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Trial registered on ANZCTR


Registration number
ACTRN12617000428369
Ethics application status
Approved
Date submitted
21/03/2017
Date registered
24/03/2017
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of behavioural sleep interventions to reduce infant sleep disturbances and improve parental mental health
Scientific title
Comparison of two beahvioural sleep interventions to reduce infant sleep disturbances and improve parental mental health: A cluster randomised control trial
Secondary ID [1] 290603 0
Nil known
Universal Trial Number (UTN)
U1111-1190-2087
Trial acronym
CBSI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 301085 0
Depression 301086 0
Anxiety 302542 0
Infant sleep disturbances 302601 0
Condition category
Condition code
Mental Health 300856 300856 0 0
Depression
Mental Health 300857 300857 0 0
Anxiety
Public Health 300858 300858 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the first intervention session (compulsory initial two hour session) parents (in both intervention conditions) will receive informational material, including a booklet of information about normal infant sleep patterns, sleep cycles and the potential for an infant to wake overnight several times. A flowchart on how to undertake each sleep intervention will also be provided to each participant. Benefits of an infant learning to fall asleep independently, parental dependence and learning theory will be discussed. Trainers will teach parents a step-by-step guide of how to reduce infant dependence on parental settling based on the principles of their specific intervention. Trainers will also teach parents to identify problems with implementation and compliance of the intervention. Barriers to success, such as attitudes, crying thresholds, parenting confidence, social support and parenting styles will be discussed.

The booklets and flowcharts that will be given out to parents have all been previously utilized in clinical settings. The controlled crying information has been taken from the Raising Children Network website. The Responsive intervention information has been taken from The "Paediatric Sleep Clinic" in Adelaide that specialise in delivering this intervention.

The controlled crying intervention will be delivered by a nurse who has been trained in the intervention by published experts in this field. This intervention will entail the following; parents will be asked to put their infant into bed (while still awake) and leave their infant alone and ignore any cries of protest for progressively increasing periods of time (for example, a parent will only return to their infant after waiting increasing intervals at their discretion such as 2, 4, 6, 8, 15 minutes, each night). Parents will then attend to their child quickly and quietly until leaving again for a longer period.

The responsive intervention method will be presented by an experienced and published clinical psychologist with over 10 years’ experience in delivering sleep interventions. This intervention will entail the following; parents will be asked to put their infant into bed (while still awake) instead of ignoring the infant for the allocated 2, 4, 6 minutes and leaving the room, parents will stay in the room and respond to the child as much as the parent pleases, but reduce the frequency and intensity of the interaction (at parental discretion) with them so that dependency on parental assistance is gradually reduced.

The mode of delivery for these sessions is face-to-face group sessions. The initial two hour session is compulsory and will be held in this format. The additional follow-up sessions are optional and if parents are unable to attend the face-to-face session, a phone call session will be held instead. The purpose of these two follow-up sessions/phone calls are to trouble shoot any issues that parents may behaving with the interventions, as well as complete follow up measures of our outcome variables (infant sleep, parental depression, sense of competency etc)

Adherence to the program will be assessed subjectively using a compliance scale ranging from "complied with the program 100%" to "did not comply with the program at all". To maintain adherence parents will be reminded about the importance of compliance with the program. Compliance measures will be taken at multiple time points throughout the interventions (i.e. at the beginning of the intervention, 2 weeks post, and 4 weeks post intervention). This will allow us to determine if parents are complying with the program and to follow-up with those that are not to see if they need further assistance with the program.

There will be 3 sessions per condition. The first session is a 2-hour compulsory training. The following two are dependent on parental availability, and will only be 1 hour long. These sessions will be held every two weeks over the period of a two months. Follow up phone calls will also be made at 3 and 4 months post intervention delivery.

The location of the intervention will be in a workshop room at Central Queensland University at the Appleton Institute, in Adelaide, South Australia.
Intervention code [1] 296465 0
Behaviour
Intervention code [2] 296466 0
Treatment: Other
Comparator / control treatment
The control group of parents will attend their first compulsory session (only 1 hour long, at the Appleton Institute) to receive informational material, including a booklet of information about normal infant sleep patterns, sleep cycles and the potential for an infant to wake overnight several times, as well as be guided on how to complete the questionnaires. They will not need to attend the venue for any further sessions. They will not receive information on any specific sleep intervention, thus, no treatment will be given. The control group will be a 'wait-list' control group' meaning they can receive the intervention of their choice at the end of the study (four months after the start of the intervention) to ensure they do not miss out on the benefit and are not disadvantaged by not receiving the intervention.
Control group
Active

Outcomes
Primary outcome [1] 301519 0
Number of infant night wakings assessed using the Actiwatch (worn for 4 cosecutive days) and parental subjective reporting of sleep/wake behaviour for their infant.

This will be a composite primary outcome.
Timepoint [1] 301519 0
These outcomes will be evident at 2 and 4 weeks post-intervention commencement.
Primary outcome [2] 301520 0
Levels of parental depression assessed by the Edinburgh Post Natal Depression scale with scores less than 10 indicating adequate mental health functioning.
Timepoint [2] 301520 0
This will be evident at baseline, 2 and 4 weeks post-intervention commencement.
Primary outcome [3] 301557 0
Parenting sense of competency as assessed by the Parenting Sense of Competency scale. This will be a subjective scale in which higher scores indicate higher levels of competency with the parents' abilities to put their child to sleep successfully.
Timepoint [3] 301557 0
This will be evident at baseline, 2 and 4 weeks post-intervention commencement
Secondary outcome [1] 332914 0
Our first secondary outcome is determining the difference between groups in levels of compliance with the intervention groups. This will be assessed using a self-report compliance scale ranging from "complied with the program 100%" to "did not comply with the program at all".
Timepoint [1] 332914 0
This will be evident after baseline, 2 and 4 weeks after commencement of the interventions.
Secondary outcome [2] 332915 0
Levels of stress in different sleep interventions on the infant and parent. This will be assessed using the Subjective Stress Scale (SUDS) for the parent, and salivary collection from the infant to determine levels of cortisol (stress hormone) in the child at the time of the intervention
Timepoint [2] 332915 0
The time point for this outcome will be after the first attempt of the sleep intervention following the first intervention session (at baseline). Samples will be assayed and analysed, and then compared to the subjective scale.
Secondary outcome [3] 333020 0
Levels of attrition- this will be assessed based on how many parents withdraw from the study, and more specifically from each intervention.
Timepoint [3] 333020 0
This will be determined by 2, 4, and 8 weeks after commencement of the intervention.
Secondary outcome [4] 333021 0
Levels of attachment between the parent and their infant. This outcome will be measured using the Parental Attachment Questionnaire (PAQ)
Timepoint [4] 333021 0
This outcome will be evident at baseline 2 and 4 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Key inclusion criteria is as follows:
Participant is a parent or guardian of an infant aged 4-12 months of age
Participant resides in South Australia
Participant is seeking help with their infants sleep
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infant born pre-term (less than 37 weeks gestation)
Infant is a twin not a singleton
Infant has been diagnosed with a physiological sleep disorder
Infant has been diagnosed with a syndrome or health issue that compromises sleep

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Methods:
A sample of 50 participants is needed to match that of previous research in this field (Gradisar et al., 2016).

Statistical Analysis:
Quantitative data will be collected over four months across the conditions in two waves. The primary outcome variables are infant sleep disturbance (measured by the Actiwatch), infant stress (cortisol), and parental stress (cortisol and SUDS scale). Secondary variables include parental mood (depression), parental competency scores, parent-child attachment, and compliance and attrition rates.
Aim One: A linear mixed effects model will be run to determine differences in infant sleep disturbance (measured objectively by the Actiwatch) between groups (controlled crying, responsive and control group) across the time points (T0, T1, T2, T3, T4).

Aim Two: A Multivariate Analysis of Variance (MANOVA) will be run to determine group differences in parental depression and levels of competence, as well as determine the relationship between these factors.

Aim Three: A linear mixed effects model will be run to determine group differences between the interventions (controlled crying, responsive and control group) at the five time points in relation to the two secondary variables of interest; compliance and attrition, as well as explore the relationship between these two variables. This analysis will be followed up by a qualitative analysis using Nvivo to determine reasons for attrition.

Aim Four: A linear mixed effects model will be run to explore group differences in levels of stress (measured objectively by cortisol) between conditions (controlled crying, responsive and control group) at different cortisol collection time points (four samples a night after 6pm) on different days (Day 1 & Day 2 of baseline measure).

Qualitative data analyses:
To further achieve the third aim of understanding compliance and attrition, all parents who withdrew from the study will be immediately invited to participate in a short five minute telephone interview to gain accounts of their reason for discontinuing the interventionThey will also be mailed out follow-up qualitative questionnaires at the same times as other participants (eight and 16 weeks) to determine if they have since sought advice, implemented or trialled either or both interventions, or experienced spontaneous improvement of their infant’s sleep. At the conclusion of the whole study, all parents (including those who withdrew from the study) will also complete an exit survey which will include open ended questions such as “Which aspects of the intervention were most helpful for you?” All interviews will be recorded, transcribed and analysed with the aid of NVivo (version 10, developed by QSR), a software tool for organising, searching, and coding qualitative data. Thematic and content analyses will be undertaken to get both an interpretation of the meanings of participant responses, and gather information on the reoccurring responses.

Controlling for Covariates:
Running linear mixed effects models allows us to control for confounding variables that include age, health status, infant temperament and mother-infant attachment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/03/2017
Date of last participant enrolment
Anticipated
21/12/2018
Actual
Date of last data collection
Anticipated
29/03/2019
Actual
Sample size
Target
50
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 15619 0
5034 - Goodwood

Funding & Sponsors
Funding source category [1] 295987 0
University
Name [1] 295987 0
Central Queensland University
Country [1] 295987 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
44 Greenhill Road, Wayville, 5034, SA
Country
Australia
Secondary sponsor category [1] 294874 0
None
Name [1] 294874 0
N/A
Address [1] 294874 0
N/A
Country [1] 294874 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297249 0
CQUniversity's Human Research Ethics Committee
Ethics committee address [1] 297249 0
CQUniversity Australia, Building 32, Bruce Highway
Rockhampton, Queensland 4702
Ethics committee country [1] 297249 0
Australia
Date submitted for ethics approval [1] 297249 0
22/11/2016
Approval date [1] 297249 0
17/02/2017
Ethics approval number [1] 297249 0
H16/11-309

Summary
Brief summary
The cumulative impact of infant sleep and settling problems is consequential for both the infant and their parents. Options to improve infant sleep disturbance most commonly include behavioural sleep interventions. A large amount of research has focused on extinction based sleep interventions (controlled crying) that are typically centred on ignoring an unwanted behaviour (night time crying) to allow the infant to settle on their own. However, majority of parents find controlled crying unpalatable. Recently, there has been an increased focus on finding alternatives that focus on responding to infant cries rather than ignoring them (cue-based or responsive methods). These methods have not been directly and empirically tested against controlled crying are not systematically available.

The aims of this study are to investigate the differences between two forms of infant sleep interventions (controlled crying and responsive methods) compared to a control group, on infant sleep disturbance and parental and infant well-being. These aims will be achieved by providing parents with education on infant sleep based on which intervention group they have been assigned to. After these sessions, parents will undertake this intervention in their own home and complete the outcome measures to determine the success of each intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70682 0
Miss Yaroslava King
Address 70682 0
Appleton Institute for Behavioural Science
CQUniversity Australia, Adelaide Campus
44 Greenhill Road, Wayville, 5034, SA
Country 70682 0
Australia
Phone 70682 0
+61424616003
Fax 70682 0
Email 70682 0
[email protected]
Contact person for public queries
Name 70683 0
Yaroslava King
Address 70683 0
Appleton Institute for Behavioural Science
CQUniversity Australia, Adelaide Campus
44 Greenhill Road, Wayville, 5034, SA
Country 70683 0
Australia
Phone 70683 0
+61424616003
Fax 70683 0
Email 70683 0
[email protected]
Contact person for scientific queries
Name 70684 0
Sarah Blunden
Address 70684 0
Appleton Institute for Behavioural Science
CQUniversity Australia, Adelaide Campus
44 Greenhill Road, Wayville, 5034, SA
Country 70684 0
Australia
Phone 70684 0
+61414700953
Fax 70684 0
Email 70684 0
[email protected]

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No Supporting Document Provided



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