Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001729415
Ethics application status
Approved
Date submitted
12/12/2016
Date registered
16/12/2016
Date last updated
16/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Evaluation of a Facilitated Peer Support Program for Parents and Carers of Children with Disabilities
Scientific title
Outcomes Associated with Involvement in a Facilitated Peer Support Program for Parents and Carers of Children with Disabilities: Impacts on Parental Self-Efficacy, Social Support and Well-being
Secondary ID [1] 290731 0
None
Universal Trial Number (UTN)
U1111-1190-8553
Trial acronym
MyTime CQI and Outcomes Evaluation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental Delay 301309 0
Intellectual Disability 301310 0
Autism Spectrum Disorder 301311 0
Condition category
Condition code
Mental Health 301062 301062 0 0
Learning disabilities
Mental Health 301063 301063 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MyTime is a national program of facilitated peer support groups for parents and carers of children with a disability, developmental delay or chronic medical condition. Parents or caregivers with a child up to age 16 may attend a MyTime group if they are eligible to apply for the Carer Allowance. Each MyTime group consists of 4-12 parents, a facilitator to manage group processes, and at least one play helper who keeps children up to school age engaged in appropriate activities to support parent participation in the groups.

MyTime was established in 2007 and is funded by the Australian Department of Social Services (DSS) under the ‘Families and Children’ program. The Parenting Research Centre (PRC) manages the MyTime program across Australia, delivering implementation support to a network of 14 partner agencies at a regional level. Those agencies coordinate local providers to deliver the MyTime groups (currently 213 groups nationally). Approximately 3000 parents and carers attend at least one MyTime group each year.

The content and delivery of individual MyTime group sessions are determined at a local level and guided by parent/carer need though typically structured around one or more of the following types of activities:
1. Topic based discussion (facilitated and based on resources provided)
2. Guest speakers including services information sessions
3. Pampering & bonding activities or excursions
4. Appropriate play activities for children and siblings.

Topics frequently covered in groups include parent and carer self-care, available services or supports, parenting issues e.g., managing behaviour, eating, child development, the National Disability Insurance Scheme (NDIS), schools/education. Evidence-based information on each of these topics is provided to facilitators to support these discussions by the Parenting Research Centre. Information regarding specific content areas and activities conducted in each session is currently collected by the Parenting Research Centre, with the proposed evaluation aiming to gather more detailed information about the fidelity of delivery to the program model across individual groups.

MyTime groups are typically delivered on a fortnightly basis for a period of at least two hours. Some groups offer weekly sessions. Parents participate in as many or as few sessions as they wish. Information regarding the frequency and duration of MyTime sessions for individual participants will be collected and included in analyses of outcomes. For the purposes of the current evaluation, the intervention period will be six months. Six months was identified as being a reasonable timeframe for collecting follow-up or ‘post-test’ data as most parents would have participated in a minimum of 12 sessions during this period which was considered adequate program ‘dosage’ for parents to experience intended proximal outcomes (i.e., increased social support, increased knowledge of services and supports, increased parent knowledge and skills, reduced stress etc.).

Program facilitators have relevant qualifications in psychology, social work or welfare and receive training and ongoing professional development to facilitate the program. All facilitators receive support through a local MyTime co-ordinator and have access to evidence-based resources for facilitators provided by the Parenting Research Centre.

The MyTime practice model is based on research which suggests that peer support programs can provide a range of benefits to parents of children with a disability or chronic medical condition. These include increased parental sense of agency and control, increased social support, reduced stigma and reduced stress, depression and anxiety (e.g., Armstrong, Birnie-Lefcovitch, & Ungar, 2005; Bottrell, 2009; Campbell, Phaneuf & Deane, 2004; Shilling et al., 2013). These benefits align strongly with the needs expressed by parents and carers of children with a disability including accessing additional information, advice and links to appropriate resources and support, having an outlet to express thoughts and feelings without judgement, accessing increased social support and gaining a sense of control (e.g., Attride-Stirling et al., 2000; Hogan, 2002).

On the basis of this research, the main objectives of MyTime are to:
1. Increase parents’ and carers’ social support
2. Increase parental knowledge of caring for a child with special needs
3. Reduce parental stress.
Intervention code [1] 296632 0
Behaviour
Intervention code [2] 296685 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300484 0
Proportion of participants who experience increased social support (emotional, informational/ guidance, practical): Measured by tool adapted from Wynter et al., 2014
Timepoint [1] 300484 0
Pre-program and at six-months following program enrolment
Primary outcome [2] 300485 0
Proportion of participants with increased knowledge of local services and supports: Measured by tool developed specifically for current evaluation (based on DSS SCORE outcomes)
Timepoint [2] 300485 0
Pre-program and at six-months following program enrolment
Primary outcome [3] 300486 0
Proportion of participants with increased parenting confidence and skills: Measured using Self-Efficacy Subscale of the Me as a Parent Scale (MaaP; Hamilton, Matthews, & Crawford, 2012)
Timepoint [3] 300486 0
Pre-program and at six-months following program enrolment
Secondary outcome [1] 330075 0
Proportion of parents who experience improved well-being e.g. positive outlook: Measured by item developed specifically for current evaluation
Timepoint [1] 330075 0
Pre-program and at six months following program enrolment
Secondary outcome [2] 330230 0
Proportion of parents who experience improved well-being e.g. self-care: Measured by item developed specifically for current evaluation
Timepoint [2] 330230 0
Pre-program and at six months following program enrolment
Secondary outcome [3] 330231 0
Proportion of parents who experience improved well-being e.g. reduced stress: Measured by item developed for the Australian Temperament Project (Prior, Sanson, Smart & Oberklaid, 2000) and used in LSAC
Timepoint [3] 330231 0
Pre-program and at six-months following program enrolment
Secondary outcome [4] 330232 0
Proportion of parents who experience improved well-being e.g., coping: Measured by item developed for the Australian Temperament Project (Prior, Sanson, Smart & Oberklaid, 2000) and used in LSAC
Timepoint [4] 330232 0
Pre-program and at six-months following program enrolment

Eligibility
Key inclusion criteria
The evaluation will collect data from new all new MyTime members who enrol in the program from 2017, who are aged 18 years and over and who have caring responsibilities for a child with a disability or medical condition. Participants may include parents, carers or grandparents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Existing MyTime members, and new members under 18 years of age will be excluded from the current trial.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is anticipated that approximately 80% of new members (N=700) who join MyTime during the period 2017-2020 will choose to participate in the evaluation. The anticipated sample size is sufficient to detect small effects at a significance level set at 0.05 with a power value of 0.8 (minimum sample size required, N=199).

Data preparation: Data for the dynamic fidelity and outcomes questionnaires will be collated and screened for missing data and outliers. Prior to conducting any statistical tests, data will analysed to ensure compliance with test assumptions (e.g., normality, equality of variances).

Data analysis: Descriptive analyses of quantitative data will be conducted on a six-monthly basis to enable the continuous reporting of fidelity and outcome data for each partner agency. These analyses will summarise structural and dynamic fidelity data as well as outcome data (i.e., change scores) from the outcomes measure. Fidelity and outcome data will be reported on a six-monthly/annual basis in a brief data dashboard or infographic that summarises aggregated data. These may be made available to MyTime co-ordinators to enable the identification of elements of MyTime’s implementation that may need to be adjusted or strengthened. Data dashboards or infographics summarising progress on selected aggregate fidelity data may also be made available to MyTime facilitators. Dependent on sample size, it may also be possible to perform enhanced analyses such as comparisons of fidelity and outcome data between partner agencies or correlations between implementation fidelity and outcome data. Pearson correlations will be calculated for continuous variables and chi-square will be used with categorical data. Parametric statistics (t-test, ANOVA and Pearson correlation) will be used in analyses for normal data. If numbers are adequate, co-variates will be used where they are found to impact on outcomes. Effect sizes will be calculated with Cohen’s d. Cohen’s classification of effect size is as follows: scores of d=0.20 – 0.49 indicates a small effect, d=0.50 – 0.79 a moderate effect and d =0.80 a large effect (Cohen, 1988).

Level of significance: Level of significance will be set at p < 0.05, with no Bonferroni adjustment in order not to increase type II error (Rothman, 1990). This follows the assumption that the data are not random numbers (and hence the universal null hypothesis holds true), but rather actual observations of coherent phenomena (Rothman, 1990).

Reporting: Six-monthly reports summarising fidelity and outcome data collected across all groups will be prepared, with the specific goals of monitoring and strengthening the implementation of MyTime and in meeting DSS reporting requirements.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/01/2017
Actual
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295160 0
Government body
Name [1] 295160 0
Department of Social Services
Country [1] 295160 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Parenting Research Centre
Address
Level 5, 232 Victoria Parade
East Melbourne
Victoria, 3002
Country
Australia
Secondary sponsor category [1] 293984 0
None
Name [1] 293984 0
Address [1] 293984 0
Country [1] 293984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296509 0
Parenting Research Centre Human Research Ethics Committee
Ethics committee address [1] 296509 0
Ethics committee country [1] 296509 0
Australia
Date submitted for ethics approval [1] 296509 0
27/06/2016
Approval date [1] 296509 0
29/07/2016
Ethics approval number [1] 296509 0
App35

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

Contacts
Principal investigator
Name 71114 0
Dr Fiona May
Address 71114 0
Parenting Research Centre
5/232 Victoria Parade
East Melbourne
Victoria, 3002
Country 71114 0
Australia
Phone 71114 0
+61 3 86603537
Fax 71114 0
Email 71114 0
[email protected]
Contact person for public queries
Name 71115 0
Fiona May
Address 71115 0
Parenting Research Centre
5/232 Victoria Parade
East Melbourne
Victoria, 3002
Country 71115 0
Australia
Phone 71115 0
+61 3 86603537
Fax 71115 0
Email 71115 0
[email protected]
Contact person for scientific queries
Name 71116 0
Fiona May
Address 71116 0
Parenting Research Centre
5/232 Victoria Parade
East Melbourne
Victoria, 3002
Country 71116 0
Australia
Phone 71116 0
+61 3 86603537
Fax 71116 0
Email 71116 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.