AggressionNCT01483521
Infant Psychiatry Home Visitation Program
A study testing Clinical home visitation in people with Aggression and Hyperactivity, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Aggression, Hyperactivity, Impulsive Behaviors
- What is being tested?
- Clinical home visitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with externalizing disorders referred to Infant Psychiatry Clinic of Children's hospital and on the wait list
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program
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.
Read the 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.
- Conditions
- Aggression, Hyperactivity, Impulsive Behaviors
- Being tested
- Clinical home visitation
- Keywords
- Randomized, Home visitation, Externalizing disorder, Parenting stress, Childhood externalizing disorders, Positional defiant
- Medical subject headings
- Aggression, Spasm, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical home visitationOther
Also called Home visiting, Externalizing disorders, Parenting stress
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical home visitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measurement of parental stress after the intervention was offered
Measured: Participants will be followed for the duration of their time on the Clinic's wait list, an expected average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Childrens Hospital Foundation
- Responsible party
- Sponsor
- Investigators
- Pratibha Reebye, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483521
- Sponsor's protocol ID
- H08-02992
- Status last verified
- Nov 2011
- First submitted
- 24 Nov 2011
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Externalizing Behavior in Early Childhood: A Randomized Control Evaluation of a Home Visitation Program
- ClinicalTrials.gov ID
- NCT01483521
- Acronym / sponsor ID
- H08-02992
- Conditions
- Aggression, Hyperactivity, Impulsive Behaviors
- Keywords
- Randomized, Home visitation, Externalizing disorder, Parenting stress, Childhood externalizing disorders, Positional defiant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Childrens Hospital Foundation
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Waitlist families | Experimental | Other: Clinical home visitationExperimental 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. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with externalizing disorders referred to Infant Psychiatry Clinic of Children's hospital and on the wait list
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical home visitationAlso: Home visiting, Externalizing disorders, Parenting stressClinical 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 | Waitlist families |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pratibha Reebye principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical home visitation in people with Aggression and Hyperactivity, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2011.