Mothers Who Have Been Referred for Parenting SupportNCT02277301
Mellow Babies - a Pilot Waiting List Trial
A study testing Mellow Babies in people with Mothers Who Have Been Referred for Parenting Support, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This is a mixed-methods study centred on a prospective randomised openlabel blinded endpoint (PROBE) pilot clinical trial with a waitinglist control group. The study will be conducted in three areas of Northern Ireland: Lisburn, North Down \& Ards, and Downpatrick. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Mothers Who Have Been Referred for Parenting Support
- What is being tested?
- Mellow Babies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mothers of infants aged less then 13 months who have been referred for parenting support by the health or social care services.
Who cannot join
- Those unable to complete research assessments (due to literacy or language issues).
Trial locations and contacts
1 site in 1 country.
About this study
This is a mixed-methods study centred on a prospective randomised openlabel blinded endpoint (PROBE) pilot clinical trial with a waitinglist control group. The study will be conducted in three areas of Northern Ireland: Lisburn, North Down \& Ards, and Downpatrick. At least 50 women with infants under 13 months old will be recruited during August/September 2014.
Read the detailed description
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.
- Being tested
- Mellow Babies
- Keywords
- Pilot study, Randomised Controlled Trial, Parenting, Paediatrics, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mellow BabiesBehavioural
Also called Mellow Parenting
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.
| Study group | Role | What they receive |
|---|---|---|
| Mellow Babies | Experimental | 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. Receives: Behavioral: Mellow Babies |
| Care as Usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mellow Parenting Observation System (MPOS).
MPOS, is an event sampled observational system in which the rate of positive and negative parenting behaviours is calculated.
Measured: 16-18 weeks
Secondary outcomes (1)
The Adult Wellbeing Scale (Snaith et al 1978)
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.
Measured: 16-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mothers Who Have Been Referred for Parenting SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- South Eastern Health and Social Care Trust
- Responsible party
- Principal investigator, Dr Lucy Thompson, University of Aberdeen
- Investigators
- Lucy Thompson, BA PhD MPH, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277301
- Sponsor's protocol ID
- 2/033/14
- Status last verified
- Apr 2019
- First submitted
- 24 Oct 2014
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Thompson L, Wilson P. Mellow Babies: A Randomised Feasibility Trial of an Intervention to Improve the Quality of Parent-Infant Interactions and Parental Mental Wellbeing. Children (Basel). 2024 Apr 24;11(5):510. doi: 10.3390/children11050510.
PubMed 38790505
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mellow Babies - a Pilot Waiting List Trial
- ClinicalTrials.gov ID
- NCT02277301
- Acronym / sponsor ID
- 2/033/14
- Keywords
- Pilot study, Randomised Controlled Trial, Parenting, Paediatrics, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- South Eastern Health and Social Care Trust
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a mixed-methods study centred on a prospective randomised openlabel blinded endpoint (PROBE) pilot clinical trial with a waitinglist control group. The study will be conducted in three areas of Northern Ireland: Lisburn, North Down \& Ards, and Downpatrick. At least 50 women with infants under 13 months old will be recruited during August/September 2014.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mellow Babies | Experimental | Behavioral: Mellow BabiesMellow 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. |
| Care as Usual | No intervention | –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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Mothers of infants aged less then 13 months who have been referred for parenting support by the health or social care services.
Key exclusion criteria (1 listed)
- Those unable to complete research assessments (due to literacy or language issues).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mellow BabiesAlso: Mellow ParentingMellow 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. | Behavioural | Mellow Babies |
Primary outcome
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.
1 secondary outcome
The Adult Wellbeing Scale (Snaith et al 1978)
Time frame: 16-18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 38790505Thompson L, Wilson P. Mellow Babies: A Randomised Feasibility Trial of an Intervention to Improve the Quality of Parent-Infant Interactions and Parental Mental Wellbeing. Children (Basel). 2024 Apr 24;11(5):510. doi: 10.3390/children11050510.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Thompson, BA PhD MPH principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mellow Babies in people with Mothers Who Have Been Referred for Parenting Support, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mellow Parenting Observation System (MPOS). (time frame: 16-18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02277301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019; AzTrials last refreshed its copy on 29 Oct 2026.