AzTrials
AzTrials

Fetal Alcohol Spectrum DisorderNCT01536184

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

A study testing Circle of Security (COS) in people with Fetal Alcohol Spectrum Disorder and Attachment Disorders, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 2 to 5 years
What is being tested?
Circle of Security (COS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
Mar 2012to Dec 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • FASD Outreach Program

    Winnipeg, Manitoba, R3N0H6

Other trials in Canada

About this study

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 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.

Read the detailed description

See Arms and Intervention

Being tested
Circle of Security (COS)
Keywords
Fetal Alcohol Spectrum Disorder, FASD
Medical subject headings
Fetal Alcohol Spectrum Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Circle of Security (COS)Behavioural

    Also called Attachment Intervention

    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.

Study groups in NCT01536184
Study groupRoleWhat they receive
Receives COS InterventionExperimentalCircle 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.
Receives: Behavioral: Circle of Security (COS)
Control Group-Regular FASD ServicesNo interventionRegular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Attachment Classification

    Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.

    Measured: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

Secondary outcomes (4)
  1. 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.

    Measured: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

  2. 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

    Measured: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

  3. 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.

    Measured: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

  4. 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.

    Measured: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionJan 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01536184
Sponsor's protocol ID
H2012:015
Status last verified
Aug 2016
First submitted
9 Feb 2012
Last updated
25 Aug 2016
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Circle of Security (COS) in people with Fetal Alcohol Spectrum Disorder and Attachment Disorders, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attachment Classification (time frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in