Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000793011
Ethics application status
Approved
Date submitted
20/09/2010
Date registered
24/09/2010
Date last updated
9/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Child and Parents at Hospital: Improving Health and Well-being (The CAP@H project)
Scientific title
A sequential, comparison group pilot study investigating the feasibility and acceptability of a model of Enhanced Care compared to Usual Care for children (under 12 years of age) who have been assessed to have experienced cumulative stress and trauma and who are inpatients of an acute paediatric tertiary hospital.
Secondary ID [1] 252705 0
Nil
Universal Trial Number (UTN)
Trial acronym
The CAP@H Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cumulative stress and trauma arising from multiple co-existing and/or recurrent family stress in addition to childhood illness. 258197 0
Condition category
Condition code
Public Health 258373 258373 0 0
Health service research
Mental Health 258374 258374 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a sequential, comparision group design. In the first part of the study, a cohort will be recruited into a Usual Care group (n=25). The Usual Care group will be delivered standard care for children experiencing cumulative stress and trauma as a result of multiple co-existing and/or recurrent family stress in addition to childhood illness. The Usual Care group will complete standardised measures (at entry to study and 6 months post-discharge), participate in qualitative interviews (at discharge from hospital and 6 months post-discharge) and an audit of the child's medical file will be conducted (at discharge from hospital and 6 months post-discharge).

In the second part of the study, a second cohort will be recruited into an Enhanced Care group (n=25).

The Enhanced Care cohort will receive the following intervention:
1) A comprehensive psycho-social assessment conducted by the Hospital Social Work Department. This assessment will assess the following domains: family history; family functioning; personal history of parent/s; child’s developmental history; parent-child relationship; family networks and supports including past Department of Human Services (DHS) - Child Protection involvement. The assessment will be conducted by interviewing the parents of the child, and the child, as appropriate. The assessment will be conducted within 24 hours of recruitment to the study (approximately sixty to ninety minutes duration).


2) A comprehensive medical and developmental assessment conducted by forensic paediatric specialists within 24 hours of recruitment to the study. The assessment will include both an interview with parents and medical/developmental assessment of the child (approximately sixty to ninety minutes in duration).

3) The comprehensive psychosocial assessment and the comprehensive medical and developmental assessment wil be discussed in a multi-disciplinary evaluation and planning meeting attended by Unit medical, nursing and allied health staff as well that the specialist from the Victorian Forensic Paediatric Medical Service who conducted the comprehensive medical and developmental assessment and the social worker who conducted the comprehensive psychosocial assessment (approximately 30-45 minutes duration).

4) The recommendations of the multi-disciplinary evaluation and planning meeting will be discussed with the family in a formal family case planning meeting where a individualised plan for the child and family will be devised (approximately sixty to ninety minutes duration).

The Enhanced Care group will complete standardised measures (at entry to study and 6 months post-discharge), participate in qualitative interviews (at discharge from hospital and 6 months post-discharge) and an audit of the child's medical file will be conducted (at discharge from hospital and 6 months post-discharge).

The overall duration of the study will be 12 months to 18 months, dependent on the recruitment rate.
Intervention code [1] 257212 0
Prevention
Intervention code [2] 257213 0
Other interventions
Comparator / control treatment
Standard treatment for children who have experienced cumulative stress and trauma is not subject to consistent model of care to guide assessment and intervention.

Thus, standard care varies on a case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 259216 0
The feasibility and acceptability of the model of Enhanced Care from both a parent and a staff perspective.

The impact of cumulative stress and trauma manifests in compromised health and well-being that may impact on the child's cognitive, educational, social, physical and emotional development and functioning. We will be measuring these variables at baseline and at 6 months post-discharge for both the Usual Care and the Enhanced Care groups. These variables will be measured via a questionnaire that incorporates a number of standardised measures of child and family health and well-being.

A medical file audit will be conducted to identify the features of Usual Care as well as, for both the Usual Care and the Enhanced Care group, the family engagement in health services (i.e. attendance at outpatient appointments, further contact with the Hospital, referrals to specialist care which are implemented) and health outcomes for the child .

The findings of the qualitative interviews with parents, at discharge from hospital and 6 months post-discharge, will give us data about what parents found was helpful and what was not helpful during their child?s hospital admission as well as their suggestions about what else would be helpful. We will have this feedback from both the Usual Care and Enhanced Care group.

Staff consultations and focus groups will be held to review and refine the current proposed model of Enhanced Care prior to model being trialled.
Timepoint [1] 259216 0
Six months post-discharge from hospital
Primary outcome [2] 259217 0
Describe how the study population compares to community groups on measures of child and family health and well-being (using data from the Growing Up in Australia: The Longitudinal Study of Australian Children, Australian Institute of Family Studies)
Timepoint [2] 259217 0
During admission and at 6 months post-discharge
Primary outcome [3] 259218 0
Health and well-being of child and families in Enhanced Care compared to Usual Care group.

The impact of cumulative stress and trauma manifests in compromised health and well-being that may impact on the child's cognitive, educational, social, physical and emotional development and functioning. We will be measuring these variables at baseline and at 6 months post-discharge for both the Usual Care and the Enhanced Care groups. These variables will be measuresd via a questionnaire that incorporates a number of standardised measures of child and family health and well-being.

The audit of the medical files of children in both the Usual Care and the Enhanced Care group will provide data about 1) previous presentations to the hospital (both for inpatient and ambulatory care)
2) assessments of the clinical team during the child's inpatient admission (in which they are recruited to the study)
3) data about attendance at scheduled appointments post-discharge from hospital.
Timepoint [3] 259218 0
Six months post-discharge from hospital
Secondary outcome [1] 265622 0
Explore the acceptability of measures included in the CAP@H questionnaire to study participants (parents of children expoesd to cumulative stress and trauma).

During the qualitative interviews with parents at discharge from hospital and six months post-discharge, we will ask participants about their experience of participating in the research project including the completion of the study questionnaire.
Timepoint [1] 265622 0
At discharge from hospital and six months post-discharge from hospital.
Secondary outcome [2] 265623 0
Determine what outcomes measures should be used to measure the impact of this intervention in further trials.

We will compare the Usual Care Group and the Enhanced Care Group on all measures at six-month post-discharge using Pearson Chi Square or Fisher's Exact Test for categorical data and analysis of variance (ANOVA) for continuous data. An examination of the distribution of raw scores may suggest a trend indicating which domains may have been impacted on, and on which domains there appears to be no difference between the Usual Care Group and the Enhanced Care Group. This analysis will give an indication of the most appropriate study outcomes to use in further trials.
Timepoint [2] 265623 0
Six months post-discharge from hospital.
Secondary outcome [3] 265624 0
Compare outcomes in terms of child and family health and well being between the enhanced care and usual care groups in order to make an estimation of the variability in outcomes between the enhanced care and usual care groups to help determine sample size for future trials.

The impact of cumulative stress and trauma is manifested in compromised health and well-being that may impact on the child's cognitive, educational, social, physical and emotional development and functioning. We will be measuring these variables at baseline and at 6 months post-discharge for both the Usual Care and the Enhanced Care groups. These variables will be measured via a questionnaire that incorporates a number of standardised measures of child and family health and well-being.
Timepoint [3] 265624 0
Six months post-discharge from hospital.
Secondary outcome [4] 265646 0
Explore the acceptability and feasibility of the overall research design for populations similar to the project's study population.

During interviews with parents at discharge from hospital and six months post-discharge, we will ask participants about their experience of participating in the research project and on the completion of the questionnaires.

We will also document difficulties experienced in recruitment and monitor retention rates.
Timepoint [4] 265646 0
Throughout the study ie recruitment sucess, retention at discharge from hospital and 6 months post discharge.

Eligibility
Key inclusion criteria
1. Children admitted to select medical Units of the Royal Children's Hospital, Melbourne, Victroia, Australia
2. Assessed by Unit medical, nursing or social work staff to be at risk of experiencing the impact of cumulative stress or trauma
Minimum age
0 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children identified as Aboriginal and Torres Strait Island descent.
2. Children who are current clients of Department of Human Services (DHS) - Child Protective Services
3. Parents unable to consent due to cognitive impairment
4. Parents under the age of 18
5. Parent who are unable to consent due to psychiatric illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sequential comparison group design.

In the first part of the project, the first cohort participants will receive usual care (n=25).

In the second part of the study, a second cohort of participants will receive the Enhanced Care model.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257662 0
Government body
Name [1] 257662 0
Australian Research Council - Linkage Grant LP0883427
Country [1] 257662 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital, Melbourne, Australia
Address
Departments of Social Work, General Medicine & Victorian Forensic Paediatric Medical Service
Royal Children's Hospital
Flemington Road
Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 256878 0
University
Name [1] 256878 0
The University of Melbourne
Address [1] 256878 0
Melbourne School of Health Sciences & Department of Paediatrics
The University of Melbourne
Level 5, 234 Queensberry Street,
Carlton VIC 3010
Country [1] 256878 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259680 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 259680 0
Ethics committee country [1] 259680 0
Australia
Date submitted for ethics approval [1] 259680 0
Approval date [1] 259680 0
07/09/2010
Ethics approval number [1] 259680 0
30076A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31650 0
Address 31650 0
Country 31650 0
Phone 31650 0
Fax 31650 0
Email 31650 0
Contact person for public queries
Name 14897 0
Professor Cathy Humphreys
Address 14897 0
The University of Melbourne
Melbourne School of Health Sciences (Department of Social Work)
Level 5, 234 Queensberry Street
Carlton VIC 3010
Country 14897 0
Australia
Phone 14897 0
+61 3 83449427
Fax 14897 0
Email 14897 0
[email protected]
Contact person for scientific queries
Name 5825 0
Associate Professor Brigid Jordan
Address 5825 0
Social Work Department
Royal Children's Hospital
4th Floor, Front Entry Building
50 Flemington Road
Parkville VIC 3052
Country 5825 0
Australia
Phone 5825 0
+61 03 9345 4144
Fax 5825 0
Email 5825 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.