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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Cont

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 Summary: See Arms and Intervention
Sponsor: University of Manitoba

Current Primary Outcome: Attachment Classification [ Time Frame: Administered 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.


Original Primary Outcome:

  • Change in the Parenting Scale [ Time Frame: 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 that will used to measure changes in parenting behaviours.
  • Change in the Parenting Stress Index [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ]
    A parent-report questionnaire of parental stress, parent-child interaction style, and difficult child behaviour that will be used to measure changes in parental stress.
  • Change in the Depression Anxiety Stress Scale [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ]
    A self-report measure of depression, anxiety, and stress that will be used to measure changes in parental depression and anxiety traits.
  • Change in the Strengths and Difficulties Questionnaire [ Time Frame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup) ]
    A parent-report measure that will be used to measure changes in the psychological adjustment of children.


Current Secondary Outcome:

  • The Parenting Scale (TPS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 SDQ [ Time Frame: Administered 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.


Original Secondary Outcome:

Information By: University of Manitoba

Dates:
Date Received: February 9, 2012
Date Started: March 2012
Date Completion:
Last Updated: August 16, 2016
Last Verified: August 2016