Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164554
Status:
COMPLETED
Last Update Posted:
2008-04-28
First Post:
2005-09-12
Brief Title:
Fetal Alcohol SyndromeARND Research Consortion
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Fetal Alcohol SyndromeARND Research Consortion-Oklahoma
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:
Children will receive comprehensive evaluations through the UOHSC ABC program The assessment for the child will include medical issues including medication dysmorphic examination intellectual assessment academic achievement language and motor skills This program will provide appropriate non-study services and referrals Eligible families will be randomly assigned to treatment group or control group Treatment group will receive Parent Child Interaction Therapy PCIT The Control group will receive standard referrals and services through the ABC program and the parent educationadvocacy component of the project
Detailed Description:
PCIT has been adapted by the applicant for group administration The intervention will consist of 90-minute sessions of PCIT once a week for 14 weeks During PCIT sessions parents and children will participate in activities that promote interactions A behavior specialist who will be observing through a two-way mirror assists parents in development of appropriate behaviors and interaction techniques Parents will be prompted by use of in-ear devices ie bug in the ear This intervention has been shown to be effective in other populations For each family individualized goals for parent-child interactions will be set and reviewed each session Homework assignments also will be given
Parent Component Three 90-minute sessions conducted in a group format Topics will include FASARND education impact of FASARND on families specific development of a child with FASARND and FASARND social skills and deficits
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 12 and 18-month follow-ups Process eg parent satisfaction compliance etc and outcome eg behavior family functioning etc measures will be evaluated
Parent Component Three 90-minute sessions conducted in a group format Topics will include FASARND education impact of FASARND on families specific development of a child with FASARND and FASARND social skills and deficits
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 12 and 18-month follow-ups Process eg parent satisfaction compliance etc and outcome eg 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 |
|---|---|---|---|
| U84CCU020163-02 | None | None | None |