Back to resultsEvaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
Primary Purpose
Fetal Alcohol Spectrum Disorder, Attachment Disorders
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Circle of Security (COS)
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Spectrum Disorder focused on measuring Fetal Alcohol Spectrum Disorder, FASD
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.
Sites / Locations
- FASD Outreach Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Receives COS Intervention
Control Group-Regular FASD Services
Arm Description
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.
Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
Outcomes
Primary Outcome Measures
Attachment Classification
Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.
Secondary Outcome Measures
The Parenting Scale (TPS)
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)
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)
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
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.
Full Information
NCT ID
NCT01536184
First Posted
February 9, 2012
Last Updated
August 16, 2016
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT01536184
Brief Title
Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorder, Attachment Disorders
Keywords
Fetal Alcohol Spectrum Disorder, FASD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receives COS Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group-Regular FASD Services
Arm Type
No Intervention
Arm Description
Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
Intervention Type
Behavioral
Intervention Name(s)
Circle of Security (COS)
Other Intervention Name(s)
Attachment Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attachment Classification
Description
Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.
Time Frame
Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
Secondary Outcome Measure Information:
Title
The Parenting Scale (TPS)
Description
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.
Time Frame
Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
Title
The Parenting Stress Index (PSI)
Description
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
Time Frame
Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
Title
The Depression Anxiety Stress Scale (DASS)
Description
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.
Time Frame
Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
Title
The Strengths and Difficulties Questionnaire SDQ
Description
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.
Time Frame
Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Hanlon-Dearman, M.D.
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FASD Outreach
Organizational Affiliation
Family Services and Housing, Province of Manitoba
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Healthy Child Manitoba Office
Organizational Affiliation
Government of Manitoba
Official's Role
Study Chair
Facility Information:
Facility Name
FASD Outreach Program
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N0H6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
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