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

This study has been completed.
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 16, 2016
Last verified: August 2016
  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) 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.


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: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ] [ Designated as safety issue: No ]
    Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.


Secondary Outcome Measures:
  • The Parenting Scale (TPS) [ 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. The scale has good internal consistency and test-restest reliability and scores are consistent with other measures of dysfunctional discipline and child misbehaviour.

    Each subscale score, ranges from 1 to 7; for each subscale (Laxness, Overreactivity, Verbosity) lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours. The total score is calculated from a combination of each subscale and also ranges from 1 to 7, reflecting the degree of ineffective parenting behaviours across all categories with lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours.


  • The Parenting Stress Index (PSI) [ 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 reflecting parent-child interaction style and difficult child behaviour. There are two main domain scores, a Child Domain Score and Parent Domain Score from which a Total Stress Score is calculated.

    Child and Parent Domain raw scores combine to form a Total Stress raw score. Higher scores for each item indicate a higher degree of negative attributes in the given scale while lower scores indicate lower relationship stress and a greater sense of enjoyment in the relationship.

    Items include:

    Defensive Responding (DR) Score range 7-35 Parental Distress (PD) Score range 12-60 Parent-Child Dysfunctional Interaction (PCDI) Score range 12-60 Difficult Child (DC) Score range 12-60 PSI Total Stress Score range 36-180


  • The Depression Anxiety Stress Scale (DASS) [ 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. The scales of the DASS show high internal consistency and produce meaningful discriminations in different settings, and are appropriate for measuring the emotional states of caregivers over time.

    The score for each item ranges from 0 to 3, where 0 indicates "did not apply to me at all" and 3 indicates "applied to me very much, or most of the time". The individual items are combined using a scoring template into measures of Depression (D), Anxiety (A), and Stress (S). Depression is scored out of 28 where 0-9 is normal and 10-28 reflect mild, moderate, and severe degrees of depression. Anxiety is scored out of 20 where 0-7 is normal and 8-20 reflect mild, moderate, and severe degrees of anxiety. Stress is scored out of 34 where 0-14 is normal and 15-34 reflect mild, moderate, and severe degrees of stress.


  • The Strengths and Difficulties Questionnaire SDQ [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ] [ Designated as safety issue: No ]
    The Emotional Symptoms (SDQ-ES), Conduct Problems (SDQ-CP), Hyperactivity (SDQ-HA), Peer Problems (SDQ-PP), and Prosocial (SDQ-PS) Scales each range from 0-10 Higher values in (ES, CP, HA, and PP) indicate a greater degree of abnormal behavior; low values indicate more normative behavior. For the PS scale, higher values indicate greater strengths in prosocial behaviour and lower values indicate more difficulties with prosocial behavior. A Total Difficulties Score ranges from 0 to 40 with higher scores reflecting higher levels of behavioral difficulty. The Total Impact Supplement Score (Total IS) ranges from 0 to 10 with higher values indicating greater behavioral difficulty and social impairment.


Enrollment: 12
Study Start Date: March 2012
Study Completion Date: December 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

Detailed Description:
See Arms and Intervention
  Eligibility

Ages Eligible for Study:   2 Years to 5 Years   (Child)
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
Winnipeg, Manitoba, Canada, R3N0H6
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

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
Results First Received: August 16, 2016
Last Updated: August 16, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: No

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 September 30, 2016