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Trial registered on ANZCTR


Registration number
ACTRN12606000263594
Ethics application status
Approved
Date submitted
26/06/2006
Date registered
28/06/2006
Date last updated
18/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Toward Parenthood Program
Scientific title
Toward Parenthood: delivering an antenatal self-help intervention with telephone support for depression, anxiety and parenting difficulties - facilitating the perinatal health journey.
Universal Trial Number (UTN)
Trial acronym
TPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal depression 1239 0
Anxiety 1240 0
Parenting difficulties 1241 0
Condition category
Condition code
Reproductive Health and Childbirth 1324 1324 0 0
Antenatal care
Mental Health 1325 1325 0 0
Depression
Mental Health 1326 1326 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ntervention group receives self-help guidebooks (for participants and their partners), 8 weekly telephone support sessions from therapists until 6 weeks postpartum and networking with health professionals.
Intervention code [1] 1166 0
Prevention
Comparator / control treatment
Control group receive routine primary care as usual and networking with health professionals.
Control group
Active

Outcomes
Primary outcome [1] 1810 0
Beck Depression Inventory - Second Edition.
Primary and secondary outcomes will be analysed by intention-to-treat.
Timepoint [1] 1810 0
At entry to trial (20-32 weeks of pregnancy) and 12 weeks postpartum
Primary outcome [2] 1811 0
Anxiety subscale of the Depression Anxiety Stress Scales.
Primary and secondary outcomes will be analysed by intention-to-treat.
Timepoint [2] 1811 0
At entry to trial and 12 weeks postpartum
Primary outcome [3] 1812 0
Parenting Stress Index (participants and their partners).
Primary and secondary outcomes will be analysed by intention-to-treat.
Timepoint [3] 1812 0
At 12 weeks postpartum
Secondary outcome [1] 3177 0
Depression Anxiety Stress Scales
Timepoint [1] 3177 0
At entry to trial and 12 weeks postpartum for partners.
Secondary outcome [2] 3178 0
Information about birth & services used
Timepoint [2] 3178 0
At 12 weeks postpartum for participants.

Eligibility
Key inclusion criteria
Participants will be women, 20-30 weeks pregnant.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to understand written English; patients without a major psychiatric disorder or extreme level of distress (as measured by the General Health Questionnaire).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised administration of a coded, double-blinded pre-generated allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable-length permuted blocks, computer generated random sequence, stratified by screening result.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1453 0
Charities/Societies/Foundations
Name [1] 1453 0
beyondblue: the national depression initiative - Victorian Centre of Excellence in Depression and Related Disorders
Country [1] 1453 0
Australia
Primary sponsor type
Other
Name
Parent-Infant Research Institute, Austin Health, Melbourne
Address
Heidelberg Repatriation Hospital
Banksia St
Heidelberg Heights VIC 3081
Country
Australia
Secondary sponsor category [1] 1282 0
Hospital
Name [1] 1282 0
The Northern Hospital, Melbourne
Address [1] 1282 0
185 Cooper St
Epping VIC 3076
Country [1] 1282 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2829 0
Eastern Health REC
Ethics committee address [1] 2829 0
Ethics committee country [1] 2829 0
Australia
Date submitted for ethics approval [1] 2829 0
Approval date [1] 2829 0
16/05/2006
Ethics approval number [1] 2829 0
E81/0506
Ethics committee name [2] 2830 0
The Northern Hospital HREC
Ethics committee address [2] 2830 0
Ethics committee country [2] 2830 0
Australia
Date submitted for ethics approval [2] 2830 0
Approval date [2] 2830 0
28/03/2006
Ethics approval number [2] 2830 0
08/06

Summary
Brief summary
Antenatal depression, anxiety and the difficulties associated with adjusting to parenthood can have long-term negative effects on parents and their children. This study will test whether an 8-week self-help antenatal intervention with telephone support will reduce postnatal negative mood and parenting stress, increase health service uptake, as well as facilitate adjustment to parenthood in couples receiving the program compared to couples not receiving the program. 100 women with elevated scores (>12) on the Edinburgh Postnatal Depression Scale (EPDS) and/or the Risk Assessment Checklist (RAC) and their partners, and 100 women with scores below the threshold (<13) on the EPDS and the RAC and their partners will be randomised to either intervention or control groups. Participants will be assessed by self-administered questionnaires at 20-32 weeks of pregnancy and 12 weeks postpartum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35590 0
Address 35590 0
Country 35590 0
Phone 35590 0
Fax 35590 0
Email 35590 0
Contact person for public queries
Name 10355 0
Ms Jennifer Ericksen
Address 10355 0
Parent-Infant Research Institute (PIRI)
Department of Clinical & Health Psychology
Heidelberg Repatriation Hospital
Austin Health
300 Waterdale Rd
Heidelberg West, VIC 3081
Country 10355 0
Australia
Phone 10355 0
+61 (03) 9496 4496
Fax 10355 0
+61 (03) 9496 4148
Email 10355 0
[email protected]
Contact person for scientific queries
Name 1283 0
Professor Jeannette Milgrom
Address 1283 0
Parent-Infant Research Institute (PIRI)
Department of Clinical & Health Psychology
Heidelberg Repatriation Hospital
Austin Health
300 Waterdale Rd
Heidelberg West VIC 3081
Country 1283 0
Australia
Phone 1283 0
+61 (03) 9496 4496
Fax 1283 0
+61 (03) 9496 4148
Email 1283 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.