Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164307
Status:
COMPLETED
Last Update Posted:
2005-11-08
First Post:
2005-09-09
Brief Title:
Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships
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 be randomly assigned to a Parent-assisted social skills training or Wait list Baseline and post intervention rating will be obtained from teachers
Detailed Description:
Targeted Area of Intervention Social skills and development of best friend relationships The specific intervention will be twelve small group sessions 90 minutes each over a 6-week period Child sessions consist of 4 components 1 children report on homework assignments 2 didactic presentation behavioral rehearsal and coaching 3 coached play and 4 new homework activities assigned with parent Topics to be addressed across sessions include reduction of maladaptive behaviors information exchange techniques places and times to make friends group acceptance praising other children negotiation play dates dealing with teasing and winnerloser skills At the start of the intervention parent and children will work with staff to develop a list of social skills behaviors and goals that they would like targeted for each child
Parent component Kathleen Mitchell NOFAS is an investigator to provide parent input to the study Parent-only sessions will instruct them on key features being taught to their child Concurrent parent sessions will include 1 education on FASARND 2 parents present specific issues with their child 3 review of current child session objectives and techniques 4 new homework activities developed 5 parent and child together review homework
Evaluation Plan Treatment and control WL groups will be compared using pre- and post-tests measures Post-tests will be at the conclusion of the intervention and at a 4-month follow-up Baseline parent measures include Social Skills Rating Scale FAS Behavior Scale and Test of Advocacy Knowledge Baseline child measures include knowledge of social skills Process eg homework completion attendance etc and outcome eg social skills ratings progress towards individual goals measures will be evaluated
Parent component Kathleen Mitchell NOFAS is an investigator to provide parent input to the study Parent-only sessions will instruct them on key features being taught to their child Concurrent parent sessions will include 1 education on FASARND 2 parents present specific issues with their child 3 review of current child session objectives and techniques 4 new homework activities developed 5 parent and child together review homework
Evaluation Plan Treatment and control WL groups will be compared using pre- and post-tests measures Post-tests will be at the conclusion of the intervention and at a 4-month follow-up Baseline parent measures include Social Skills Rating Scale FAS Behavior Scale and Test of Advocacy Knowledge Baseline child measures include knowledge of social skills Process eg homework completion attendance etc and outcome eg social skills ratings progress towards individual goals 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 |
|---|---|---|---|
| U84CCU9201158-01 | None | None | None |