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Right from the start: Improving outcomes for children born to mothers in difficult circumstances

Right from the start: Protocol for a pilot study for a randomised trial of the New Baby Programme for improving outcomes for children born to socially vulnerable mothers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35456296
Enrollment
50
Registered
2017-02-28
Start date
2016-04-01
Completion date
Unknown
Last updated
2018-02-26

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

Conditions

Child development, maternal health and maternal-child relationships Mental and Behavioural Disorders Child development, maternal health and maternal-child relationships

Interventions

Participants are randomised to one of two groups using a central computer randomisation service (TENALEA). Intervention group: Participants receive a manualised home visiting programme providing enha

Sponsors

Queen's University, Belfast
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. First time pregnant mothers aged over 19 years, or multiparous women of any age presenting with socially complex circumstances, defined as one or more of the following 1.1. Social isolation/low family support/father in prison 1.2. Intimate partner violence 1.3. Substance misuse 1.4. Maternal stress or history of mental ill health 1.5. Current involvement with social services or probation 1.6. History of care or a care leaver 1.7. Abnormal reaction to pregnancy. 2. Capacity to provide informed consent

Exclusion criteria

Exclusion criteria: 1. First time mothers under 19 years 2. Mothers experiencing no socially complex circumstances

Design outcomes

Primary

MeasureTime frame
Parent-child relationship is assessed by measuring maternal sensitivity using the CARE-Index and child attachment using the Ainsworth Strange Situation Procedure (SSP) at baseline and 12 months.

Secondary

MeasureTime frame
Mother: 1. Parental mental health is measured using the Revised Prenatal Distress Questionnaire (NuPDQ) at 20 weeks gestation (baseline), the Edinburgh Post Natal Depression Scale (EPD) and the State-Trait-Anxiety Inventory (STAI-S-6) at baseline and when infant is aged 2, 6 and 12 months old, and the Parenting Stress Index at baseline and when infant is 2 and 12 months old 2. Smoking and substance use are measured using a series of brief questions at baseline, and when infant is 2, 6 and 12 months of age 3. Maternal quality of life is measured using the EuroQol (EQ-5D-DL) at baseline, and when infant is 2-, 6- and 12 months of age 4. Mother's sense of competence is measured using the Perceived Parenting Competence Scale (PSOC) when infant is 2 months and 12 months 5. Relationships violence is measured using brief questions at baseline and when infant is 12 months old 6. Social support networks are measured using the Medical Outcomes Study (MOS) Social Support Survey - short form 36, at baseline and when the infant is 12 months old Child: 1. Child development is measured using the Mullen Scales of Early Learning when the infant is 2, 6 and 12 months of age 2. Service use will be measured by collecting information when the infant is 2, 6 and 12 months of age

Countries

United Kingdom

Contacts

Public ContactGeraldine Macdonald
Geraldine.Macdonald@bristol.ac.uk+44 (0)1179546729

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026