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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01536184
Enrollment
12
Registered
2012-02-20
Start date
2012-03-31
Completion date
2015-12-31
Last updated
2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attachment Disorders, Fetal Alcohol Spectrum Disorder

Keywords

Fetal Alcohol Spectrum Disorder, FASD

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

Interventions

BEHAVIORALCircle 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.

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Attachment ClassificationAdministered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.

Secondary

MeasureTime frameDescription
The Parenting Scale (TPS)Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)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)Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)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)Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)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 SDQAdministered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)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.

Countries

Canada

Participant flow

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.

Participants by arm

ArmCount
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
8
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.
4
Total12

Baseline characteristics

CharacteristicTotalReceives COS InterventionControl Group-Regular FASD Services
Age, Continuous4.1 years4.1 yearsNA years
Age, Customized
Greater than 5 years old
0 Participants0 Participants0 Participants
Age, Customized
Less than or equal to 5 years old
12 Participants8 Participants4 Participants
Region of Enrollment
Canada
12 participants8 participants4 participants
Sex: Female, Male
Female
2 Participants1 Participants1 Participants
Sex: Female, Male
Male
10 Participants7 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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)

Population: 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

ArmMeasureGroupValue (NUMBER)
Receives COS InterventionAttachment ClassificationDisordered (post test)2 participants
Receives COS InterventionAttachment ClassificationAvoidant (followup)0 participants
Receives COS InterventionAttachment ClassificationAnxious-Insecure (post test)0 participants
Receives COS InterventionAttachment ClassificationDisordered (followup)3 participants
Receives COS InterventionAttachment ClassificationSecure (followup)1 participants
Receives COS InterventionAttachment ClassificationSecure (pretest)0 participants
Receives COS InterventionAttachment ClassificationAvoidant (post test)0 participants
Receives COS InterventionAttachment ClassificationAnxious-Insecure (pretest)0 participants
Receives COS InterventionAttachment ClassificationAnxioius-Insecure (followup)0 participants
Receives COS InterventionAttachment ClassificationAnxious-Avoidant (pretest)0 participants
Receives COS InterventionAttachment ClassificationAnxious-Avoidant (post test)0 participants
Receives COS InterventionAttachment ClassificationAvoidant (pretest)3 participants
Receives COS InterventionAttachment ClassificationAnxious-Avoidant (followup)0 participants
Receives COS InterventionAttachment ClassificationDisordered (pretest)5 participants
Receives COS InterventionAttachment ClassificationSecure (post test)1 participants
Control Group-Regular FASD ServicesAttachment ClassificationDisordered (pretest)4 participants
Control Group-Regular FASD ServicesAttachment ClassificationSecure (post test)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAnxious-Insecure (post test)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAnxious-Avoidant (post test)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAvoidant (post test)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationDisordered (post test)1 participants
Control Group-Regular FASD ServicesAttachment ClassificationSecure (followup)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAnxioius-Insecure (followup)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAnxious-Avoidant (followup)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAvoidant (followup)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationDisordered (followup)1 participants
Control Group-Regular FASD ServicesAttachment ClassificationSecure (pretest)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAnxious-Insecure (pretest)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAnxious-Avoidant (pretest)0 participants
Control Group-Regular FASD ServicesAttachment ClassificationAvoidant (pretest)0 participants
Secondary

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)

Population: Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2

ArmMeasureGroupValue (MEAN)
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-D (post test)3.33 units on a scale
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-A (followup)4 units on a scale
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-A (pretest)4.13 units on a scale
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-S (pretest)7.63 units on a scale
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-D (followup)5.2 units on a scale
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-S (post test)6.17 units on a scale
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-A (post test)4.5 units on a scale
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-S (followup)9 units on a scale
Receives COS InterventionThe Depression Anxiety Stress Scale (DASS)DASS-D (pretest)2.63 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-S (followup)2 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-D (pretest)1 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-D (post test)0 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-D (followup)0 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-A (pretest)0.5 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-A (post test)0 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-A (followup)0 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-S (pretest)3 units on a scale
Control Group-Regular FASD ServicesThe Depression Anxiety Stress Scale (DASS)DASS-S (post test)4.5 units on a scale
Secondary

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)

Population: 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

ArmMeasureGroupValue (MEAN)
Receives COS InterventionThe Parenting Scale (TPS)TPS Verbosity (follow up)3.11 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Total (pretest)4.08 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Laxness (followup)2.47 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Overreactivity (pretest)2.39 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Laxness (post test)2.97 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Overreactivity (post test)2.18 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Overreactivity (follow up)2.46 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Total (post test)2.97 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Verbosity (pretest)3.54 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Verbosity (post test)3.56 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Total (followup)2.67 units on a scale
Receives COS InterventionThe Parenting Scale (TPS)TPS Laxness (pretest)3.22 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Verbosity (follow up)3.36 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Laxness (followup)2.46 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Overreactivity (post test)2.53 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Total (pretest)2.3 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Total (post test)3.27 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Laxness (pretest)2.22 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Laxness (post test)3.14 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Overreactivity (pretest)1.65 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Overreactivity (follow up)1.85 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Verbosity (pretest)2.80 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Verbosity (post test)3.52 units on a scale
Control Group-Regular FASD ServicesThe Parenting Scale (TPS)TPS Total (followup)2.6 units on a scale
Secondary

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)

ArmMeasureGroupValue (MEAN)
Receives COS InterventionThe Parenting Stress Index (PSI)PD (post test) n=6, n=127 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)PCDI (followup) n=5, n=227.8 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)DR (post test) n=6, 115.66 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)DC (pretest) n=8, n=435.75 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)PD (followup) n=5, n=233.4 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)DC (post test) n=6, n=133.66 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)PD (pretest) n=8, n=442.75 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)DC (followup) n=5, n=235.4 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)PCDI (pretest) n=8, n=437.5 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)PSI total Stress (pretest) n=8, n=4116 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)DR (followup) n=5, n=219 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)PSI total Stress (post test) n=6, n=186.33 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)PCDI (post test) n=6, n=125.66 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)PSI total Stress (followup) n=5, n=296.6 units on a scale
Receives COS InterventionThe Parenting Stress Index (PSI)DR (pretest) n=8, n=425.13 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PSI total Stress (followup) n=5, n=296.5 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)DR (pretest) n=8, n=414.25 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)DR (post test) n=6, 116 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)DR (followup) n=5, n=218 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PD (pretest) n=8, n=424 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PD (post test) n=6, n=129 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PD (followup) n=5, n=230.5 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PCDI (pretest) n=8, n=424.5 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PCDI (post test) n=6, n=131 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PCDI (followup) n=5, n=224 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)DC (pretest) n=8, n=440.75 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)DC (post test) n=6, n=156 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)DC (followup) n=5, n=242 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PSI total Stress (pretest) n=8, n=489.25 units on a scale
Control Group-Regular FASD ServicesThe Parenting Stress Index (PSI)PSI total Stress (post test) n=6, n=1116 units on a scale
Secondary

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)

Population: Please see category specific n values below.

ArmMeasureGroupValue (MEAN)
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-PS (post test) n=6, n=16.66 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-HA (followup) n=5, n=27.8 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-PS (followup) n=5, n=26.2 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-CP (post test) n=6, n=13.66 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQTotal SDQ (pretest)n=7, n=418.71 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ- PP (pretest) n=7, n=43 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQTotal SDQ (post test)n=6, n=118 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQTotal SDQ (followup) n=5, n=219.2 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-HA (pretest)n=6, n=48.17 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQTotal IS (pretest) n=7, n=44.43 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ- PP (post test)n=6, n=13.33 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQTotal IS (post test) n=6, n=12.12 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-CP (pretest) n=5, n=45 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQTotal IS (followup)n=5, n=03.4 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ- PP (followup)n= 5, n=22.8 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-ES (pretest) n=7, n=42.86 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-HA (post test) n=6, n=16.66 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-ES (post test) n=6, n=14.33 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-PS (pretest) n=7, n=45.86 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-ES (followup) n=5, n=23.8 units on a scale
Receives COS InterventionThe Strengths and Difficulties Questionnaire SDQSDQ-CP (followup) n=5, n=24.8 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-ES (followup) n=5, n=23 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-CP (pretest) n=5, n=44.5 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-CP (post test) n=6, n=17 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-CP (followup) n=5, n=24 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-HA (pretest)n=6, n=48 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-HA (post test) n=6, n=19 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-HA (followup) n=5, n=26.5 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ- PP (pretest) n=7, n=44 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ- PP (post test)n=6, n=16 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ- PP (followup)n= 5, n=23 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-PS (pretest) n=7, n=46 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-PS (post test) n=6, n=15 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-PS (followup) n=5, n=27 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQTotal SDQ (pretest)n=7, n=421 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQTotal SDQ (followup) n=5, n=216 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQTotal IS (pretest) n=7, n=45.5 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQTotal IS (post test) n=6, n=110 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQTotal IS (followup)n=5, n=0NA units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-ES (pretest) n=7, n=44.5 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQSDQ-ES (post test) n=6, n=13 units on a scale
Control Group-Regular FASD ServicesThe Strengths and Difficulties Questionnaire SDQTotal SDQ (post test)n=6, n=125 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026