Clinical trial NCT01536184: Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorder
Attachment Disorders
Keywords: Fetal Alcohol Spectrum Disorder
FASD
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Attachment Classification
timeFrame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
Secondary outcomes:
measure: The Parenting Scale (TPS)
timeFrame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
measure: The Parenting Stress Index (PSI)
timeFrame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
measure: The Depression Anxiety Stress Scale (DASS)
timeFrame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
measure: The Strengths and Difficulties Questionnaire SDQ
timeFrame: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: FASD Outreach Program
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Ana Hanlon-Dearman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Services and Housing, Province of Manitoba
name: FASD Outreach
role: STUDY_CHAIR
affiliation: Government of Manitoba
name: Healthy Child Manitoba Office
role: STUDY_CHAIR
References: