Parenting Training for Children With FASD (SF-FASD)
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|ClinicalTrials.gov Identifier: NCT02210455|
Recruitment Status : Unknown
Verified March 2016 by Patrick J. McGrath, IWK Health Centre.
Recruitment status was: Recruiting
First Posted : August 6, 2014
Last Update Posted : March 9, 2016
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:
- 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);
- Evaluate the feasibility (usability) of the intervention; and
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Fetal Alcohol Spectrum Disorder||Behavioral: Strongest Families FASD intervention Other: Psychoeducation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Strongest Families FASD: Parent Training for Challenging Behaviour in Children With Fetal Alcohol Spectrum Disorder (FASD)|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: The Strongest Families FASD intervention
It is a web-based parent training program with a coach. The program is comprised of 11 sessions, each focusing on a different parenting strategy, delivered using easy to read text, instructional videos and audio clips. One Booster Session is conducted 1 month after completion of Session 11.
Behavioral: Strongest Families FASD intervention
Active Comparator: Psychoeducation
It is a static webpage on IRIS providing FASD information and resources, including recommended book titles, websites and organizations that may be helpful.
- A change on the Child Behavior Checklist from baseline to 11 months [ Time Frame: At baseline, and 5 months and 11 months after randomization ]It is a standardized questionnaire that assesses adaptive functioning and problems. We will use two versions of the CBCL (CBCL/1 ½ -5 and CBCL/6-18) to accommodate the age range of the sample
- A change on the Depression Anxiety & Stress Scale Short Form (DASS-21) from baseline to 11 months [ Time Frame: At baseline, and 5 months and 11 months after randomization ]It will be used to evaluate parental distress
- Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Participants will be asked to complete this measure at the end of the intervention, which will probably last on average 5 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210455
|Contact: Karen Turner, BA||(902)firstname.lastname@example.org|
|Canada, Nova Scotia|
|IWK Health Centre||Recruiting|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Contact: Karen Turner, BA 1-877-341-8309 ext 4-2 email@example.com|
|Sub-Investigator: James Reynolds, PhD|
|Principal Investigator: Patrick McGrath, PhD|
|Principal Investigator:||Patrick McGrath, PhD||IWK Health Centre|