Fetal Alcohol Spectrum Disorder Clinical Trial
Official title:
Strongest Families FASD: Parent Training for Challenging Behaviour in Children With Fetal Alcohol Spectrum Disorder (FASD)
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 Canada's (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, provincial/territorial 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 parent/guardian 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
parents/guardians and decision makers to develop and evaluate a training program for the
parents/guardians 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 parents/guardians of children with
FASD between the ages of 4-12 years, that is based on information collected from
interviews completed by major stakeholders (e.g., parents/guardians, 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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02912962 -
Self-Regulation in Adolescents With FASD: The Efficacy of a Targeted Intervention
|
N/A | |
| Completed |
NCT03802708 -
Fetal Alcohol Spectrum Disorder-Is This a Ciliopathy?
|
N/A | |
| Active, not recruiting |
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Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
|
N/A |