NCT01483521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
Last Updated

December 1, 2011

Status Verified

November 1, 2011

Enrollment Period

1.7 years

First QC Date

November 24, 2011

Last Update Submit

November 30, 2011

Conditions

Keywords

RandomizedHome visitationExternalizing disorderParenting stressChildhood externalizing disordersPositional defiant

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Measurement of parental stress

    Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks

Study Arms (1)

Waitlist families

EXPERIMENTAL

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

Interventions

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.

Also known as: Home visiting, Externalizing disorders, Parenting stress
Waitlist families

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with externalizing disorders referred to Infant Psychiatry Clinic of Children's hospital and on the wait list

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

AggressionSpasmImpulsive Behavior

Interventions

House CallsPsychological Tests

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationBehavioral Disciplines and Activities

Study Officials

  • Pratibha Reebye

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2011

First Posted

December 1, 2011

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

December 1, 2011

Record last verified: 2011-11

Locations