Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02210455
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2014-07-30
Brief Title:
Parenting Training for Children With FASD
Sponsor:
IWK Health Centre
Organization:
IWK Health Centre
Study Overview
Official Title:
Strongest Families FASD Parent Training for Challenging Behaviour in Children With Fetal Alcohol Spectrum Disorder FASD
Status:
COMPLETED
Status Verified Date:
2018-08
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:
SF-FASD
Brief Summary:
Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children and is the leading cause of mental disability in Canada The term fetal alcohol spectrum disorders FASD was established to encompass the full spectrum of teratogenic effects induced by alcohol FAS is believed to occur in approximately 1 to 3 per 1000 live births in North America and it is estimated that FASD may occur as frequently as 1 in 100 live births making this a public health problem of epidemic proportion Even though considerable efforts have been aimed at identifying children with FASD the need for access to services and supports for Canadian families affected by FASD remains unfulfilled Additionally there is little empirical data available to influence policy change in how these services and supports are delivered
A key recommendation contained in the Public Health Agency of Canadas PHAC Fetal Alcohol Spectrum Disorder FASD A Framework for Action document was the need to determine the types of supports children with FASD and their families require and to develop appropriate mechanisms to provide these services at the community provincialterritorial and federal levels This identified need forms the basis of the current proposal
Although a variety of psychosocial interventions have been developed to treat neurobehavioural disorders relatively little research has been conducted that is specifically aimed at improving the behavioral challenges identified in children with FASD Thus we hypothesize that i a FASD-specific parentguardian training intervention can be developed using input from major stakeholders to meet the current limitations in access for families seeking services and supports and ii this intervention and its evaluation will provide evidence for feasibility and efficacy to support changes in policy by key decision-makers and provide the basis for developing promising practices in the area of interventions for families affected by FASD This grant will link academic teams with parentsguardians and decision makers to develop and evaluate a training program for the parentsguardians of children with FASD
Participants will be recruited from across Canada The specific objectives of the proposed research program which will be addressed in three inter-related studies are to
1 Develop an Internet-based intervention program for parentsguardians of children with FASD between the ages of 4-12 years that is based on information collected from interviews completed by major stakeholders eg parentsguardians clinicians decision-makers community-based organizations
2 Evaluate the feasibility usability of the intervention and
3 Obtain data on outcomes from the randomized controlled trial This research will adopt an integrated knowledge translation and exchange approach where knowledge production dissemination uptake and usage will occur seamlessly throughout the project and researchers and knowledge users are engaged in the project right from its inception
The intervention will be based on the Strongest Families program that is designed to help families learn to deal with common childhood problems in the comfort and privacy of their home and provide treatment and care via telephone contact with trained coaches written manuals videotapes and audiotapes This program has been successful in children neurodevelopmental disorders and will be adapted for use in the FASD population as children with FASD share many of the same behavioral characteristics
A key recommendation contained in the Public Health Agency of Canadas PHAC Fetal Alcohol Spectrum Disorder FASD A Framework for Action document was the need to determine the types of supports children with FASD and their families require and to develop appropriate mechanisms to provide these services at the community provincialterritorial and federal levels This identified need forms the basis of the current proposal
Although a variety of psychosocial interventions have been developed to treat neurobehavioural disorders relatively little research has been conducted that is specifically aimed at improving the behavioral challenges identified in children with FASD Thus we hypothesize that i a FASD-specific parentguardian training intervention can be developed using input from major stakeholders to meet the current limitations in access for families seeking services and supports and ii this intervention and its evaluation will provide evidence for feasibility and efficacy to support changes in policy by key decision-makers and provide the basis for developing promising practices in the area of interventions for families affected by FASD This grant will link academic teams with parentsguardians and decision makers to develop and evaluate a training program for the parentsguardians of children with FASD
Participants will be recruited from across Canada The specific objectives of the proposed research program which will be addressed in three inter-related studies are to
1 Develop an Internet-based intervention program for parentsguardians of children with FASD between the ages of 4-12 years that is based on information collected from interviews completed by major stakeholders eg parentsguardians clinicians decision-makers community-based organizations
2 Evaluate the feasibility usability of the intervention and
3 Obtain data on outcomes from the randomized controlled trial This research will adopt an integrated knowledge translation and exchange approach where knowledge production dissemination uptake and usage will occur seamlessly throughout the project and researchers and knowledge users are engaged in the project right from its inception
The intervention will be based on the Strongest Families program that is designed to help families learn to deal with common childhood problems in the comfort and privacy of their home and provide treatment and care via telephone contact with trained coaches written manuals videotapes and audiotapes This program has been successful in children neurodevelopmental disorders and will be adapted for use in the FASD population as children with FASD share many of the same behavioral characteristics
Detailed Description:
None
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