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

NCT01536184 | Completed Results

• 1 other identifier: H2012:015
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Alcohol Spectrum Disorder; Attachment Disorders

Keywords

Fetal Alcohol Spectrum Disorder; FASD

Outcome Measures

Primary Outcomes (1)

• Attachment Classification

  Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.

  Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

Secondary Outcomes (4)

• The Parenting Scale (TPS)

  Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

• The Parenting Stress Index (PSI)

  Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

• The Depression Anxiety Stress Scale (DASS)

  Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

• The Strengths and Difficulties Questionnaire SDQ

  Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

Study Arms (2)

Receives COS Intervention

EXPERIMENTAL

Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. 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. 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)

Control Group-Regular FASD Services

NO INTERVENTION

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.

Interventions

Circle of Security (COS) BEHAVIORAL

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.

Also known as: Attachment Intervention

Receives COS Intervention

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

FASD Outreach Program

Winnipeg, Manitoba, R3N0H6, Canada

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Limitations and Caveats

While we set out to conduct an RCT to evaluate the effectiveness of COS delivered in a home-visiting model vs. a behavioral TAU intervention, the limitations we faced did not allow for this.

Results Point of Contact

• Title: Dr. Ana Hanlon-Dearman
• Organization: Child Development Clinic SSCY Centre

ahdearman@hsc.mb.ca

204-258-6628

Study Officials

• Ana Hanlon-Dearman, M.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• FASD Outreach

  Family Services and Housing, Province of Manitoba

  STUDY CHAIR

• Healthy Child Manitoba Office

  Government of Manitoba

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Developmental Pediatrician

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 20, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 25, 2016
• Results First Posted: August 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)