Does infant carrying in a soft carrier promote secure infant attachment and maternal care? A randomised controlled clinical trial

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Richard Neal
Scientific

Honor Oak Health Centre
20 Turnham Rd, Brokley
London
SE4 1JN
United Kingdom

Phone	+44

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2007
Reason abandoned (if study stopped)	Not started, awaiting approval/ funding

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2005
Date of final enrolment	30/09/2007

Honor Oak Health Centre

London
SE4 1JN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan