Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD

Fetal Alcohol Spectrum Disorder Clinical Trial

Official title: Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With Fetal Alcohol Spectrum Disorder (FASD) or At-risk for FASD: A Randomized Controlled Field Trial

Status Active, not recruiting

Clinical Trial Summary

Study Summary: This study is being conducted in order to rigorously evaluate the real-world effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of Security (COS) Family Intervention Model (Marvin) in improving caregiving and child outcomes in families who have children with Fetal Alcohol Spectrum Disorder (FASD) or who are at-risk for FASD, as delivered under routine practice conditions.

Hypothesis: At post-test (after 36 sessions and 3-month follow-up), compared to a wait-list control group receiving standard services, the treatment group receiving COS will show greater improvement in caregiver behaviour, as well as child emotional and behavioural outcomes.

Clinical Trial Description

See Arms and Intervention ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attachment Disorders
• Disease
• Fetal Alcohol Spectrum Disorder
• Fetal Alcohol Spectrum Disorders

• NCT number: NCT01536184
• Study type: Interventional
• Source: University of Manitoba
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2012
• Completion date: December 2015