Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000133932
Ethics application status
Approved
Date submitted
31/01/2011
Date registered
4/02/2011
Date last updated
4/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of 'Wide Awake Parenting': A program for the management of parental fatigue.
Scientific title
An effectiveness trial of 'Wide Awake Parenting': A program for the management of parental fatigue and parental behaviours in parents of infants aged 0-6 months.
Secondary ID [1] 253203 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue 258737 0
Parental Behaviours 261062 0
Condition category
Condition code
Mental Health 258888 258888 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 259201 259201 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Wide Awake Parenting" (WAP) is a psycho-educational intervention offering:
1. Psyho-education about fatigue, the experience and symptoms of fatigue, the relationship of fatigue to mental health and well-being during early parenting, and the effect of fatigue on parenting behaviours and practices.

2. Behavioural strategies aimed to improve symptoms of fatigue, parenting competence and parent mood and well-being, including:
a. support for improved parental self-care, including information on sleep hygeine, rest, health eating and acitivity. b. negotiating practical and emotional support
c. challenging unhelpful thinking
d. managing priorities and expectations
e. negotiating discretionary leisure time
f. problem-solving
g. planning and evaluation of strategies tailored to each parents'needs; tips to sustain this beyond the life of the intervention
WAP is a written resource, and includes information, tips, strategies and acitivities for parents to complete. The trial will evaluate two modes of WAP delivery:

a. Profesionally led by clinical psychologists: Includes an initial one hour home visit; three telephone-support follow-up sessions, of approximately 20 mins duration, one per week for three weeks, for a total duration of one month.

b. Parent self-directed: parents will be given the WAP workbook with instructions to complete one of four 'sessions' of information and activities per week, for a total of one month duration, but will have no further contact with research team about the WAP materials.
Intervention code [1] 257682 0
Behaviour
Intervention code [2] 257939 0
Lifestyle
Comparator / control treatment
Parents randomised to the control arm of the study will not receive any of the WAP materials. They will have standard community-based care received by all parents in the postnatal period.
Following the completion of data collection, parents in the control arm of the study will be offered the option of receiving the WAP intervention (with or without professional support).
Control group
Active

Outcomes
Primary outcome [1] 259745 0
Reduced parental fatigue and improved well-being, assessed using the following standardised measures:

1. Fatigue Assessment Scale (Michielsen et al., 2004)
2. Profile of Mood States (McNair et al., 1971)
3. Depression, Anxiety and Stress Scale (Lovibond et al., 1995)
Timepoint [1] 259745 0
T1: Baseline (recruitment)
T2: Post test (2 weeks following intervention)
T3: Follow-up (2 months following intervention)
Secondary outcome [1] 266493 0
Improved parent-child interactions, assessed using standardised measures including:
1. Higher parenting self-efficacy (Parenting Sense of Competence Scale, Jonhston et al., 1989)
2. More warmth, less hostility (Scales adapted from Longitudinal Study of Australian Children, Sanson et al., 2002)
3. Lower parenting stress (Parenting Stress Index, Abidin, 1986)
Timepoint [1] 266493 0
T2: Post-test
T3: Follow-up (2 months post intervention)

Eligibility
Key inclusion criteria
Over 18 years of age
Sufficient English literacy for completion study materials
Parent of an infant aged <4 months at recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age
Parents of an infant < 4 months of age
Insufficient English for completion of study materials

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitement:
All eligible parents will be provided information during routine maternal and child health nurse visits in participating Local Government Areas. Parents who express interest in the study and agree to be contacted by the Research Team will be provided further written and verbal information about the study. Signed consent will be secured from those parents who agree to study participation.

Randomisation:
The random allocation sequence will be generated before the recruitment period begins. Participants will be allocated to either one of the two intervention groups, or the control group following completion of baseline data. Randomisation will be performed at the individual or family level using a simple randomisation method. Senior team researchers will set up the randomisation system but will not be involved in the allocation of participants. Allocation concealment will be conducted to shield the project staff responsible for registering parents into the trial from knowing upcoming assignments, sequentially numbered, opaque, sealed envelopes will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A true random number sequence will be acquired from the service provided by www.random.org.
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
221
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258407 0
Government body
Name [1] 258407 0
Victorian Government Dept. of Education and Early Childhood Development
Country [1] 258407 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Parenting Research Centre
Address
Level 5 / 232 Victoria Parade
East Melbourne
VIC 3002
Country
Australia
Secondary sponsor category [1] 257557 0
None
Name [1] 257557 0
Address [1] 257557 0
Country [1] 257557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260379 0
Parenting Research Centre Human Research Ethics Committee
Ethics committee address [1] 260379 0
Ethics committee country [1] 260379 0
Australia
Date submitted for ethics approval [1] 260379 0
Approval date [1] 260379 0
17/11/2010
Ethics approval number [1] 260379 0
App06; 2010

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

Contacts
Principal investigator
Name 31967 0
Address 31967 0
Country 31967 0
Phone 31967 0
Fax 31967 0
Email 31967 0
Contact person for public queries
Name 15214 0
Dr Rebecca Giallo
Address 15214 0
C/-Parenting Research Centre
Level 5
232 Victoria Parade
East Melbourne
Victoria 3002
Country 15214 0
Australia
Phone 15214 0
+61 3 8660 3500
Fax 15214 0
Email 15214 0
[email protected]
Contact person for scientific queries
Name 6142 0
Dr Rebecca Giallo
Address 6142 0
C/-Parenting Research Centre
Level 5
232 Victoria Parade
East Melbourne
Victoria 3002
Country 6142 0
Australia
Phone 6142 0
+61 3 8660 3500
Fax 6142 0
Email 6142 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
SourceTitleYear of PublicationDOI
Dimensions AIWide Awake Parenting: study protocol for a randomised controlled trial of a parenting program for the management of post-partum fatigue2013https://doi.org/10.1186/1471-2458-13-26
N.B. These documents automatically identified may not have been verified by the study sponsor.