Fetal Alcohol SyndromeEarly Phase 1NCT00747630
Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS)
A Early Phase 1 study testing An educational video about Fetal Alcohol Syndrome in people with Fetal Alcohol Syndrome and Teen Pregnancy, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Evaluating the efficacy of a video about FAS to determine whether it has an impact on knowledge about FAS and their likelihood to participate in risk taking behavior. Read more about this study
- Who is it for?
- Ages 12 to 16 years, women only
- Conditions the study is for
- Fetal Alcohol Syndrome, Teen Pregnancy
- What is being tested?
- An educational video about Fetal Alcohol Syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2010
- Phase
- Early Phase 1
- 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 12 to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Pregnant teens aged 12 to 16 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome
Evaluating the efficacy of a video about FAS to determine whether it has an impact on knowledge about FAS and their likelihood to participate in risk taking behavior.
Read the detailed description
Teenage mothers are asked to participate in the study and then randomized into an intervention or control group. Both groups take a multiple choice survey and then are randomized to either watch a video about FAS or not. After the video (or not for the controls) they then take a post video short answer survey. The survey results are then scored and statistical analysis performed to determine whether the video intervention increased their knowledge about FAS and their likelihood to drink alcohol during pregnancy.
- Conditions
- Fetal Alcohol Syndrome, Teen Pregnancy
- Being tested
- An educational video about Fetal Alcohol Syndrome
- Keywords
- Fetal Alcohol Syndrome, Teen pregnancy
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An educational video about Fetal Alcohol SyndromeOther
A 20 minute video about FAS
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The group selected to watch the video. Receives: Other: An educational video about Fetal Alcohol Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether an educational video on FAS increases maternal knowledge on the subject and affects their likelihood to drink alcohol.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startMay 2006
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: This project was not a clinical trial requiring registration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol SyndromeStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tammy Camp, MD, Principal investigator, Texas Tech Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747630
- Sponsor's protocol ID
- FAS Study
- Status last verified
- Dec 2012
- First submitted
- 4 Sep 2008
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome
- ClinicalTrials.gov ID
- NCT00747630
- Acronym / sponsor ID
- FAS Study
- Conditions
- Fetal Alcohol Syndrome, Teen Pregnancy
- Keywords
- Fetal Alcohol Syndrome, Teen pregnancy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This project was not a clinical trial requiring registration
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Sep 2008 (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.
Evaluating the efficacy of a video about FAS to determine whether it has an impact on knowledge about FAS and their likelihood to participate in risk taking behavior.
Detailed description
Teenage mothers are asked to participate in the study and then randomized into an intervention or control group. Both groups take a multiple choice survey and then are randomized to either watch a video about FAS or not. After the video (or not for the controls) they then take a post video short answer survey. The survey results are then scored and statistical analysis performed to determine whether the video intervention increased their knowledge about FAS and their likelihood to drink alcohol during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: An educational video about Fetal Alcohol SyndromeThe group selected to watch the video. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pregnant teens aged 12 to 16 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| An educational video about Fetal Alcohol SyndromeA 20 minute video about FAS | Other | Intervention |
Primary outcome
To determine whether an educational video on FAS increases maternal knowledge on the subject and affects their likelihood to drink alcohol.
Time frame: Immediate
Results and safety
The study was stopped early (reason given: This project was not a clinical trial requiring registration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Tammy Camp, MD principal investigator
Texas Tech Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing An educational video about Fetal Alcohol Syndrome in people with Fetal Alcohol Syndrome and Teen Pregnancy, run by Texas Tech University Health Sciences Center 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 0 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: stopped early, as of the sponsor's last update on 17 Dec 2012. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This project was not a clinical trial requiring registration). Results are not available in the source record.
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?
To determine whether an educational video on FAS increases maternal knowledge on the subject and affects their likelihood to drink alcohol. (time frame: Immediate). 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 17 Dec 2012.