Infant Psychiatry Home Visitation Program

Aggression Clinical Trial

Official title:

Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483521
• Other study ID #: H08-02992
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: November 30, 2011
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Hyperactivity
• Impulsive Behavior
• Impulsive Behaviors

Intervention

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.

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Childrens Hospital Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks	No
Secondary	Measurement of parental stress	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	No