Does infant carrying in a soft carrier promote secure infant attachment and maternal care? A randomised controlled clinical trial
| ISRCTN | ISRCTN77549531 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77549531 |
| Secondary identifying numbers | N0125146731 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/04/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Neonatal Diseases
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
Contact information
Dr Richard Neal
Scientific
Scientific
Honor Oak Health Centre
20 Turnham Rd, Brokley
London
SE4 1JN
United Kingdom
| Phone | +44 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/01/2005 |
| Completion date | 30/09/2007 |
| Reason abandoned (if study stopped) | Not started, awaiting approval/ funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Honor Oak Health Centre
London
SE4 1JN
United Kingdom
SE4 1JN
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Lewisham Research Unit (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
