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Infant Psychiatry Home Visitation Program

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ClinicalTrials.gov Identifier: NCT01483521
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : December 1, 2011
Sponsor:
Collaborator:
British Columbia Childrens Hospital Foundation
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE November 24, 2011
First Posted Date  ICMJE December 1, 2011
Last Update Posted Date December 1, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infant Psychiatry Home Visitation Program
Official Title  ICMJE Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aggression
  • Hyperactivity
  • Impulsive Behaviors
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Other: Clinical home visitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2011)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01483521
Other Study ID Numbers  ICMJE H08-02992
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE British Columbia Childrens Hospital Foundation
Investigators  ICMJE
Principal Investigator: Pratibha Reebye University of British Columbia
PRS Account University of British Columbia
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP