Fetal Alcohol SyndromePhase 1/2NCT00164229
Fetal Alcohol Syndrome: Socio-Cognitive Habilitation
A Phase 1/2 study testing math and behavior regulation in people with Fetal Alcohol Syndrome, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Comprehensive evaluation (geneticist, psychologist, social worker, education specialist, others as indicated) to determine individual needs and treatment plan. Referrals for specific services (e.g., OT, counseling, medications, etc) will be to clinicians within the families' own communities. Read more about this study
- Who is it for?
- Ages 42 to 81 monthsHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Syndrome
- What is being tested?
- math and behavior regulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Jan 2005
- Phase
- Phase 1/2
- 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 42 to 81 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- diagnosis of FAS or related condition
- age 3 years six month or older
Who cannot join
- age 6 years 9 months or older
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition
Comprehensive evaluation (geneticist, psychologist, social worker, education specialist, others as indicated) to determine individual needs and treatment plan. Referrals for specific services (e.g., OT, counseling, medications, etc) will be to clinicians within the families' own communities. All families will receive evaluation, parent education/advocacy, and learning readiness program. Only the intervention group will receive the math intervention.
Read the detailed description
Learning Readiness Program: This program will include: case management to secure needed services, medication consultation (psychiatrist), educational consultation/ liaison, Behavioral Regulation Training (BRT). BRT will include teaching parents about: 1) recognizing their child's arousal level (to avoid negative episodes), 2) recognizing their own arousal and how it contributes to a situation, 3) principles of social reinforcement (e.g., praise, ignore, etc), 4) "accidental teaching" (i.e., teaching when a situation/opportunity arises), 5) resource/support source identification, 6) to communicate choices rather than authoritative commands, and 6) reduction of repetitive prompts (nagging). The child will be taught: 1) the technique of Escape/No Escape for undesirable tasks, 2) arousal awareness, and 3) verbalization of situations and actions (e.g., I don't like it when mom yells at me for running in the house, so I won't run in the house).
Targeted Area of Intervention: MATH - 6 weeks of individualized math tutoring. Content of the tutoring will be tailored to age levels (either 3-6 yr olds or 6-9 yr olds). The High/Scope curriculum will be used (modified so that it can be individualized). In addition, visual materials and visual aids will be developed to address deficits in the visual-spatial skills of children with FAS/ARND. For teachers, a manual will be prepared to assist them in working with children who have FAS/ARND. The educational specialist will review the manual and techniques with each teacher involved with the child.
Parent component: Individual and small group sessions to include: FAS education, information on education system procedures, instruction for communicating with professionals, and support for advocating for their child. A caregiver manual will be prepared.
Evaluation Plan: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 6-month follow-up. Process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., math skill, behavior, family functioning, etc) measures will be evaluated.
- Conditions
- Fetal Alcohol Syndrome
- Being tested
- math, behavior regulation
- Keywords
- treatment, control
- 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.
mathBehavioural
behavior regulationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
math knowledge
math skills
Secondary outcomes (2)
behavior regulation
parent knowledge of FAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2001
- Study completionJan 2005
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
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Emory University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Marcus Institute
- Investigators
- claire coles, PhD, Principal investigator, Marcus Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164229
- Sponsor's protocol ID
- CDC-NCBDDD-3721
- Other IDs
- U84ccu320162
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 28 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition
- ClinicalTrials.gov ID
- NCT00164229
- Acronym / sponsor ID
- CDC-NCBDDD-3721
- Conditions
- Fetal Alcohol Syndrome
- Keywords
- treatment, control
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Emory University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Marcus Institute
- Study start
- Oct 2001
- Study completion
- Jan 2005
- First posted
- 14 Sep 2005 (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.
Comprehensive evaluation (geneticist, psychologist, social worker, education specialist, others as indicated) to determine individual needs and treatment plan. Referrals for specific services (e.g., OT, counseling, medications, etc) will be to clinicians within the families' own communities. All families will receive evaluation, parent education/advocacy, and learning readiness program. Only the intervention group will receive the math intervention.
Detailed description
Learning Readiness Program: This program will include: case management to secure needed services, medication consultation (psychiatrist), educational consultation/ liaison, Behavioral Regulation Training (BRT). BRT will include teaching parents about: 1) recognizing their child's arousal level (to avoid negative episodes), 2) recognizing their own arousal and how it contributes to a situation, 3) principles of social reinforcement (e.g., praise, ignore, etc), 4) "accidental teaching" (i.e., teaching when a situation/opportunity arises), 5) resource/support source identification, 6) to communicate choices rather than authoritative commands, and 6) reduction of repetitive prompts (nagging). The child will be taught: 1) the technique of Escape/No Escape for undesirable tasks, 2) arousal awareness, and 3) verbalization of situations and actions (e.g., I don't like it when mom yells at me for running in the house, so I won't run in the house).
Targeted Area of Intervention: MATH - 6 weeks of individualized math tutoring. Content of the tutoring will be tailored to age levels (either 3-6 yr olds or 6-9 yr olds). The High/Scope curriculum will be used (modified so that it can be individualized). In addition, visual materials and visual aids will be developed to address deficits in the visual-spatial skills of children with FAS/ARND. For teachers, a manual will be prepared to assist them in working with children who have FAS/ARND. The educational specialist will review the manual and techniques with each teacher involved with the child.
Parent component: Individual and small group sessions to include: FAS education, information on education system procedures, instruction for communicating with professionals, and support for advocating for their child. A caregiver manual will be prepared.
Evaluation Plan: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 6-month follow-up. Process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., math skill, behavior, family functioning, etc) measures will be evaluated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 42 to 81 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of FAS or related condition
- age 3 years six month or older
Key exclusion criteria (1 listed)
- age 6 years 9 months or older
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 |
|---|---|---|
| math | Behavioural | – |
| behavior regulation | Behavioural | – |
Primary outcome
math knowledge
math skills
2 secondary outcomes
behavior regulation
parent knowledge of FAS
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 28 Apr 2008.
Related trials for Fetal Alcohol Syndrome
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FASD Prevention R33
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Families Moving Forward (FMF) Connect Pro for Mental Health Providers
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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.
claire coles, PhD principal investigator
Marcus Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing math and behavior regulation in people with Fetal Alcohol Syndrome, run by Centers for Disease Control and Prevention 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 2 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 28 Apr 2008. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
math knowledge. The study lists 2 primary outcomes in all. 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 28 Apr 2008.