Infant Psychiatry Home Visitation Program
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01483521|
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : December 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Aggression Hyperactivity Impulsive Behaviors||Other: Clinical home visitation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||February 2011|
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.
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483521
|Canada, British Columbia|
|British Columbia Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Pratibha Reebye||University of British Columbia|