Viewing Study NCT00164229



Ignite Creation Date: 2024-05-05 @ 11:53 AM
Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00164229
Status: COMPLETED
Last Update Posted: 2008-04-28
First Post: 2005-09-09

Brief Title: Fetal Alcohol Syndrome Socio-Cognitive Habilitation
Sponsor: Centers for Disease Control and Prevention
Organization: Centers for Disease Control and Prevention

Study Overview

Official Title: Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition
Status: COMPLETED
Status Verified Date: 2005-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Comprehensive evaluation geneticist psychologist social worker education specialist others as indicated to determine individual needs and treatment plan Referrals for specific services eg OT counseling medications etc will be to clinicians within the families own communities All families will receive evaluation parent educationadvocacy 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 childs arousal level to avoid negative episodes 2 recognizing their own arousal and how it contributes to a situation 3 principles of social reinforcement eg praise ignore etc 4 accidental teaching ie teaching when a situationopportunity arises 5 resourcesupport 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 EscapeNo Escape for undesirable tasks 2 arousal awareness and 3 verbalization of situations and actions eg I dont like it when mom yells at me for running in the house so I wont 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 HighScope 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 FASARND For teachers a manual will be prepared to assist them in working with children who have FASARND 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 eg parent satisfaction compliance etc and outcome eg math skill behavior family functioning etc measures will be evaluated

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U84ccu320162 None None None