Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164346
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2005-09-09
Brief Title:
Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome FASAlcohol-Related Neurodevelopmental Disorder ARND
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Neurocognitive Habilitation for Children With FASARND
Status:
COMPLETED
Status Verified Date:
2011-03
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 Childrens Research Triangle CRT clinical program The assessment for the child will be in accordance with the protocol developed by Astley and Clarren as performed by one of the clinic pediatricians and final diagnosis will be according to Institute of Medicine IOM criteria Children will be randomized into either a Treatment or Control group The Treatment group will receive in addition to standard referrals neurocognitive habilitation and psychotherapy services as well as parent psychoeducation The Control group will be referred for intervention through existing community and school-based agencies
Detailed Description:
Neurocognitive habilitation based on the traumatic brain injury literature for teaching compensatory skills will be the primary intervention Interventions will be individually designed and delivered through individual therapy sessions Audiotapes will augment the sessions to facilitate implementation of strategies in the home environment Didactic therapy will be used to foster appropriate interactions and relationships between parent and child Children will participate in 8-week group sessions that will include neurocognitive exercises homework sessions and possibly group psychotherapy An educational specialist will provide school and legal advocacy services as well as observations of the child in the classroom that could lead to educational modifications
Parent Component Family education programs and parent support groups using psychoeducational approaches will be the means of intervening with parent behaviors Parents will be instructed on becoming advocates for their child Groups of 8 to 12 parents will meet for one 2-hour session per week for 8 weeks Each session will include
1 neurocognitive exercises relaxation
2 specific topic discussions and
3 general support
During the last hour of the final two weeks of the program parent and children will be combined to practice learned techniques Children and parents will participate in monthly booster sessions
Evaluation Plan Treatment and control groups will be compared using pre- and post-test measures Post-tests will be at the conclusion of the intervention as well as at 12 and 24-month follow-ups Process and outcome measures will be evaluated
Parent Component Family education programs and parent support groups using psychoeducational approaches will be the means of intervening with parent behaviors Parents will be instructed on becoming advocates for their child Groups of 8 to 12 parents will meet for one 2-hour session per week for 8 weeks Each session will include
1 neurocognitive exercises relaxation
2 specific topic discussions and
3 general support
During the last hour of the final two weeks of the program parent and children will be combined to practice learned techniques Children and parents will participate in monthly booster sessions
Evaluation Plan Treatment and control groups will be compared using pre- and post-test measures Post-tests will be at the conclusion of the intervention as well as at 12 and 24-month follow-ups Process and outcome 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 |
|---|---|---|---|
| U84CCU520164-01 | None | None | None |