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Trial registered on ANZCTR


Registration number
ACTRN12613001098729
Ethics application status
Approved
Date submitted
20/09/2013
Date registered
1/10/2013
Date last updated
1/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cry Baby: evaluation of an online program for parents.
Scientific title
Evaluation of the online Cry Baby program: a universal online program that aims to increase parent understanding of normal infant sleeping and crying patterns and reduce associated parental depression and fatigue.
Secondary ID [1] 283255 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental behaviours 290161 0
Infant sleep 290162 0
Infant crying 290163 0
Depression 290164 0
Fatigue 290165 0
Condition category
Condition code
Mental Health 290512 290512 0 0
Depression
Mental Health 290513 290513 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Cry Baby" presents previously tested advice and strategies in an interactive and informative online program. The program will be offered to parents for a period of 3 months. It provides parents with information and strategies on how to cope with infant crying, strategies to improve infant sleep, and advice on avoiding the Sudden Infant Death Syndrome (SIDS) risk associated with co-sleeping and placing their baby to sleep other than on his/her back.

The Cry Baby program covers the following content:
a. Parent self care: including information and strategies on taking care of your body, parent sleep, wellbeing, postnatal depression and advice while breast feeding.
b. Crying: Why crying is normal and healthy, the normal crying curve, why babies cry, and how to cope with crying.
c. Sleeping: Information and advice on how infants learn to sleep, their sleep cycles and cues, how to settle babies, safe sleep conditions, feeding, wrapping and dummies.

Parents will be allocated to one of two conditions:
a. Cry Baby only condition: participants allocated to this condition will receive log in details to complete the Cry Baby program online, at a time that suits them best. The program only takes an hour to complete but parents can log in or out of the program whenever they please and can move around different areas of the program according to their interests and needs.
b. The Cry Baby with additional email prompts condition: Participants who are randomly allocated to this condition will receive the Cry Baby program (which takes an hour to complete; ability to log in and out as please) but will also receive weekly, age specific email prompts from the study team until their infant reaches 12 weeks of age. These messages will contain brief age appropriate information on infant sleep and crying that is already provided within the Cry Baby program, and will direct the parent back to the program for more detailed information. Parents allocated to this condition will potentially receive a maximum of 12 emails. Participants are free to withdraw from receiving email contact from the study team at any time and this is made clear in the participant information sheet and weekly additional prompt emails.
Intervention code [1] 287986 0
Behaviour
Comparator / control treatment
Cry Baby only condition, without additional email prompts.
Control group
Active

Outcomes
Primary outcome [1] 290534 0
Program uptake (i.e., number of parents recruited assessed by online monitoring of resource).
Timepoint [1] 290534 0
T1: Baseline (recruitment)
T2: Follow-up (infant aged 16 weeks)
Primary outcome [2] 290535 0
Parent engagement with the resources (i.e., online monitoring of when participants access the resource and what they access, open ended questions of follow-up questionnaire regarding how useful they find it ).
Timepoint [2] 290535 0
T2: Follow-up (infants aged 16 weeks)
Primary outcome [3] 290536 0
Program completion rate (i.e., number of participants who complete the baseline survey, view the online resource and complete the follow-up survey).
Timepoint [3] 290536 0
T2: Follow-up (infants aged 16 weeks)
Secondary outcome [1] 304750 0
Parent mental health symptoms including depression (Edinburgh Postnatal Depression Scale) and fatigue (Fatigue Assessment Scale; Fatigue Severity Scale).
Timepoint [1] 304750 0
T1: Baseline (recruitment)
T2: Follow-up (infants aged 16 weeks)

Eligibility
Key inclusion criteria
(a) Over 18 years of age.
(b) Have a new born infant less than 12 weeks of age at recruitment.
(c) Have a new born infant born at 33 weeks (or more) gestation.
(d) Parent and infant free from serious medical conditions that require high level medical care.
(e) Sufficient English literacy for completion of study materials.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) Under 18 years of age.
(b) Have an infant over 12 weeks of age.
(c) Have an infant born less than 33 weeks gestation.
(d) Parent and/or infant have a serious medical condition.
(e) Insufficient English for completion of study materials.

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)
Parents are recruited via one of the two following methods (a) Maternal and Child Health, and (b) Raising Children Network. Participants self-enrol into the program by completing the online eligibility criteria and baseline survey. At the end of the baseline survey, participants are allocated to one of the two conditions through a secure computer-generated randomisation system, maintaining allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online survey provider (Survey Monkey) has a 'random assignment' option where a percentage of respondents can be specified to be allocated to one of the conditions. As there are two conditions within Cry Baby, Survey Monkey was specified to split allocation by 50%, thus giving every participant an equal (or 50/50) chance of being allocated to one of the two study conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287995 0
Government body
Name [1] 287995 0
Victorian Government Department of Education and Early Childhood Development
Address [1] 287995 0
Office for Children and Early Childhood Development

35 Spring Street,
Melbourne,
3001, Victoria.
Country [1] 287995 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Parenting Research Centre
Address
Level 5 / 232 Victoria Parade,
East Melbourne,
3002, Victoria.
Country
Australia
Secondary sponsor category [1] 286714 0
Other Collaborative groups
Name [1] 286714 0
Murdoch Childrens Research Institute
Address [1] 286714 0
Royal Children's Hospital
Flemington Road,
Parkville,
3052, Victoria.
Country [1] 286714 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289920 0
Parenting Research Centre Human Research Ethics Committee
Ethics committee address [1] 289920 0
Level 5, 232 Victoria Parade,
East Melbourne,
3002, Victoria.
Ethics committee country [1] 289920 0
Australia
Date submitted for ethics approval [1] 289920 0
Approval date [1] 289920 0
17/12/2012
Ethics approval number [1] 289920 0
App18

Summary
Brief summary
During the first few months of life, parent reported infant sleep and crying problems are common (20-40% and 20% of infants, respectively; Bayer et al, 2007; Wake et al, 2007), as well as costly to treat (Hiscock et al 2007). Six randomised controlled trials have shown that providing parents with information on normal infant sleep and crying, and strategies to encourage good sleep habits, can improve infant sleep as well as reduce maternal postnatal depression symptoms (Hiscock et al , in preparation). While there is evidence that such strategies are of significant benefit to families and are well accepted by families, dissemination of this information to all families with newborns will be challenging. Our research team, in consultation with other health care professionals, has developed Cry Baby – an interactive online program that draws on prior research findings to provide parents with evidence based strategies for how to cope with infant sleep and crying problems.

The aim of this research is to: (1) trail two different recruitment processes for providing the Cry Baby program in order to determine the best way to ensure it effectively reaches the families who would benefit; (2) collect data on how families engage with the resource (i.e., when they access it, what they access, how useful they find it) to better refine the program; (3) collect data on whether email support increases program participation, and; (4) collect preliminary data on outcome measures.

Parents will be recruited from two settings: (1) the Maternal and Child Health (MCH) service at the 2 week visit, and; (2) through advertisements on the Raising Children Network (RCN) website. Parents will be randomly assigned to either receive the Cry Baby program with email support from the research team, or to receive the Cry Baby program without additional email support. Data collected from this pilot study will indicate: (1) whether recruitment via online advertising (RCN) or via known health professional (MCH) result in a sample of participants more reflective of the general community (household income, education, socioeconomic status, language); (2) whether providing weekly email support results in parents (a) logging in to the program more often, (b) completing a greater proportion of the program, and (c) increased retention to the program; and (3) whether parents find the program useful/helpful.
Trial website
http://raisingchildren.net.au/articles/cry_baby_online_research_project.html/context/255
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43098 0
Dr Fallon Cook
Address 43098 0
Parenting Research Centre,
5/232 Victoria Parade,
East Melbourne,
3002, Victoria
Country 43098 0
Australia
Phone 43098 0
+61 3 8660 3508
Fax 43098 0
Email 43098 0
fcook@parentingrc.org.au
Contact person for public queries
Name 43099 0
Dr Fallon Cook
Address 43099 0
Parenting Research Centre,
5/232 Victoria Parade,
East Melbourne,
3002, Victoria
Country 43099 0
Australia
Phone 43099 0
+61 3 8660 3508
Fax 43099 0
Email 43099 0
fcook@parentingrc.org.au
Contact person for scientific queries
Name 43100 0
Dr Fallon Cook
Address 43100 0
Parenting Research Centre,
5/232 Victoria Parade,
East Melbourne,
3002, Victoria
Country 43100 0
Australia
Phone 43100 0
+61 3 8660 3508
Fax 43100 0
Email 43100 0
fcook@parentingrc.org.au

No data has been provided for results reporting
Summary results
Not applicable