Clinical Trials Directory

Trials / Completed

CompletedNCT01536184

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

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
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University of Manitoba · Academic / Other
Sex
All
Age
2 Years – 5 Years
Healthy volunteers
Not accepted

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.

Detailed description

See Arms and Intervention

Conditions

Interventions

TypeNameDescription
BEHAVIORALCircle of Security (COS)COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment theory of John Bowlby and Mary Ainsworth and integrates neuroscientific principles of emotional regulation and attachment. The protocol contains both educational and therapeutic components. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour.

Timeline

Start date
2012-03-01
Primary completion
2015-01-01
Completion
2015-12-01
First posted
2012-02-20
Last updated
2016-08-25
Results posted
2016-08-25

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01536184. Inclusion in this directory is not an endorsement.

Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD (NCT01536184) · Clinical Trials Directory