title: Guided Internet-Based Parent Training for Challenging Behavior in Children With Fetal Alcohol Spectrum Disorder (Strongest Families FASD): Study Protocol for a Randomized Controlled Trial.
abstract: BACKGROUND
  Fetal alcohol spectrum disorder (FASD) is a term used to encompass the full range of neurobehavioral and cognitive dysfunction that may occur as a consequence of prenatal alcohol exposure. There is relatively little research on intervention strategies that specifically target the behavioral problems of children with FASD. Availability and access to services are barriers to timely and effective care for families. The Strongest Families FASD intervention was recently adapted from the Strongest Families "Parenting the Active Child" program to include FASD-specific content delivered via an Internet-based application in conjunction with 11 telephone coaching sessions.
  
  
  OBJECTIVE
  Our objectives are to (1) evaluate the effectiveness of Strongest Families FASD in reducing externalizing problems (primary outcome), internalizing problems, and parent distress (secondary outcomes) in children aged between 4 and 12 years diagnosed with FASD when compared to a control group with access to a static resource Web page; (2) evaluate the effectiveness of Strongest Families FASD in improving social competence (secondary outcome) in school-aged children aged between 6 and 12 diagnosed with FASD when compared with an online psychoeducation control; and (3) explore parental satisfaction with the Strongest Families FASD online parenting program.
  
  
  METHODS
  Parents and caregivers (N=200) of children diagnosed with FASD who have significant behavioral challenges, ages 4-12, are being recruited into a 2-arm randomized trial. The trial is designed to evaluate the effectiveness of the Web-based Strongest Families FASD parenting intervention on child behavior and caregiver distress, compared to a control group receiving access to a static resource Web page (ie, a list of FASD-specific websites, readings, videos, and organizations).
  
  
  RESULTS
  The primary outcome will be externalizing problems measured by the Child Behavior Checklist (CBCL). Secondary outcomes include (1) internalizing problems and (2) social competence, both measured by the CBCL; and (3) parental distress measured by the Depression Anxiety Stress Scale-21. The Client Satisfaction Questionnaire-8 (CSQ-8) and the Satisfaction Survey are completed by the intervention group at the end of session 11. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials (CONSORT) Statement.
  
  
  CONCLUSIONS
  It is hypothesized that the Strongest Families FASD intervention group will improve child behavior and parental distress. Caregiver satisfaction is anticipated to be positive. Advancing evidence on the effectiveness and acceptance of distance services can inform policy and adoption of eHealth programs.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02210455; https://clinicaltrials.gov/ct2/show/NCT02210455 (Archived by WebCite at http://www.webcitation.org/6bbW5BSsT).
authors.affiliation: IWK Health Centre, Halifax, NS, Canada. karen.turner@iwk.nshealth.ca.
authors.forename: Karen
authors.identifier: http://orcid.org/0000-0002-9983-0893
authors.initials: K
authors.lastname: Turner
authors.forename: James N
authors.identifier: http://orcid.org/0000-0001-8837-2295
authors.initials: JN
authors.lastname: Reynolds
authors.forename: Patrick
authors.identifier: http://orcid.org/0000-0002-9568-2571
authors.initials: P
authors.lastname: McGrath
authors.forename: Patricia
authors.identifier: http://orcid.org/0000-0001-6408-0132
authors.initials: P
authors.lastname: Lingley-Pottie
authors.forename: Anna
authors.identifier: http://orcid.org/0000-0002-4002-8644
authors.initials: A
authors.lastname: Huguet
authors.forename: Amy
authors.identifier: http://orcid.org/0000-0002-9866-8628
authors.initials: A
authors.lastname: Hewitt
authors.forename: Courtney
authors.identifier: http://orcid.org/0000-0003-4367-4163
authors.initials: C
authors.lastname: Green
authors.forename: Lori
authors.identifier: http://orcid.org/0000-0001-6933-9596
authors.initials: L
authors.lastname: Wozney
authors.forename: Christopher
authors.identifier: http://orcid.org/0000-0001-9583-4865
authors.initials: C
authors.lastname: Mushquash
authors.forename: Nazeem
authors.identifier: http://orcid.org/0000-0001-6781-5421
authors.initials: N
authors.lastname: Muhajarine
authors.forename: Andre
authors.identifier: http://orcid.org/0000-0003-0361-7244
authors.initials: A
authors.lastname: Sourander
authors.forename: Heather
authors.identifier: http://orcid.org/0000-0002-0407-1856
authors.initials: H
authors.lastname: Caughey
authors.forename: Jessica
authors.identifier: http://orcid.org/0000-0002-1249-6934
authors.initials: J
authors.lastname: Roane
keywords: Strongest Families; Web-based intervention; children; disruptive behavior; eHealth; fetal alcohol spectrum disorder; neurobehavioral disorder; parenting; prenatal alcohol exposure; randomized controlled trial