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Infant Psychiatry Home Visitation Program

Primary Purpose

Aggression, Hyperactivity, Impulsive Behaviors

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Clinical home visitation
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggression focused on measuring Randomized, Home visitation, Externalizing disorder, Parenting stress, Childhood externalizing disorders, Positional defiant

Eligibility Criteria

undefined - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • British Columbia Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Waitlist families

Arm Description

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.

Outcomes

Primary Outcome Measures

Reduction of externalizing disorders and child's aggression
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

Measurement of parental stress
Measurement of parental stress after the intervention was offered

Full Information

First Posted
November 24, 2011
Last Updated
November 30, 2011
Sponsor
University of British Columbia
Collaborators
British Columbia Childrens Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01483521
Brief Title
Infant Psychiatry Home Visitation Program
Official Title
Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
British Columbia Childrens Hospital Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression, Hyperactivity, Impulsive Behaviors
Keywords
Randomized, Home visitation, Externalizing disorder, Parenting stress, Childhood externalizing disorders, Positional defiant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist families
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Clinical home visitation
Other Intervention Name(s)
Home visiting, Externalizing disorders, Parenting stress
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of externalizing disorders and child's aggression
Description
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).
Time Frame
Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks
Secondary Outcome Measure Information:
Title
Measurement of parental stress
Description
Measurement of parental stress after the intervention was offered
Time Frame
Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pratibha Reebye
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada

12. IPD Sharing Statement

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Infant Psychiatry Home Visitation Program

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