Mellow Babies - a Pilot Waiting List Trial
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|ClinicalTrials.gov Identifier: NCT02277301|
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mothers Who Have Been Referred for Parenting Support||Behavioral: Mellow Babies||Not Applicable|
Psychologically informed very early intervention programmes across the ante- and postnatal period have shown promise in delivering cost-effective long term positive outcomes. There is robust support for the view that early intervention to prevent and manage difficulties in the parent-infant relationship may produce long-term benefits such as reduction in rates of criminality, substance abuse and educational underachievement. A meta-analysis of sensitivity and attachment interventions in early childhood has shown that the most effective interventions use a moderate number of sessions (n=5-16) and are focussed on parental sensitivity.
Although Mellow Parenting interventions (Mellow Babies is probably the best-evidenced) are quite widely used in a number of countries, no definitive randomised trials have been carried out. To date there has been a single small waiting list trial suggesting improvement in maternal mood and mother-child interaction, We aim to inform the design of a definitive RCT with a waiting-list control trial with adequate power to estimate an effect size.
This is a parallel randomised open-label blinded end-point (PROBE) clinical trial with a waiting-list control group. The study will be conducted in three areas: Lisburn, North Down & Ards, and Downpatrick. At least 50 women with infants under 18 months old will be recruited in September 2014. Participating women will be given information on the study, in particular being informed that participation would involve either receiving the intervention the following month or after a delay of 20 weeks. Signed consent (which will include consent to follow up after one year, beyond the timespan of this study) will be sought after an interval of at least 24 hours to allow the women to arrive at an informed decision.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mellow Babies - a Pilot Waiting List Trial|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Mellow Babies
Mellow Babies is a group day programme, run one day a week over 14 weeks with a joint focus on maternal wellbeing and the parentinfant interaction: transport and crèche facilities are provided.The focus is to: (a) explicitly enhance close mother-infant attunement, using a combination of baby-massage, interaction coaching and infant focussed speech; and (b) offer mothers support for their own distress. Mellow Babies is an intervention designed for mothers with substantial problems in their relationships with their infants. Typically, participating mothers have mental health difficulties, problem drug use, learning difficulties, forensic issues or they may have children already looked after by the local authority.
Behavioral: Mellow Babies
Mellow Babies is an intervention designed for mothers with substantial problems in their relationships with their infants. Typically, participating mothers have mental health difficulties, problem drug use, learning difficulties, forensic issues or they may have children already looked after by the local authority.
Other Name: Mellow Parenting
No Intervention: Care as Usual
Routine care received by mothers with substantial problems in their relationships with their infants. Typically, participating mothers have mental health difficulties, problem drug use, learning difficulties, forensic issues or they may have children already looked after by the local authority.
- Mellow Parenting Observation System (MPOS). [ Time Frame: 16-18 weeks ]MPOS, is an event sampled observational system in which the rate of positive and negative parenting behaviours is calculated.
- The Adult Wellbeing Scale (Snaith et al 1978) [ Time Frame: 16-18 weeks ]The Adult Wellbeing Scale is based on the Hospital Anxiety and Depression Scale which is used to determine the levels of anxiety and depression that a patient is experiencing.
- The Edinburgh Postnatal Depression Scale (Cox et al 1987) - [ Time Frame: 16-18 weeks ]The Edinburgh Postnatal Depression Scale is the standard clinical screening tool for postnatal depression, widely used by health visitors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277301
|Lisburn Health Centre|
|Lisburn, United Kingdom, BT28 1LU|
|Principal Investigator:||Lucy Thompson, BA PhD MPH||University of Aberdeen|