An interventional study of Circle of Security (COS) in Fetal Alcohol Spectrum Disorder and Attachment Disorders, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2016-08-25.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
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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:
Exclusion Criteria:
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.
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)
Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
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.
Also known as: Attachment Intervention
Attachment Classification
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)
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.
Time frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
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
Time frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
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.
Time frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
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.
Time frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
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.
| Milestone | Receives COS Intervention | Control Group-Regular FASD Services |
|---|---|---|
| Started | 8 | 4 |
| Completed | 8 | 4 |
| Not completed | 0 | 0 |
Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.
| participants | Receives COS Intervention | Control Group-Regular FASD Services |
|---|---|---|
| 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 |
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.
| units on a scale | Receives COS Intervention | Control Group-Regular FASD Services |
|---|---|---|
| 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) |
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
| units on a scale | Receives COS Intervention | Control Group-Regular FASD Services |
|---|---|---|
| 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) |
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.
| units on a scale | Receives COS Intervention | Control Group-Regular FASD Services |
|---|---|---|
| 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) |
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.
| units on a scale | Receives COS Intervention | Control Group-Regular FASD Services |
|---|---|---|
| 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 (NA to NA) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Receives COS Intervention | — | — | — |
| Control Group-Regular FASD Services | — | — | — |
| Age, Continuous(years) | Receives COS Intervention | Control Group-Regular FASD Services | Total |
|---|---|---|---|
| Mean | 4.1 (2 to 5) | NA (NA to NA) | 4.1 (2 to 5) |
| Age, Customized(Participants) | Receives COS Intervention | Control Group-Regular FASD Services | Total |
|---|---|---|---|
| Less than or equal to 5 years old | 8 | 4 | 12 |
| Greater than 5 years old | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Receives COS Intervention | Control Group-Regular FASD Services | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 7 | 3 | 10 |
| Region of Enrollment(participants) | Receives COS Intervention | Control Group-Regular FASD Services | Total |
|---|---|---|---|
| Canada | 8 | 4 | 12 |
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University of Manitoba