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

NCT ID: NCT01536184

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-12-31

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.

Detailed Description

See Arms and Intervention

Conditions

Fetal Alcohol Spectrum Disorder; Attachment Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Receives COS Intervention

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.

Group Type: EXPERIMENTAL

Circle of Security (COS)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Attachment Intervention

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ana Hanlon-Dearman

Developmental Pediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Hanlon-Dearman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

FASD Outreach

Role: STUDY_CHAIR

Family Services and Housing, Province of Manitoba

Healthy Child Manitoba Office

Role: STUDY_CHAIR

Government of Manitoba

Locations

FASD Outreach Program

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

H2012:015

Identifier Type: -

Identifier Source: org_study_id