Clinical Trial: Parenting Training for Children With FASD

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Strongest Families FASD: Parent Training for Challenging Behaviour in Children With Fetal Alcohol Spectrum Disorder (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 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 ch

Detailed Summary:
Sponsor: IWK Health Centre

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: IWK Health Centre

Dates:
Date Received: July 30, 2014
Date Started: July 2014
Date Completion: April 2017
Last Updated: March 8, 2016
Last Verified: March 2016