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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr. Ana Hanlon-Dearman, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01536184
First received: February 9, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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) 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.


Condition Intervention
Fetal Alcohol Spectrum Disorder
Attachment Disorders
Behavioral: Circle of Security (COS)

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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Attachment Classification [ Time Frame: 36 sessions (approx. 9 months) ] [ Designated as safety issue: No ]
    Attachment classified using Ainsworth's Strange Situation protocol: Secure, Avoidant, Resistant, Disorganized, Insecure


Secondary Outcome Measures:
  • Change in the Parenting Scale [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ] [ Designated as safety issue: No ]
    A self-report measure of dysfunctional parenting practices including laxness, over-reactivity, and verbosity that will used to measure changes in parenting behaviours.

  • Change in the Parenting Stress Index [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ] [ Designated as safety issue: No ]
    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.

  • Change in the Depression Anxiety Stress Scale [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ] [ Designated as safety issue: No ]
    A self-report measure of depression, anxiety, and stress that will be used to measure changes in parental depression and anxiety traits.

  • Change in the Strengths and Difficulties Questionnaire [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ] [ Designated as safety issue: No ]
    A parent-report measure that will be used to measure changes in the psychological adjustment of children.


Estimated Enrollment: 15
Study Start Date: March 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Receives COS Intervention
Circle of Security (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 Bowlby and Ainsworth and integrates principles of emotional regulation and attachment. The goals of the intervention as described by Hoffman 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. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
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.
Other Name: Attachment Intervention
No Intervention: Control Group-Regular FASD Services
Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536184

Locations
Canada, Manitoba
FASD Outreach Program Recruiting
Winnipeg, Manitoba, Canada, R3N0H6
Contact: Ana Hanlon-Dearman, MD    204-787-2463      
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Ana Hanlon-Dearman, M.D. University of Manitoba
Study Chair: FASD Outreach Family Services and Housing, Province of Manitoba
Study Chair: Healthy Child Manitoba Office Government of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Ana Hanlon-Dearman, Developmental Pediatrician, University of Manitoba
ClinicalTrials.gov Identifier: NCT01536184     History of Changes
Other Study ID Numbers: H2012:015
Study First Received: February 9, 2012
Last Updated: August 26, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Fetal Alcohol Spectrum Disorder
FASD

Additional relevant MeSH terms:
Disease
Fetal Alcohol Spectrum Disorders
Pathologic Processes
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 01, 2014