Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000844741
Ethics application status
Approved
Date submitted
24/07/2013
Date registered
31/07/2013
Date last updated
14/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A mixed methods trial of a family-based, parent-led intervention to improve resilience and wellbeing of families living with a childhood chronic illness.
Scientific title
Improving the well-being and resilience of families of children and adolescents living with a chronic illness: an examination of the efficacy and acceptability of a stepped-care family resilience intervention, compared to standard mental helath promotion practices at one paediatric hospital in Australia.
Secondary ID [1] 282433 0
Nil
Universal Trial Number (UTN)
U1111-1142-8829
Trial acronym
CHIRP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 289048 0
Family resilience 289049 0
Chronic illness 289580 0
Condition category
Condition code
Mental Health 289389 289389 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 289915 289915 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Step 1: Routine dissemination INTERVENTION: Family Resilience and Well-being Fact Sheet EXPOSURE: Parents whose child/young person is discharged from the paediatric hospital will receive a mental health promotion message and brief Family Resilience and Wellbeing Fact Sheet. All parents receive this brief resource as part of an existing paediatric administrative discharge procedure. This level of the project involves working in collaboration with the hospital to introduce and consolidate a method of standardised care procedure concerning provision of family resilience and well-being information to paediatric patients and families. Step 2: Targeted dissemination INTERVENTION: Family Resilience and Well-being Booklet EXPOSURE: Parents whose child attends selected Outpatient Clinics at the paediatric hospital and who consent to participate in the project will receive a Family Resilience and Well-being booklet. The booklet is a self-directed workbook primarily aimed at parents, based on a behaviour change model. The booklet contains information and activities designed to improve well-being and resilience of parents and family members, including children with chronic illness and their siblings. Step 3: Active dissemination INTERVENTION: Parent/Carer Information Support Group EXPOSURE: Parents who participate in Step 2 (Booklet intervention) and are identified as experiencing psychological distress, will be invited to attend a parent information and support group. Content of the group sessions will be based on the Family Resilience and Well-being booklet and will provide the additional benefit of an opportunity for discussion and practice of the strategies within a facilitated, interactive peer-supported environment. The information and support groups will be conducted over six weeks. In week one participants will attend a full day session during which they will have the opportunity to connect with other parents, share their experience and interact with the facilitators to engage with the material in the Family Resilience and Well-being booklet. There will be two group facilitators and up to 15 participants per group. A session attendance list will be completed by facilitators and participants to record attendance. Over weeks two to five, material pertaining to family resilience strategies will be posted once a week onto an online forum by a research team member who will act as moderator of the site. Participants will be encouraged to read the material, engage in the activity with their family, and post their comments for group online discussion. In week six, a final session will provide an opportunity for parents to meet face-to-face to discuss their experiences, review their participation in the program, identify ongoing social supports and complete a program evaluation and the primary outcome measures.
Intervention code [1] 287083 0
Prevention
Intervention code [2] 287084 0
Treatment: Other
Comparator / control treatment
Steps 1 and 2 are uncontrolled, in that all participants receive the intervention in these phases of the project. Step 3 will involve a randomised waitlist control group. On recruitment, 50% of participants will be randomly allocated to an intervention condition and 50% will be allocated to a waitlist control condition. The intervention condition treatment will involve participating in a scheduled Information Support Group. The control treatment will involve receipt of the Family Resilience and Well-being booklet only and standard mental health promotion practices of the Outpatient Clinic healthcare teams. After data collection, participants in the waitlist control condition will proceed to complete an Information Support Group intervention.
Control group
Active

Outcomes
Primary outcome [1] 289499 0
Family resilience and well-being will be measured as a number of constructs that contribute to the process of coping and adapting to stressful life events. The CHiRP Parent Outpatient Survey includes three standardised tests of these relevant constructs; psychological distress, family functioning and social support.

Primary Outcome 1 is the Kessler Psychological Distress Scale (K10). This standardised questionnaire is a screening tool to assess distress and the likelihood of a mental disorder in the responding individual. Higher scores indicate higher levels of distress. This measure will provide an indication of parental psychological distress.
Timepoint [1] 289499 0
Baseline, 3 months post intervention and 6 months post intervention.
Primary outcome [2] 290106 0
Primary Outcome 2 is the McMasters Family Assessment Device (v3). This standardised questionnaire provides a measure of family functioning, including problem solving, communication, roles, affective responsiveness, affective involvement, behaviour control and overall general functioning. Lower scores indicate healthier functioning.
Timepoint [2] 290106 0
Baseline, 3 months and 6 months post intervention
Primary outcome [3] 290107 0
Primary Outcome 3 is the Medical Outcomes Study Social Support Survey. This instrument measures perceived availability of support including emotional/informational support, tangible support, affectionate support and positive social interaction. A higher score indicates higher support.
Timepoint [3] 290107 0
Baseline, 3 months and 6 months post intervention.
Secondary outcome [1] 302621 0
Process evaluation of the Information Support Group will be conducted using an evaluation questionnaire, completed by participants in the last session of the group, in addition to the primary outcome measures. The evaluation questionnaire has been purposely designed for this trial and data collected will inform the acceptability and utility of the program for participants.
Timepoint [1] 302621 0
Post intervention

Eligibility
Key inclusion criteria
Step 1: Routine dissemination group.
Step 1 of the project involves all parents/carers of children and young people who are discharged from the paediatric hospital. While the pilot aims to promote family resilience and well-being in families who have a child/young person living with chronic illness, this level of the pilot aims to provide broader benefit to all families visiting the hospital by facilitating access to mental health promotion and prevention information to all families regardless of the child or young person's diagnosis.

Step 2: Targeted Dissemination group.
Step 2 of the project involves consenting parents/carers whose child/young person is attending one of the four selected outpatient clinics at the paediatric hospital (Gastroenterology, Cystic Fibrosis, Diabetes and Rheumatology).

Step 3: Active dissemination phase.
Step 3of the project involves consenting parents/carers whose child/young person is attending one of the four selected outpatient clinics at the paediatric hospital (Gastroenterology, Cystic Fibrosis, Diabetes and Rheumatology), and who score mild, moderate or severe psychological distress according to standard clinical cut off scores on the Kessler Psychological Distress (K10) Scale.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Step 1: Routine dissemination (Fact Sheet Intervention). Children and young people under the age of 18 years.

Step 2: Targeted dissemination (Booklet Intervention).
Children and young people under the age of 18 years.

Step 3: Active dissemination (Information Support Group Intervention).
Children and young people under the age of 18 years AND parents/carers who score <15 on the Kessler Psychological Distress (K10) Scale.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Step 1: Routine dissemination (Fact Sheet Intervention).
Step 1of the project is uncontrolled. All parents/carers of children/young people discharged from the paediatric hospital will recive a Family Resilience and Well-being Fact Sheet.
Step 2 (Booklet Intervention): Targeted dissemination.
Step 2 of the project is uncontrolled. All parents/carers of children/young people who attend the selected outpatient clinics at the paediatric hospital over the recruitment period will be invited to participate in the project and on consent will complete the Parent Outpatient Survey and recieve the Family Resilience and Well-being booklet.
Step 3: Active dissemination (Information Support Group Intervention).
Parents/Carers who score above normal on the Kessler Psychological Distress Scale (scores above 15) in Step 2 at three-month follow up will be eligible to participate in Step 3. At the time of assessing eligibility for the information support group (i.e. reviewing K10 scores to see if >15), the research team member will not be aware at the time of review whether the subject will be allocated to the group or waitlist condition. Eligible participants will be phoned by a project officer and invited to participate in the Information Support Group. Once all eligible participants are identified, allocation to the group or waitlist condition will be concealed using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the group or waitlist condition will be randomised using a randomisation table created by standard statistical computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Step 1: Routine dissemination (Fact Sheet Intervention) is Single Group Assignment. All participants receive the Family Resilience and Well-being Fact Sheet throughout the study. Step 2: Targeted dissemination (Booklet Intervention) is Single Group Assignment. All participants receive the Fact Sheet and the Family Resilience and Well-being booklet throughout the study. Step 3: Active dissemination (Information Support Group Intervention) is Parallel Assignment. Participants in Step 3 receive the Family Resilience and Well-being Booklet AND the Parent/Carer Information Support Group intervention during the same time span of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
In Step 1, it is expected that the Fact Sheet will be provided to 1050 parents of children discharged from paediatric hospital services based on an estimate of inpatient numbers over a 12-month period in 2011. There will be no direct data collection from this group.

A sample size calculation was conducted to guide recruitment for Step 2, the booklet intervention. A minimum sample of 98 participants at the three-month follow up assessment will have sufficient power (0.8) to detect a significant difference between mean scores (using alpha 0.05) in a one-sample comparison of baseline and three month follow-up data. A larger sample size will be recruited, however, to allow for attrition and sufficient numbers of participants eligible for Step 3.

In Step 3, the Parent Information Support Group intervention, using a randomised waitlist control design, the sample size will be divided randomly and equally between the group condition and the waitlist control condition. A sample size of approximately 120 (60 per group) participants at the three month follow up assessment will allow detection of a significant difference between mean scores using an alpha level of 0.05 in a two-sample comparison of the group condition and control condition on the outcomes measures, with a power of at least 0.8.

Statistical analyses:
Step 1 Routine dissemination (Fact Sheet Intervention).
Descriptive statistics only will be used to describe the reach of the factsheet; and whether participants in Step 2 and Step 3 recall receiving the factsheet.

Step 2 Targeted dissemination (Booklet Intervention).
Using oneway analyses of variance (ANOVA), the relationship between demographic data (e.g. gender, age categories, ethnicity, socioeconomic level, help-seeking behaviour categories) and baseline outcome measures will be explored.

The impact of the booklet intervention will be examined using analysis of covariance (ANCOVA) to compare changes in mean scores from baseline to three-month follow-up on the outcome measures for all participants in Step 2 (n ˜ 350). To test for sustained change, a second analysis of the Step 2 participants will use a repeated measures mixed model to compare mean scores on outcome measures at baseline, three and six month follow-up for the participants who did not move into Step 3 (the Information Support Group Intervention phase). Further analyses will adjust for baseline characteristics to control for any confounding effects.
Step 3 Active dissemination (Information Support Group Intervention).
Initial analyses will use demographic data to compare the characteristics of participants who agree to participate in Step 3 compared to those who decline to participate in this step of the project (despite meeting eligibility criteria, i.e. K10>15). Differences in responses according to demographic variables on the construct measures of interest (K10, FAD, family belief systems and MOS SSS) will also be analysed using oneway ANOVAs.

To examine the additional impact of the information support group intervention, relative to the wait-list control group (who will have only received the booklet intervention), an analysis of covariance will examine changes in mean scores on the outcome measures from baseline to post-intervention follow-up according to Group (n˜60) versus Waitlist (n˜60) allocation. To account for participant deviations from the protocol (such as dropout or failure to sufficiently participate in the group intervention), two analyses will be conducted. Data will be analysed using the intention-to-treat principle, which will assume all participants randomised to the intervention or waitlist group completed the study as per the research design and a per-protocol analysis will include only those participants who participate in a minimum of two-thirds of the intervention. Following post-intervention follow-up data collection, the waitlist group will complete the information support group intervention, and complete the post-intervention follow up. All group-based intervention participants will complete a six-month follow-up assessment. Thus, to test for sustained change, a second analysis will compare mean scores at baseline, post-intervention and six-month follow up on the same outcome measures for all participants in Step 3 of the intervention (n˜120). There will be no treatment allocation variable in this second analysis. Further analyses will adjust for baseline characteristics to control for any confounding effects.
Additional analyses will identify risk and protective factors on each construct measure (for example, scoring above 15 on the K10) at baseline for Group and Waitlist participants, and include comparisons for participants who agree to participate in Step 3 of the intervention and attend the Information Support group, compared to those who decline to participate in this step of the project, despite meeting eligibility criteria.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2013
Actual
2/09/2013
Date of last participant enrolment
Anticipated
31/10/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
353
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 977 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 6869 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 287250 0
Charities/Societies/Foundations
Name [1] 287250 0
Greater Charitable Foundation
Country [1] 287250 0
Australia
Primary sponsor type
Other
Name
Hunter New England Local Health District / Hunter Institute of Mental Health
Address
James Fletcher Hospital
72 Watt Street
PO Box 833
Newcastle NSW 2300
Country
Australia
Secondary sponsor category [1] 286001 0
University
Name [1] 286001 0
University of Newcastle
Faculty of Health
School of Medicine and Public Health
Address [1] 286001 0
Callaghan Campus
University Drive
Callaghan NSW 2308
Country [1] 286001 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289230 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 289230 0
Hunter New England Research Ethics & governance Unit
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 289230 0
Australia
Date submitted for ethics approval [1] 289230 0
20/03/2013
Approval date [1] 289230 0
03/04/2013
Ethics approval number [1] 289230 0
13/03/20/4.06
Ethics committee name [2] 289640 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 289640 0
Research Services
Research Integrity Unity
The Chancellery
University Drive
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [2] 289640 0
Australia
Date submitted for ethics approval [2] 289640 0
17/05/2013
Approval date [2] 289640 0
21/05/2013
Ethics approval number [2] 289640 0
H-2013-0157

Summary
Brief summary
Children who live with a chronic illness and their families face a multitude of challenges and are often more vulnerable to mental illness due to persistent levels of stress experienced in relation to the illness and other issues. The Child Illness and Resilience Project (CHiRP) aims to develop and evaluate the acceptability and effectiveness of a family resilience based mental health promotion intervention designed to enhance the well-being of this vulnerable population.

The testable hypotheses are;

1. that the provision of a Family Resilience and Well-being booklet containing information, strategies and self-directed activities designed to promote family resilience to parents/carers of children with a chronic illness will improve psychological well-being and family resilience (as measured by scores on standardised measures of relevant constructs such as psychological distress, family functioning, social connectedness, family beliefs and help-seeking behaviours);

2. that for parents/carers of children with a chronic illness who experience above normal levels of psychological distress, participation in an Family Resilience Information Support Group will further improve psychological well-being and family resilience (as measured by scores on standardised measures of relevant constructs such as psychological distress, family functioning, social connectedness, family beliefs and help-seeking behaviours), relative to receiving the booklet only.

3. that the CHiRP Family Resilience resources build the capacity of the health sector to standardise provision of information, support and resources to families who have a child with chronic illness (as measured by evaluation data from participants and health sector staff).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39742 0
Mr Todd Heard
Address 39742 0
Hunter Institute of Mental Health
James Fletcher Hospital
72 Watt Street
(PO Box 833)
Newcastle NSW 2300
Country 39742 0
Australia
Phone 39742 0
61 02 49246900
Fax 39742 0
61 02 4924 6724
Email 39742 0
Todd.Heard@hnehealth.nsw.gov.au
Contact person for public queries
Name 39743 0
Ms Katrina Hamall
Address 39743 0
Hunter Institute of Mental Health
James Fletcher Hospital
72 Watt Street
(PO Box 833)
Newcastle NSW 2300
Country 39743 0
Australia
Phone 39743 0
61 02 49246900
Fax 39743 0
61 02 49246724
Email 39743 0
Katrina.Hamall@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 39744 0
Dr Frances Kay-Lambkin
Address 39744 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country 39744 0
Australia
Phone 39744 0
61 02 93850333
Fax 39744 0
61 02 93850222
Email 39744 0
f.kaylambkin@unsw.edu.au

No information has been provided regarding IPD availability


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Results publications and other study-related documents

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