Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001114831
Ethics application status
Approved
Date submitted
28/06/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The wellbeing of parents of children with and without developmental disabilities in Aotearoa New Zealand
Scientific title
The mental health and wellbeing of parents of children with and without developmental disabilities in Aotearoa New Zealand
Secondary ID [1] 304602 0
None
Universal Trial Number (UTN)
Trial acronym
U1111-1267-0617
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 322511 0
Well-being 322512 0
Condition category
Condition code
Mental Health 320147 320147 0 0
Depression
Mental Health 320148 320148 0 0
Anxiety
Mental Health 320149 320149 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants will complete each phase of the study using the measures outlined below which assess parental stress and wellbeing:

Initial caregiver survey (Phase I): Questions will gather basic demographic information, such as family make-up (how many children with and without disabilities, types of disabilities, age of children, number of adults in the home, location, etc.), ethnicity, etc. The survey will take no more than 20 minutes to complete. Parents will also be asked to complete an online version of the Strengths and Difficulties Questionnaire (Goodman et al., 2010); a 25-item assessment children’s emotional regulation, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behaviour, and the Social Communication Questionnaire (Rutter et al., 2003).

Following completion of the initial survey (Phase I), all participants will be asked to begin Phase II which includes collecting daily data on the ExpiWell app and completing the bi-weekly mood and parenting survey (bi-weekly) for 7 weeks. Phase II is outlined below:

Ecological Momentary Assessment Protocol (Phase II): This protocol will be administered bi-weekly, starting Week 1 (e.g. Weeks 1, 3, 5, 7), consisting of a series of very brief (<5 minute) daily EMA surveys 4x/day for 7 days. EMA data will be collected via ExpiWell, an app developed by US researcher Dr. Louis Tay. CEO of ExpiWell (Dr Torres) is an advisor on this project. Families download Expiwell to their personal smartphones, and all data are maintained centrally by our research team. Assessments will be randomly sampled between 7-10AM, 11-2PM, 2-5PM, and 6-9PM. If needed, adjustments can be made based on participant schedules. EMA Surveys include items related to sleep, alcohol use, nutrition, daily activities, stress, coping strategies, exercise, caregiving responsibility, and child problem behaviours. Items were selected from previously published EMA studies and adapted to the current study. Each survey will include fewer than 25 multiple-choice questions to minimize respondent burden.

During Phase II parents will also complete a Mood and Parenting Survey. This protocol will be administered biweekly, starting Week 1 (e.g. Weeks 1, 3, 5, 7) to coincide with collection of EMA data. Families will be administered a semi-brief (<15 minutes) biweekly survey once during the same week as EMA data collection, to assess overall mood and sense of parenting competence. This will include validated measures of depression, anxiety and stress (Depression, Anxiety, and Stress Scale; 21 items), parenting competency (Parenting Sense of Competency Scale; 17 items), and social support (Duke Social Support and Stress Scale; 24 items). This data will be collected via an online survey administered using Qualtrics.

The overall duration of the observation period is 7 weeks, post-enrolment.

All study components can be completed at home. Participants can use a phone or personal computer to complete assessments.

Participants are notified about each assessment with a push notification to their smart phone with an unobtrusive message (i.e. "Time to fill out a survey"). These notifications will be provided each time the EMA survey is available (i.e., four times/day). A second notification will be sent for each survey, 45 minutes after the first notification, if participants have not completed the survey. Participants will have one hour from the first notification to respond to the relevant survey. If parents do not complete any surveys over two consecutive days, they will be contacted by a member of the research team via email.
Intervention code [1] 320951 0
Not applicable
Comparator / control treatment
Parents of children with no diagnosed developmental disorder
Control group
Active

Outcomes
Primary outcome [1] 328023 0
Mean score on Depression, Anxiety and Stress Scale
Timepoint [1] 328023 0
Once during week 1, 3, 5, and 7 post-enrolment, using the bi-weekly parenting and mood survey.
Primary outcome [2] 328025 0
Mean scores on Parenting Sense of Competency Scale
Timepoint [2] 328025 0
Once during week 1, 3, 5, and 7 post-enrolment, using the bi-weekly parenting and mood survey.
Primary outcome [3] 328026 0
Mean scores on Duke Social Support and Stress Scale
Timepoint [3] 328026 0
Once during week 1, 3, 5, and 7 post-enrolment, using the bi-weekly parenting and mood survey.
Secondary outcome [1] 397265 0
Primary outcome - Total sleep duration each night

Assessed by entering hours and minutes slept, and rating on a 0-100 scale of perceived quality of sleep.
Timepoint [1] 397265 0
Once per day for seven days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment
Secondary outcome [2] 398406 0
Primary outcome - the amount and type of alcohol consumed each day

Assessed by two multiple-choice responses (e.g. what type of alcohol consumed, how many mLs of this alcohol).
Timepoint [2] 398406 0
Once per day for seven days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment
Secondary outcome [3] 398407 0
Primary outcome - the number of cigarettes (or e-cigarettes) smoked each day

Assessed by entering the number cigarettes (or e-cigarettes) were smoked.
Timepoint [3] 398407 0
Once per day for seven days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment
Secondary outcome [4] 398408 0
Composite Primary outcome - the amount of physical activity (i.e., leisurely walk, wading in ocean) done the previous day.

Assessed by entering total amount of time (in minutes) participants did this type of exercise the previous day.
Timepoint [4] 398408 0
Once per day for seven days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment
Secondary outcome [5] 398409 0
Primary outcome - the type of food eaten during each meal (i.e., breakfast, lunch, dinner).

Assessed by asking what meal was last consumed, and a multiple-choice option specifying what type of food they consumed (i.e., fast food, pre-prepared/purchased food, or homemade/freshly prepared food consumed).
Timepoint [5] 398409 0
Three times per day for 7 days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment
Secondary outcome [6] 398411 0
Primary outcome - Parent rating of level of stress they are experiencing.

Levels of stress assessed on a sliding scale from 0-100.

Timepoint [6] 398411 0
During each of the four daily EMA surveys for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [7] 398414 0
Primary outcome - Feelings that participants are experiencing at the time of the survey (e.g. upset, hostile, alert, ashamed, inspired, nervous etc.).

Assessed by rating 0-100 on a sliding scale
Timepoint [7] 398414 0
During each of the four daily EMA surveys for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [8] 398415 0
Primary outcome - Strategies used to manage any negative feelings or stress participants may be experiencing

Assessment by selecting from a list of options or entering text in the 'other' open text box.
Timepoint [8] 398415 0
During each of the four daily EMA surveys for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [9] 398416 0
Primary outcome - How much time participants spend doing daily activities (e.g. parenting, paid work, chores, leisure etc.)

Selecting the amount of time from the available options (none, less than 1 hour, 1-2 hours, 3-4 hours, 5-6 hours, 7 or more hours) for each category
Timepoint [9] 398416 0
Once per day during the final daily survey within the EMA surveys, for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [10] 398417 0
Primary outcome - How much caregiving responsibility did participants have today.

Assessment using a sliding scale indicating little to none to full responsibility.
Timepoint [10] 398417 0
Once per day during the final daily survey within the EMA surveys, for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [11] 398419 0
Composite primary outcome - How many problem behaviours did children exhibit each day.

Assessed by selecting from a list of options (i..e., no problem behaviours, few, some, many, extremely high).
Timepoint [11] 398419 0
Once per day during the final daily survey within the EMA surveys, for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [12] 398423 0
Primary outcome - perceived levels of support with caregiving responsibilities.

Assessed using a sliding scale from 0-100 scale
Timepoint [12] 398423 0
Once per day during the final daily survey within the EMA surveys, for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [13] 398426 0
Primary outcome - What forms of social support participants receive each day.

Assessment by selecting from a list of options (e.g. in person, phone call, texts, skype, social media, none received).
Timepoint [13] 398426 0
Once per day during the final daily survey within the EMA surveys, for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [14] 398427 0
Secondary outcome - In what ways COVID-19 has caused participants stress.

Assessment by selecting from a list of options (changes to family routine, finances, health, social support, education) or selecting none.
Timepoint [14] 398427 0
Once per day during the final daily survey within the EMA surveys, for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [15] 398478 0
The impact of COVID-19 on caregivers if alert levels change.

Assessed by repeating the EMA survey procedures outlined in the outcome boxes above.
Timepoint [15] 398478 0
If COVID-19 alert levels change the procedures and measures outlined above will be repeated daily, every second week, for 7 weeks for participants who provide consent.
Secondary outcome [16] 399576 0
Primary outcome - What was the intensity of problem behaviours children exhibited today.

Assessed by selecting from a list of options (i..e., not intense, somewhat intense, very intense).
Timepoint [16] 399576 0
Once per day during the final daily survey within the EMA surveys, for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [17] 399577 0
Primary outcome - Parent reported source of stress

Assessed by indicating what sources of stress they are experiencing from a list of options or entering text as indicated in the 'other' open text box.
Timepoint [17] 399577 0
During each of the four daily EMA surveys for 7 days, during weeks 1, 3, 5, and 7 post-enrolment.
Secondary outcome [18] 399578 0
Primary outcome - the amount of meditation activity (i.e., yoga, mindfulness) done the previous day.

Assessed by entering total minutes/hours participants did this type of exercise the previous day.
Timepoint [18] 399578 0
Once per day for seven days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment
Secondary outcome [19] 399579 0
Primary outcome - the amount of strength training activity (i.e., weight machines, rock climbing) done the previous day

Assessed by entering total minutes/hours participants did this type of exercise the previous day.
Timepoint [19] 399579 0
Once per day for seven days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment
Secondary outcome [20] 399580 0
Primary outcome - the amount of vigorous aerobic activity (i.e., running, rapid dancing, biking) done the previous day

Assessed by entering total minutes/hours participants did this type of exercise the previous day.
Timepoint [20] 399580 0
Once per day for seven days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment
Secondary outcome [21] 399581 0
Primary outcome - the amount of moderate aerobic activity (i.e., brisk walk, swimming, mowing lawn) done the previous day

Assessed by entering total minutes/hours participants did this type of exercise the previous day.
Timepoint [21] 399581 0
Once per day for seven days, during weeks 1, 3, 5 and 7, using the EMA survey post-enrolment

Eligibility
Key inclusion criteria
(1) caregiver of a child 18 years of age or under
(2) access to iOS/Android phone with wifi or data connection
(3) reside in New Zealand
(4) primary language spoken in the home is English.

Additional inclusion criteria will apply to sub-groups:
(1) We aim for 25/75 participants to be caregivers of a child with a formal diagnosis of autism spectrum disorder, provided by an appropriate healthcare professional (e.g., developmental paediatrician)
(2) 25/75 participants will be caregivers of a child with a Rare Genetic Neurodevelopmental Disorder (RGND), determined by a medical professional (e.g., developmental paediatrician). For the purpose of this study, RGND are defined as a group of syndromes
characterized by an abnormal structure and number of chromosomes [Davis et al., 2018]. A disorder is considered ‘rare’ if it affects <1/2,000 of the general population [European Commission, 2018].
(3) 25/75 participants will be caregivers of a child without a known developmental disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive analysis of baseline demographic and SDQ data will be done to obtain median, means, standard deviations, and range for the whole sample, and each subsample.

Analysis of EMA data will be done by plotting trajectories for each case and examining these for any similarities or differences. Based on these results, the EMA data will be aggregated to give means for each case, and these means will be used in further analyses. The same method will be used to analyse the psychometric data, plotting trajectories so we can look for any fluctuations that occur over time. Depending on this, a single score will then be calculated for each psychometric test and used in further analyses.

A large correlation matrix will be used to look at relationships between all of the dependent variables, including demographic factors and children’s SDQ scores. Based on the results of the correlations, regression analyses will be used find what factors best predict, or moderate parental outcomes. These analyses will include:

1. Prediction of variation in mental health and wellbeing by social and economic (demographic) characteristics

2. Prediction of variation in daily health behaviours by social and economic (demographic) characteristics.

3. Prediction of variation in Stress levels, mental health, well-being, and family life by child's developmental disability status.

4. Prediction of variation in Daily health behaviours including sleep, exercise, alcohol use and nutrition by child's developmental disability status.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/07/2021
Date of last participant enrolment
Anticipated
27/06/2022
Actual
Date of last data collection
Anticipated
29/08/2022
Actual
Sample size
Target
75
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 23837 0
New Zealand
State/province [1] 23837 0

Funding & Sponsors
Funding source category [1] 308965 0
University
Name [1] 308965 0
University of Canterbury
Country [1] 308965 0
New Zealand
Primary sponsor type
Individual
Name
A/Prof. Laurie McLay
Address
School of Health Sciences - University of Canterbury
Private bag 4800
Christchurch 8041
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309898 0
University
Name [1] 309898 0
University of Canterbury
Address [1] 309898 0
University of Canterbury
20 Kirkwood Avenue,
Upper Riccarton,
Christchurch 8041
New Zealand
Country [1] 309898 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308853 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308853 0
Ethics committee country [1] 308853 0
New Zealand
Date submitted for ethics approval [1] 308853 0
19/02/2021
Approval date [1] 308853 0
16/03/2021
Ethics approval number [1] 308853 0
21/NTB/53

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

Contacts
Principal investigator
Name 112122 0
A/Prof Laurie McLay
Address 112122 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch
8140
Country 112122 0
New Zealand
Phone 112122 0
+64 03 3693522
Fax 112122 0
Email 112122 0
[email protected]
Contact person for public queries
Name 112123 0
Laurie McLay
Address 112123 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch
8140
Country 112123 0
New Zealand
Phone 112123 0
+64 03 3693522
Fax 112123 0
Email 112123 0
[email protected]
Contact person for scientific queries
Name 112124 0
Laurie McLay
Address 112124 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch
8140
Country 112124 0
New Zealand
Phone 112124 0
+64 03 3693522
Fax 112124 0
Email 112124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will not be sharing individual participant data as this has not been approved by our ethics committee.


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.