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

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. CLINICALTRIAL: ClinicalTrials.gov NCT02210455; https://clinicaltrials.gov/ct2/show/NCT02210455 (Archived by WebCite at http://www.webcitation.org/6bbW5BSsT)