- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483521
Infant Psychiatry Home Visitation Program
Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Home visitation program was developed in response to long wait lists for the Infant Psychiatry Program. This home visitation program intervention consists of the following components: Developmental guidance, empowerment of parents while respecting the parent-child attachment, and child centered interactional guidance. The home visitors ( a PhD student and a Masters level student) visit consenting families and gave the parents an opportunity to voice their concerns regarding their child's behaviors. They were instructed to co-construct a play that had to be child led. Home visitors facilitated this task. Parents completed the Child Behavior Checklist and Parenting Stress Index prior to and after the intervention. These home visitations occurred approximately once a month whilst the families were on the wait list for clinical assessment and treatment. Those families that were randomized in control group did not receive any intervention.
Extended description of the protocol, including information not already contained in other fields.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3N1
- British Columbia Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with externalizing disorders referred to Infant Psychiatry Clinic of Children's hospital and on the wait list
Exclusion Criteria:
- Children over 6 years old
- Children with internalizing disorder
- Families that reside outside of the Vancouver due to practicality of home visitation,
- Families requiring an interpreter
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Waitlist families
Experimental arm consisted of randomized waitlist families who received home visitation where mothers were taught to play with their children in a developmentally appropriate manner and also engaged in a co-construction task. Control arm families did not get any active intervention. Parents from both arm types completed pre and post questionnaires to measure child's externalizing behaviors and parenting stress. Parents from experimental group were encouraged to keep a diary of their play record. |
Clinical Home visitation consisted of once a month visits to families on the experimental group.
During those visits home visitors facilitated developmentally appropriate play guidance and co-construction tasks for the dyad.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction of externalizing disorders and child's aggression
Time Frame: Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks
|
The specific units of measure to be assessed pre and post intervention are the mean scores of the CBCL (overall score, attention problems subscale, externalizing subscale, aggression subscale) and the PSI (overall score, parent distress sub scale, parent-child dysfunctional interaction, difficult child subscale).
|
Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of parental stress
Time Frame: Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks
|
Measurement of parental stress after the intervention was offered
|
Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pratibha Reebye, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H08-02992
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