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The Mellow Babies Trial

Does "Mellow Babies" improve the psychosocial health of mothers and their children? The Mellow Babies Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47575326
Enrollment
212
Registered
2019-01-30
Start date
2019-01-21
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mothers who are having difficulties in their relationship with their baby. Mothers’ feelings of wellbeing (depression, anxiety, stress, etc), and the way mothers interact with their baby Other

Interventions

Participants are randomised to either the Mellow Babies group-based parenting programme (MB) plus Usual Care or Usual Care. Mothers are randomised (following consent) and screened to ensure inclusion

Sponsors

University of Aberdeen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 52 Years

Inclusion criteria

Inclusion criteria: 1. Mothers with principal caregiving responsibilities scoring >11 on HADS-A or >7 on HADS-D 2. With a child who will be aged 6-18 months at the time of randomisation 3. Living in Highland Council region

Exclusion criteria

Exclusion criteria: 1. Current substance dependence 2. Inability to complete questionnaires or participate in groups because of limited English language comprehension 3. Child with learning difficulties sufficient to make outcome assessment impossible 4. Mother has already participated in the trial (e.g., second eligible baby within life of the study) 5. Mother under 16 years

Design outcomes

Primary

MeasureTime frame
Maternal mental health measured using self-complete Hospital Anxiety and Depression Scale (HADS) at 8 months post randomisation and when children are 30 months old

Secondary

MeasureTime frame
At 8 months post-recruitment: 1. Child’s expressive language performance in the 50-word Sure Start Language Measure (SSLM) 2. Child’s overall social and emotional development measured with Brief Infant-Toddler Social and Emotional Assessment (BITSEA) 3. Caregiver accounts of the experience of interventions measured using participant interviews 4. Participants’ service use and out of pocket expenses measured using bespoke Participant Cost Questionnaire 5. Mothers’ quality of life as measured by EQ-5D-5L 6. Positive and negative parenting behaviours during a videoed family meal using the Mellow Parenting Observational System (MPOS) At 30 months of age: 1. Child’s social and emotional functioning as measured by the total difficulties scale of the maternally-reported SDQ at age 30 months 2. Specific aspects of child’s social and emotional functioning as measured by the emotional problems, conduct problems, hyperactivity/inattention and peer relationship problems, and prosocial behaviour subscale of the SDQ 3. Child’s expressive language performance in the 50-word Sure Start Language Measure (SSLM) 4. Child’s overall development the Bayley III Scales of Infant and Toddler Development (65), including Behavior Observation Inventory 5. Positive and negative parenting behaviours during a videoed family meal using the Mellow Parenting Observational System (MPOS) 6. Within-trial cost analysis of participants’ service use and out of pocket expenses using bespoke Participant Cost Questionnaire 7. Cost-consequence analysis of the MB intervention vs usual care 8. Mothers’ quality of life as measured by EQ-5D-5L 9. Satisfaction with intervention/usual care measured using participant feedback questionnaire and interviews

Countries

Scotland, United Kingdom

Contacts

Public ContactFrances Hines
frances.hines@nhs.scot+44 (0)1463 255822

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026