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Trial record 3 of 35 for:    fetal alcohol children

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

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ClinicalTrials.gov Identifier: NCT01536184
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ana Hanlon-Dearman, University of Manitoba

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Fetal Alcohol Spectrum Disorder
Attachment Disorders
Intervention Behavioral: Circle of Security (COS)
Enrollment 12
Recruitment Details 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  
Arm/Group Title Receives COS Intervention Control Group-Regular FASD Services
Hide Arm/Group 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.

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

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
Period Title: Overall Study
Started 8 4
Completed 8 4
Not Completed 0 0
Arm/Group Title Receives COS Intervention Control Group-Regular FASD Services Total
Hide Arm/Group 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.

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

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports. Total of all reporting groups
Overall Number of Baseline Participants 8 4 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 4 participants 12 participants
4.1
(2 to 5)
NA [1] 
(NA to NA)
4.1
(2 to 5)
[1]
Specific age data not collected by the community therapists.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Less than or equal to 5 years old 8 4 12
Greater than 5 years old 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Female
1
  12.5%
1
  25.0%
2
  16.7%
Male
7
  87.5%
3
  75.0%
10
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 8 participants 4 participants 12 participants
8 4 12
1.Primary Outcome
Title Attachment Classification
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed Receives COS Intervention Pretest= 8; Post-test=3; Follow-up=4 Control Group Pretest=4; Post-test=1; Follow-up=1
Arm/Group Title Receives COS Intervention Control Group-Regular FASD Services
Hide Arm/Group 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.

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

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
Overall Number of Participants Analyzed 8 4
Measure Type: Number
Unit of Measure: participants
Secure (pretest) 0 0
Anxious-Insecure (pretest) 0 0
Anxious-Avoidant (pretest) 0 0
Avoidant (pretest) 3 0
Disordered (pretest) 5 4
Secure (post test) 1 0
Anxious-Insecure (post test) 0 0
Anxious-Avoidant (post test) 0 0
Avoidant (post test) 0 0
Disordered (post test) 2 1
Secure (followup) 1 0
Anxioius-Insecure (followup) 0 0
Anxious-Avoidant (followup) 0 0
Avoidant (followup) 0 0
Disordered (followup) 3 1
2.Secondary Outcome
Title The Parenting Scale (TPS)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2
Arm/Group Title Receives COS Intervention Control Group-Regular FASD Services
Hide Arm/Group 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.

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

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
Overall Number of Participants Analyzed 8 4
Mean (Full Range)
Unit of Measure: units on a scale
TPS Total (pretest)
4.08
(2.57 to 4.43)
2.3
(1.71 to 3.13)
TPS Total (post test)
2.97
(2.4 to 4.07)
3.27
(3.17 to 3.37)
TPS Total (followup)
2.67
(1.87 to 3.33)
2.6
(2.03 to 3.17)
TPS Laxness (pretest)
3.22
(1.82 to 5.55)
2.22
(1.56 to 4.55)
TPS Laxness (post test)
2.97
(1.81 to 5.0)
3.14
(3.11 to 3.18)
TPS Laxness (followup)
2.47
(2.0 to 3.36)
2.46
(1.91 to 3.0)
TPS Overreactivity (pretest)
2.39
(1.9 to 3.2)
1.65
(1.2 to 2.2)
TPS Overreactivity (post test)
2.18
(1.8 to 2.6)
2.53
(2.25 to 2.8)
TPS Overreactivity (follow up)
2.46
(1.5 to 3.5)
1.85
(1.7 to 2.0)
TPS Verbosity (pretest)
3.54
(1.86 to 4.43)
2.80
(2.0 to 4.0)
TPS Verbosity (post test)
3.56
(3.0 to 4.86)
3.52
(3.17 to 3.86)
TPS Verbosity (follow up)
3.11
(2.14 to 4.29)
3.36
(2.71 to 4.0)
3.Secondary Outcome
Title The Parenting Stress Index (PSI)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Receives COS Intervention Control Group-Regular FASD Services
Hide Arm/Group 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.

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

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
Overall Number of Participants Analyzed 8 4
Mean (Full Range)
Unit of Measure: units on a scale
DR (pretest) n=8, n=4
25.13
(11 to 34)
14.25
(10 to 19)
DR (post test) n=6, 1
15.66
(12 to 22)
16
(16 to 16)
DR (followup) n=5, n=2
19
(9 to 30)
18
(17 to 19)
PD (pretest) n=8, n=4
42.75
(17 to 57)
24
(17 to 31)
PD (post test) n=6, n=1
27
(20 to 38)
29
(29 to 29)
PD (followup) n=5, n=2
33.4
(14 to 52)
30.5
(30 to 31)
PCDI (pretest) n=8, n=4
37.5
(22 to 50)
24.5
(16 to 33)
PCDI (post test) n=6, n=1
25.66
(21 to 31)
31
(31 to 31)
PCDI (followup) n=5, n=2
27.8
(14 to 43)
24
(19 to 29)
DC (pretest) n=8, n=4
35.75
(28 to 46)
40.75
(28 to 53)
DC (post test) n=6, n=1
33.66
(20 to 44)
56
(56 to 56)
DC (followup) n=5, n=2
35.4
(25 to 42)
42
(34 to 50)
PSI total Stress (pretest) n=8, n=4
116
(89 to 144)
89.25
(74 to 111)
PSI total Stress (post test) n=6, n=1
86.33
(74 to 103)
116
(116 to 116)
PSI total Stress (followup) n=5, n=2
96.6
(53 to 128)
96.5
(83 to 110)
4.Secondary Outcome
Title The Depression Anxiety Stress Scale (DASS)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2
Arm/Group Title Receives COS Intervention Control Group-Regular FASD Services
Hide Arm/Group 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.

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

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
Overall Number of Participants Analyzed 8 4
Mean (Full Range)
Unit of Measure: units on a scale
DASS-D (pretest)
2.63
(0 to 13)
1
(0 to 2)
DASS-D (post test)
3.33
(1 to 7)
0
(0 to 0)
DASS-D (followup)
5.2
(0 to 17)
0
(0 to 0)
DASS-A (pretest)
4.13
(0 to 11)
0.5
(0 to 2)
DASS-A (post test)
4.5
(0 to 9)
0
(0 to 0)
DASS-A (followup)
4
(0 to 16)
0
(0 to 0)
DASS-S (pretest)
7.63
(2 to 19)
3
(0 to 5)
DASS-S (post test)
6.17
(1 to 11)
4.5
(0 to 9)
DASS-S (followup)
9
(2 to 18)
2
(0 to 4)
5.Secondary Outcome
Title The Strengths and Difficulties Questionnaire SDQ
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Please see category specific n values below.
Arm/Group Title Receives COS Intervention Control Group-Regular FASD Services
Hide Arm/Group 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.

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

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
Overall Number of Participants Analyzed 8 4
Mean (Full Range)
Unit of Measure: units on a scale
SDQ-ES (pretest) n=7, n=4
2.86
(2 to 4)
4.5
(2 to 7)
SDQ-ES (post test) n=6, n=1
4.33
(2 to 8)
3
(3 to 3)
SDQ-ES (followup) n=5, n=2
3.8
(1 to 4)
3
(1 to 3)
SDQ-CP (pretest) n=5, n=4
5
(1 to 6)
4.5
(1 to 8)
SDQ-CP (post test) n=6, n=1
3.66
(0 to 7)
7
(7 to 7)
SDQ-CP (followup) n=5, n=2
4.8
(3 to 7)
4
(1 to 7)
SDQ-HA (pretest)n=6, n=4
8.17
(5 to 10)
8
(6 to 10)
SDQ-HA (post test) n=6, n=1
6.66
(4 to 10)
9
(9 to 9)
SDQ-HA (followup) n=5, n=2
7.8
(5 to 10)
6.5
(5 to 8)
SDQ- PP (pretest) n=7, n=4
3
(0 to 7)
4
(3 to 5)
SDQ- PP (post test)n=6, n=1
3.33
(1 to 5)
6
(6 to 6)
SDQ- PP (followup)n= 5, n=2
2.8
(1 to 4)
3
(2 to 4)
SDQ-PS (pretest) n=7, n=4
5.86
(4 to 7)
6
(4 to 8)
SDQ-PS (post test) n=6, n=1
6.66
(4 to 9)
5
(5 to 5)
SDQ-PS (followup) n=5, n=2
6.2
(6 to 8)
7
(5 to 9)
Total SDQ (pretest)n=7, n=4
18.71
(14 to 27)
21
(15 to 25)
Total SDQ (post test)n=6, n=1
18
(14 to 28)
25
(25 to 25)
Total SDQ (followup) n=5, n=2
19.2
(9 to 22)
16
(10 to 22)
Total IS (pretest) n=7, n=4
4.43
(1 to 8)
5.5
(2 to 10)
Total IS (post test) n=6, n=1
2.12
(0 to 5)
10
(10 to 10)
Total IS (followup)n=5, n=0
3.4
(2 to 7)
NA [1] 
(NA to NA)
[1]
No data could be collected for this test as participant did not attend assessment
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not assessed.
 
Arm/Group Title Receives COS Intervention Control Group-Regular FASD Services
Hide Arm/Group 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.

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

Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
All-Cause Mortality
Receives COS Intervention Control Group-Regular FASD Services
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Receives COS Intervention Control Group-Regular FASD Services
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Receives COS Intervention Control Group-Regular FASD Services
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
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
Responsible Party: Dr. Ana Hanlon-Dearman, University of Manitoba
ClinicalTrials.gov Identifier: NCT01536184     History of Changes
Other Study ID Numbers: H2012:015
First Submitted: February 9, 2012
First Posted: February 20, 2012
Results First Submitted: August 16, 2016
Results First Posted: August 25, 2016
Last Update Posted: August 25, 2016