Pre-birth assessments for women who use substances in pregnancy

The Willow Study: pre-birth assessments for women who use substances in pregnancy: women and social work views and experiences

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17435564

Enrollment

Registered

2025-07-23

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Substance use/treatment for substance use in pregnancy in women who undergo pre-birth assessments with Children's Services Pregnancy and Childbirth

Interventions

This is a mixed-method study design involving qualitative interviews and focus groups with women and practitioners and quantitative data analysis over 3 sites (2 in England and 1 in Wales). The mixed-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for women: 1. Age 18 or over 2. Able to give informed consent 3. Experience of a pre-birth assessment in the last 12 months or currently undergoing assessment. Inclusion criteria for professionals: Any professional involved in undertaking pre-birth assessments for women within the three local authorities

Exclusion criteria

Exclusion criteria: Unable to give informed consent 1. Not had a pre-birth assessment within 12 months 2. Not used / in treatment for substance use For professionals: Not involved in pre-birth assessments

Design outcomes

Primary

Measure	Time frame
The primary outcome measures are assessed through the secondary analysis of social care records. Local authority data officers will extract routinely collected data from their records. Quantitative outcomes 1. Pre-birth assessments measured using logistic regression to identify predictors 2. Care status of baby measured using logistic regression with random intercepts to account for nested data 3. Population profile characteristics (e.g. age, ethnicity) measured using descriptive statistics 4. Predictors of pre-birth assessments measured using logistic regression after propensity score matching (1:1 and 1:4 ratios) 5. Impact of missing data assessed using imputation and complete case analysis Qualitative Outcomes 1. Themes and meanings from qualitative data identified using reflexive thematic analysis 2. Insights from stakeholder perspectives (mothers and practitioners) explored through stakeholder workshops and used to co-develop recommendations	—

Measure

Time frame

The primary outcome measures are assessed through the secondary analysis of social care records. Local authority data officers will extract routinely collected data from their records. Quantitative outcomes 1. Pre-birth assessments measured using logistic regression to identify predictors 2. Care status of baby measured using logistic regression with random intercepts to account for nested data 3. Population profile characteristics (e.g. age, ethnicity) measured using descriptive statistics 4. Predictors of pre-birth assessments measured using logistic regression after propensity score matching (1:1 and 1:4 ratios) 5. Impact of missing data assessed using imputation and complete case analysis Qualitative Outcomes 1. Themes and meanings from qualitative data identified using reflexive thematic analysis 2. Insights from stakeholder perspectives (mothers and practitioners) explored through stakeholder workshops and used to co-develop recommendations

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom, Wales

Contacts

Public ContactShirley Lewis

s.j.lewis@sheffield.ac.uk+44 (0)114 222 2409

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026