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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
Results First Received: August 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Fetal Alcohol Spectrum Disorder
Attachment Disorders
Intervention: Behavioral: Circle of Security (COS)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The population studied were families with preschool children with FASD or PAE who were referred to the provincial FASD Outreach program or the FASD Family Support, Education and Counselling Program, a program of New Directions,between January 2011 – December 2013. The age range of children in the FASD Outreach Program is between 2 to 5 years old.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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

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.

Participant Flow:   Overall Study
    Receives COS Intervention     Control Group-Regular FASD Services  
STARTED     8     4  
COMPLETED     8     4  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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

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.
Total Total of all reporting groups

Baseline Measures
    Receives COS Intervention     Control Group-Regular FASD Services     Total  
Number of Participants  
[units: participants]
  8     4     12  
Age  
[units: years]
Mean (Full Range)
  4.1  
  (2 to 5)  
  NA  
  [1]
  4.1  
  (2 to 5)  
Age, Customized  
[units: Participants]
     
Less than or equal to 5 years old     8     4     12  
Greater than 5 years old     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     7     3     10  
Region of Enrollment  
[units: participants]
     
Canada     8     4     12  
[1] Specific age data not collected by the community therapists.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Attachment Classification   [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ]

2.  Secondary:   The Parenting Scale (TPS)   [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ]

3.  Secondary:   The Parenting Stress Index (PSI)   [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ]

4.  Secondary:   The Depression Anxiety Stress Scale (DASS)   [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ]

5.  Secondary:   The Strengths and Difficulties Questionnaire SDQ   [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ana Hanlon-Dearman
Organization: Child Development Clinic SSCY Centre
phone: 204-258-6628
e-mail: ahdearman@hsc.mb.ca



Responsible Party: Dr. Ana Hanlon-Dearman, 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