Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001517167
Ethics application status
Approved
Date submitted
29/08/2019
Date registered
4/11/2019
Date last updated
4/11/2019
Date data sharing statement initially provided
4/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cradle to Kinder: A Qualitative and Quantitative Evaluation of a Maternal and Child Health Intervention for Disadvantaged Young Mothers
Scientific title
Cradle to Kinder: A Prenatal and Postnatal Support Program for Young Mothers to Improve both Maternal and Infant Outcomes
Secondary ID [1] 299017 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal health and wellbeing 314046 0
Infant health and wellbeing 314754 0
Condition category
Condition code
Reproductive Health and Childbirth 312435 312435 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cradle to Kinder Intervention.
Cradle to Kinder is a targeted, intensive and long-term ante- and postnatal support service for vulnerable young mothers (aged less than 25 years) and their families commencing from pregnancy (at 30 weeks) until the child is four years old. Cradle to Kinder comprises a series of home visits, where each family is allocated their own Cradle to Kinder key worker (a trained social worker) who visits the family home once a week, on average, for approximately 1.5 hours. On average, frequency of contact is weekly or fortnightly home visits with regular phone contact in between, depending on the family’s need. The phone conversations are guided by the needs of the client and can include the following: reminder of strategies discussed during previous interactions, active listening and responding and reminders regarding upcoming appointments and meetings. Cradle to Kinder may also involve responding to unexpected or crisis situations that may arise over time during which the family will likely to require additional program support and frequency of contact. In home visits, the Cradle to Kinder practitioner implements interventions to support the family through their multiple and complex needs. Evidence-based intervention strategies that may be implemented during home visits include infant-parent relationship building, safety in the home, psycho-education, feeding practices, developing routines, improving caregiver sensitivity and responsively, and building practical parenting skills to respond to and manage varying behaviours. These interventions are delivered using verbal discussions, educational brochures and observational modelling.
Adherence to the intervention was reported in the key worker's case notes after each visitation which asks the worker to complete the content of the intervention delivered, duration of visitation and any other observations they need to report.
Intervention code [1] 315306 0
Prevention
Intervention code [2] 315764 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321087 0
Maternal health outcomes as assessed by the North Carolina Family Assessment scale (NCFAS) which includes 7 sub scales *Note this could not be included as seperate primary outcomes as only 2 were allowed

1. Environment 2. Parental capabilities 3. Family interactions 4. Family safety 5. Child wellbeing 6. Social/community life 7. Family health 8. Self-sufficiency
Timepoint [1] 321087 0
Every 6 months from engagement in the program (30 weeks pregnant) until when the child is 4 years of age
Secondary outcome [1] 373937 0
Infant health outcomes using the Brigance survey tool
Timepoint [1] 373937 0
Every 6 months from birth to 4 years of age

Eligibility
Key inclusion criteria
Pregnant women, aged under 25 years, with at least one risk factor, including: drug and alcohol use; mental health issues; experience of out-of-home care; low socioeconomic status; learning difficulty; child protection involvement; or experience of domestic violence. Mothers are eligible if there are concerns for the safety and wellbeing of their unborn child. If the mother is under the age of 18 then their guardian is required to provide consent.
Minimum age
16 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Mothers aged over 25
Not English speaking
Families who do not reside within the Child FIRST catchment area

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/07/2017
Date of last participant enrolment
Anticipated
10/09/2020
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
50
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303551 0
Commercial sector/Industry
Name [1] 303551 0
MacKillop Family Services
Country [1] 303551 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 1, 43-51 Kanooka Grove
Clayton VIC 3168
Australia
Country
Australia
Secondary sponsor category [1] 303653 0
None
Name [1] 303653 0
Address [1] 303653 0
Country [1] 303653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304082 0
Monash University Human Research Ethics Committee'
Ethics committee address [1] 304082 0
Monash University Human Research Ethics Committee (MUHREC)
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 304082 0
Australia
Date submitted for ethics approval [1] 304082 0
Approval date [1] 304082 0
11/06/2017
Ethics approval number [1] 304082 0

Summary
Brief summary
Young disadvantaged mothers are at a higher likelihood of having their child/children removed from their care, which results in poor psychosocial outcomes for the mother and the infant. Therefore, a prospective cohort study will be conducted to evaluate the efficacy of the Cradle to Kinder program on psychosocial outcomes among young and vulnerable families. An anticipated sample of 50 young at-risk women and their families will receive the Cradle to Kinder program, commencing from pregnancy up until the child turns four years old, Cradle to Kinder is a targeted, intensive and long-term ante- and postnatal support service for vulnerable young mothers (aged less than 25 years with one or more risk factors) and their families. Cradle to Kinder practitioners will conduct weekly to fortnightly home visits and engage families in a range of different interventions to support and facilitate health outcomes. Assessments will be conducted by the practitioner at baseline and then every six months over the four years of the intervention. Maternal health outcomes (i.e., mental health, parenting capacity) will be measured using the North Carolina Family Assessment Scale, and infant outcomes (i.e., attachment style, social and emotional development) will be assessed by the Brigance. It is expected that families who engage in the program for its entire duration will demonstrate better psychosocial outcomes at the conclusion of the program compared to the beginning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95754 0
Dr Renee O'Donnell
Address 95754 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Grove
Clayton VIC 3168
Australia
Country 95754 0
Australia
Phone 95754 0
+61 0422984527
Fax 95754 0
Email 95754 0
[email protected]
Contact person for public queries
Name 95755 0
Dr Renee O'Donnell
Address 95755 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Grove
Clayton VIC 3168
Australia
Country 95755 0
Australia
Phone 95755 0
+61 0422984527
Fax 95755 0
Email 95755 0
[email protected]
Contact person for scientific queries
Name 95756 0
Dr Renee O'Donnell
Address 95756 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Grove
Clayton VIC 3168
Australia
Country 95756 0
Australia
Phone 95756 0
+61 0422984527
Fax 95756 0
Email 95756 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
Individual findings are not of interest. Instead, overall group patterns in the data will be reported to both participants and in any papers generated from the project. A summary of results will be made available to participants. No participant will be identified in the dissemination of the findings as only group findings will be published.


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.