Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
This study is not yet open for participant recruitment.
Verified February 2012 by University of Manitoba
Sponsor:
University of Manitoba
Information provided by (Responsible Party):
Dr. Ana Hanlon-Dearman, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01536184
First received: February 9, 2012
Last updated: February 15, 2012
Last verified: February 2012
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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:
- 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: | 60 |
| 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 |
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 |
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 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: | February 15, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Manitoba:
|
Fetal Alcohol Spectrum Disorder FASD |
ClinicalTrials.gov processed this record on May 16, 2013