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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
Canadian Institutes of Health Research (CIHR)
Queen's University
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Patrick J. McGrath, IWK Health Centre

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 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.

Condition or disease Intervention/treatment
Fetal Alcohol Spectrum Disorder Behavioral: Strongest Families FASD intervention Other: Psychoeducation

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 Other: Psychoeducation
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.
Other: Psychoeducation

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a child between 4-12 years of age with a diagnosis which falls under the umbrella term "Fetal Alcohol Spectrum Disorder" as reported by parents/caregivers.
  • The child has been experiencing behavioural problems (as defined by the caregiver) for at least 6 months prior to study screening.
  • Have been the primary caregiver for a minimum of 6 months prior to entry into the study.
  • Have a reasonable expectation of being be the primary caregiver for at least 6 months after study enrolment.
  • Read, write, and understand English.
  • Have access to a telephone.
  • Have access to a computer connected to the Internet.
  • Live in Canada.
  • CBCL Externalizing t-Score must be ≥64 (clinical range)
  • The child meets criteria for behaviour suggestive of FASD
  • No suicide attempts within the previous 6 months
  • No current risk of suicide attempts

Exclusion Criteria:

  • Child is NOT able to speak in full sentences or understand everyday language and instructions.
  • Parent/caregiver has previously taken part in a Strongest Families Parenting Program.
  • Parent/caregiver OR child has been diagnosed with Psychosis.
  • Child does not have a diagnosis of schizophrenia, bipolar disorder or major depression.
  • Child does not put others as risk of serious harm (i.e., requiring medical attention).
  • Parent/caregiver has not completed any of the following parenting programs in the last 6 months: Triple P, COPE, Incredible Years.

Information from the National Library of Medicine

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)470.7552 karen.turner@iwk.nshealth.ca

Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Karen Turner, BA    1-877-341-8309 ext 4-2    fasdstdy@queensu.ca   
Sub-Investigator: James Reynolds, PhD         
Principal Investigator: Patrick McGrath, PhD         
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Queen's University
Public Health Agency of Canada (PHAC)
Principal Investigator: Patrick McGrath, PhD IWK Health Centre

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick J. McGrath, Integrated Vice President Research and Innovation, IWK Health Centre
ClinicalTrials.gov Identifier: NCT02210455     History of Changes
Other Study ID Numbers: 1017014
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016

Keywords provided by Patrick J. McGrath, IWK Health Centre:
Fetal Alcohol Syndrome
Partial Fetal Alcohol Syndrome
Alcohol Related Neurodevelopmental Disorder
Static Encephalopathy (Alcohol Exposed)
Neurobehavioural Disorder (Alcohol Exposed)

Additional relevant MeSH terms:
Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs