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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01536184
• Other study ID #: H2012:015
• Status: Active, not recruiting
• Phase: N/A
• First received: February 9, 2012
• Last updated: January 26, 2015
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

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.

Description:

See Arms and Intervention

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• Two criteria must be present for a family (caregiver-child dyad) to be included in the COS component of the FASD Outreach Program and its evaluation:

• the child was exposed to alcohol prenatally and has been clinically evaluated using the Canadian FASD diagnostic guidelines as having Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), Alcohol Related Neurodevelopmental Disorder (ARND), or is considered "at risk" for FASD based on their confirmed history of prenatal alcohol exposure and clinical multidisciplinary assessment; and

• evidence of disrupted caregiver behaviours or problems in the caregiver-child interaction as identified through a screening process consisting of clinical judgment and the SBSH procedure.

Exclusion Criteria:

• children from foster families who have experienced more than 2 placements in the last six months,

• children who have an Autism diagnosis,

• children with a developmental quotient less than 50,

• children with sensory impairments (hearing or sight impaired), and

• children who are already involved in New Directions' 'Self Regulation Therapy Project'.

Children who have parents who are clinically depressed, whose parents have substance abuse or domestic violence issues, or whose parents display a narcissistic devaluation personality trait based on initial clinical evaluation, will also be excluded from study eligibility.

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

Intervention

Behavioral:
• Circle 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.

Locations

Country	Name	City	State
Canada	FASD Outreach Program	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attachment Classification	Attachment classified using Ainsworth's Strange Situation protocol: Secure, Avoidant, Resistant, Disorganized, Insecure	36 sessions (approx. 9 months)	No
Secondary	Change in the Parenting Scale	A self-report measure of dysfunctional parenting practices including laxness, over-reactivity, and verbosity that will used to measure changes in parenting behaviours.	Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)	No
Secondary	Change in the Parenting Stress Index	A parent-report questionnaire of parental stress, parent-child interaction style, and difficult child behaviour that will be used to measure changes in parental stress.	Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)	No
Secondary	Change in the Depression Anxiety Stress Scale	A self-report measure of depression, anxiety, and stress that will be used to measure changes in parental depression and anxiety traits.	Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)	No
Secondary	Change in the Strengths and Difficulties Questionnaire	A parent-report measure that will be used to measure changes in the psychological adjustment of children.	Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)	No