evidence-based, and complementary to other occupational therapy models. The mission of the National Head Start Association is to coalesce, inspire and support the Head Start field as a leader in early childhood development and education. This has lead researchers to perform the following study: An examination of occupational therapy in the context of Head Start.
Read the detailed description
Participants will be informed of the intent of the study in the initial e-mail introduction and invitation of participation. Participants will be given the opportunity to ask questions about the study by asking the research assistants, whose names and email addresses will be given. Within the initial email introduction/invitation of participation, participants will be given the name and contact information of the research assistants and will be instructed to direct all questions regarding the survey to them. All data received from the survey participants will be returned de-identified. None of the data collected will be traceable to the survey participants. Participants will be provided the research assistants' email addresses and can contact them should they be interested in receiving any results from the study. The benefits of the study are to advance the overall role of Occupational Therapy services within head start facilities. This study could further understandings of how and / or why certain concepts should / shouldn't be used, could assist administrators in developing quality programming, and contribute to the body of knowledge in Occupational Therapy in Head Start programs. The research assistants' e-mail addresses will be provided in the consent forms with a statement saying that they will be able to contact her via e-mail should they be interested in receiving any results from the study.Informed consent will be obtained through the initial email introduction and formal request for participation. Participants will be provided study information on the first page of the survey and will indicate their consent by clicking "yes" or "no" before beginning the survey.
- Conditions
- Developmental Delay
- Keywords
- Head Start, Occupational Therapy
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| head start practitioners | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Model of Human Occupation(MOHO)Web Based survey
E-mail will be the primary means of completing this study. Invitation for participation, survey instructions, and survey will all be completed through e-mail.The study will be conducted via the internet through a web based survey program.
Measured: The time commitment for participants will be approximately 15-20 minutes or however long it takes them to complete the online survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Bowyer, EdD,MS,OTR, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975506
- Sponsor's protocol ID
- 16898
- Status last verified
- Oct 2017
- First submitted
- 29 Jul 2013
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Occupational Therapy in the Context of Head Start
- ClinicalTrials.gov ID
- NCT01975506
- Acronym / sponsor ID
- 16898
- Conditions
- Developmental Delay
- Keywords
- Head Start, Occupational Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Nov 2013 (estimated)
- 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.
The purpose of this study is to identify the role of occupational therapy within Head Start programs. Representatives within Head Start will be asked to participate in a nationwide internet based survey identifying the amount and type of services provided within this area. The Model of Human Occupation (MOHO) will also be included in the study by identifying current use of the model and how it can be utilized in the future. In order to complete this study to the fullest extent, we must begin by defining the Model of Human Occupation as well as understanding the mission of the National Head Start Association. The vision of MOHO is to support practice that is focused on occupation, client centered, holistic, evidence-based, and complementary to other occupational therapy models. The mission of the National Head Start Association is to coalesce, inspire and support the Head Start field as a leader in early childhood development and education. This has lead researchers to perform the following study: An examination of occupational therapy in the context of Head Start.
Detailed description
Participants will be informed of the intent of the study in the initial e-mail introduction and invitation of participation. Participants will be given the opportunity to ask questions about the study by asking the research assistants, whose names and email addresses will be given. Within the initial email introduction/invitation of participation, participants will be given the name and contact information of the research assistants and will be instructed to direct all questions regarding the survey to them. All data received from the survey participants will be returned de-identified. None of the data collected will be traceable to the survey participants. Participants will be provided the research assistants' email addresses and can contact them should they be interested in receiving any results from the study. The benefits of the study are to advance the overall role of Occupational Therapy services within head start facilities. This study could further understandings of how and / or why certain concepts should / shouldn't be used, could assist administrators in developing quality programming, and contribute to the body of knowledge in Occupational Therapy in Head Start programs. The research assistants' e-mail addresses will be provided in the consent forms with a statement saying that they will be able to contact her via e-mail should they be interested in receiving any results from the study.Informed consent will be obtained through the initial email introduction and formal request for participation. Participants will be provided study information on the first page of the survey and will indicate their consent by clicking "yes" or "no" before beginning the survey.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head start practitioners | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals within Head Start programs nationwide will be contacted to participate in an online survey about the use/role of occupational therapy in Head Start. Particapants will be recruited to participate in the study based upon their association with Head Start organizations across the United States. An initial e-mail will be sent to each individual informing them of the purpose of the study, and inviting them to participate in the survey. A link to the survey along with specific instructions in how to complete it will be included in the email. See attached email recruitment script. The age range is from 18 and up because a variety of disciplines may be selected to respond to the survey. Participants under the age of 18 are typically still in school and therefore may lack the exposure and understanding of occupational therapy services and the role of the occupational therapist within the Head Start program.
Key inclusion criteria (1 listed)
- Head Start program does not discriminate against gender, so every individual over the age of 18 who works within Head Start programs will be included in this study.
Key exclusion criteria (1 listed)
- Although participants will not be excluded from the study based on ethnicity, non-English speaking individuals will be excluded from this study. Study materials will be presented in English only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Model of Human Occupation(MOHO)Web Based survey
Time frame: The time commitment for participants will be approximately 15-20 minutes or however long it takes them to complete the online survey
E-mail will be the primary means of completing this study. Invitation for participation, survey instructions, and survey will all be completed through e-mail.The study will be conducted via the internet through a web based survey program.
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 13 Oct 2017.
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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.
Patricia Bowyer, EdD,MS,OTR principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Delay, run by Texas Woman's 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 1 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 13 Oct 2017. 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?
The Model of Human Occupation(MOHO)Web Based survey (time frame: The time commitment for participants will be approximately 15-20 minutes or however long it takes them to complete the online survey). 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 13 Oct 2017.