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Infant Psychiatry Home Visitation Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01483521
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : December 1, 2011
British Columbia Childrens Hospital Foundation
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
This is a proposed home visitation program for families of children with externalizing behaviors who are on the wait list for psychiatric assessment at BC Children's hospital. The aim of this program is to implement and evaluate a home visitation strategy in order to support those waiting up to four months to consult a psychiatrist.

Condition or disease Intervention/treatment Phase
Aggression Hyperactivity Impulsive Behaviors Other: Clinical home visitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

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.

Other: Clinical home visitation
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:
  • Home visiting
  • Externalizing disorders
  • Parenting stress

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01483521

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Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
British Columbia Childrens Hospital Foundation
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Principal Investigator: Pratibha Reebye University of British Columbia
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Responsible Party: University of British Columbia Identifier: NCT01483521    
Other Study ID Numbers: H08-02992
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: December 1, 2011
Last Verified: November 2011
Keywords provided by University of British Columbia:
Home visitation
Externalizing disorder
Parenting stress
Childhood externalizing disorders
Positional defiant
Additional relevant MeSH terms:
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Impulsive Behavior
Behavioral Symptoms