N/A
N=12
Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
Fetal Alcohol Spectrum Disorder · Attachment Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01536184 ↗Enrolled (actual)
12
Serious AEs
—
Results posted
Aug 2016
Primary outcome: Primary: Attachment Classification — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Circle of Security (COS) (Behavioral)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Manitoba
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attachment Classification |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The Parenting Scale (TPS) |
4.08; 2.3; 2.97; 3.27; 2.67; 2.6 | — |
| SECONDARY The Parenting Stress Index (PSI) |
25.13; 14.25; 15.66; 16; 19; 18 | — |
| SECONDARY The Depression Anxiety Stress Scale (DASS) |
2.63; 1; 3.33; 0; 5.2; 0 | — |
| SECONDARY The Strengths and Difficulties Questionnaire SDQ |
2.86; 4.5; 4.33; 3; 3.8; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01536184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.