Infant Psychiatry Home Visitation Program

This study has been completed.
Sponsor:
Collaborator:
British Columbia Childrens Hospital Foundation
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01483521
First received: November 24, 2011
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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 Intervention
Aggression
Hyperactivity
Impulsive Behaviors
Other: Clinical home visitation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks ] [ Designated as safety issue: No ]
    Measurement of parental stress after the intervention was offered


Enrollment: 40
Study Start Date: April 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483521

Locations
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
Investigators
Principal Investigator: Pratibha Reebye University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01483521     History of Changes
Other Study ID Numbers: H08-02992
Study First Received: November 24, 2011
Last Updated: November 30, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Randomized
Home visitation
Externalizing disorder
Parenting stress
Childhood externalizing disorders
Positional defiant

Additional relevant MeSH terms:
Aggression
Hyperkinesis
Impulsive Behavior
Behavioral Symptoms
Dyskinesias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014