Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0125146731
Study information
Scientific title
Acronym
Study hypothesis
1. Does use of a soft baby carrier promote mother-infant sensitivity?
2. Does soft baby carrier use promote secure infant attachment in children from a variety of family backgrounds who would otherwise be at high risk of developing an insecure attachment?
As of June 2008: trial has not started.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Neonatal Diseases
Intervention
1. Experimental: Provision of soft baby carrier(s) appropriate for infant carriage against the trunk for the first six months after birth, with ongoing encouragement to use for 2 hours daily.
2. Control: Provision of infant clothing vouchers.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. The means of measures of 3 axes of maternal care - the Care Index (Crittenden, 1992) at 3 months.
2. The proportions of experimental and control groups with secure attachment - Strange Situation Test at 13 months (Ainsworth, 1978).
3. Actual duration and intensity of soft baby carrier use at 1, 3, 5, 8 and 13 months.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2005
Overall trial end date
30/09/2007
Reason abandoned
Not started, awaiting approval/ funding
Eligibility
Participant inclusion criteria
Mothers of newborns that are eligible and give informed consent will be randomly assigned to the experimental or the control group, based on revealing the next in a series of random numbers.
Women who deliver a singleton live infant in the delivery suite of a large, inner-city hospital, aged 16+, accessible by telephone, able to speak conversational English, and not planning to move out of the area within 15 months will be eligible for participation in the study.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2005
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Honor Oak Health Centre
London
SE4 1JN
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Lewisham Research Unit (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary