Parents and communities together (PACT)
| ISRCTN | ISRCTN21987651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21987651 |
| Protocol serial number | 182843 |
| Sponsor | King's College London |
| Funders | Guy's and St Thomas' Charity, King’s College London |
- Submission date
- 01/03/2017
- Registration date
- 20/03/2017
- Last edited
- 11/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
From pregnancy onwards, the negative effects of social inequality and adversity effect children’s long-term physical health, mental well-being, and emotional, cognitive, and behavioural development. Recent reports suggest that early interventions are the most effective way of addressing these lifelong issues. This is because social inequality and adversity begin to affect children before birth due to a combination of factors including nutrition, isolation, parental stress, access to services, and parenting environment. Research suggests that increasing social support for parents and in communities would be the most effective way to address the factors leading to poor outcomes in children. This is a new early intervention public health project for pregnant mothers and their infants which applies developmental health science through community organizing in order to improve the health outcomes for the next generation. In 2013, a small study was launched based on input from local mothers, health professionals, and academic research. This resulted in community-led support groups and educational workshops led by parents and professionals. The initiative was found to be acceptable to participants, feasible, and showed promising improvements in maternal stress and health knowledge. The primary aim of the current study is to produce robust evidence of the intervention’s effect on the mental health, health literacy, and social capital of mothers, as well as the physical and cognitive development of their infants. The secondary aim is to develop a framework for this radical model of practice that communities and parents can expand upon, and discover if this new approach is worth exploring and using widely.
Who can participate?
Pregnant women between 22 - 34 weeks gestation attending midwifery clinics in Camberwell, Walworth and Bermondsey areas of Lambeth and Southwark
What does the study involve?
Participants recruited from the midwifery clinics covering the Camberwell and Walworth areas are invited to attend community support and education groups. The groups are free of charge and consist of “Parent University,” an educational group run by parents and health visitors discussing pregnancy, birth, breastfeeding, weaning, emotional health, and other parenting issues, as well as “Mumspace,” a play group designed to foster social support amongst mothers. Participants recruited from midwifery clinics covering the Bermondsey and Rotherhithe area do not receive the intervention but have access to any available resources for pregnant mothers in their area, excluding the resources mentioned above. All participants complete assessments with a research midwife at their home at recruitment, 6 months after birth, and 12 months after birth. Each of these visits is expected to last from one to three hours, and data is collected about the mother’s mental health, social capital, financial and health literacy, as well as physical and developmental outcomes with the infants after birth.
What are the possible benefits and risks of participating?
The benefits for participants include having easier access to health knowledge, relevant services, child play groups, community leadership, and social support through relationships formed with other mothers. If the study yields positive results, this project may be offered on a larger scale to mothers living throughout the UK. Your involvement may therefore benefit future mothers across the country. No risks are anticipated in taking part. The researchers liaise with midwifery teams about the pregnancy status of participants during and after recruitment to ensure no unexpected problems such as miscarriage have occurred. However, the participants are pregnant mothers and if they are assessed to have health risks, they are referred to specialist NHS services. Some questions in the questionnaires may be distressing, and participants are fully briefed beforehand. If they show signs of distress, the research midwife offers support, signposts the mother to appropriate services, pauses the assessment or has the mother withdrawn from the study.
Where is the study run from?
1. King's College Hospital NHS Foundation Trust (UK)
2. Guy's and St Thomas' NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2015 to February 2018
Who is funding the study?
1. Guy’s & St Thomas’ Charity
2. King’s College London
Who is the main contact?
Dr Derek Bolton
Contact information
Public
Henry Wellcome Building
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Matched case-control study |
| Secondary study design | Case-control study |
| Participant information sheet | ISRCTN21987651_PIS_Control_V3_22Sep15.docx |
| Scientific title | Parents And Communities Together (PACT): strengthening local babies’ futures by community-led action |
| Study acronym | PACT |
| Study objectives | The main hypothesis is that mothers allocated to the community intervention group will show improved maternal social capital, mental health, and health literacy, as well as comparatively better infant health and developmental outcomes in the first 12 months than the infants in the control group. |
| Ethics approval(s) | NHS National Research Ethics Service Committee London–Fulham, 12/02/2016, ref: 15/LO/1227 |
| Health condition(s) or problem(s) studied | Mental health, health literacy and social capital |
| Intervention | Participants recruited from the Camberwell and Walworth will be allocated to receive the intervention which is comprised of two components: 1. The social support network will comprise three main hubs, one established during the Pilot at Camberwell Salvation Army, at St Michaels and All Angels church in Camberwell, and the third in Walworth, based at a Primary School. The hubs will host parent-led weekly meetings with provided childcare assistance during attendance. This is to provide an accessible and non-judgmental space for themed discussions about children, parenting, and personal concerns, facilitating mutual social support among the mothers. 2. The second component involves 12 health education workshops co-ordinated by a health visitor but are parent-led with input from experts (e.g. midwives) and professionals as required. The first two sessions are ante-natal and the following sessions are ante and post-natal. The workshops will cover mental health and parents, how hormones impact on feelings, health behaviours that benefit baby’s healthy development, nutrition, infant learning, and parenting skills. This format and syllabus was co-developed with health care professionals and parents in the pilot study, the latter requesting a need for health education and a place to share concerns. Participating mothers will also be supported by a Citizens UK organiser to work together with other parents to advocate on health literacy topics, to express views to health services and commissioners, and tackle community issues they have identified that inhibit the wellbeing of parents and babies in Camberwell and Walworth - issues pertaining to the wider social determinants of health. As was found in the pilot, it is expected that the community-led groups will involve and grow according their participants. However, the two evidence-based features of the intervention (social support and health education) will remain as the core components of the intervention. Women recruited in the Bermondsey and Rotherhithe area will be allocated to the control group and will receive no intervention. They will have access to any available resources for pregnant mothers in their area, excluding the resources mentioned above. All participants complete assessments with a research midwife at their home: at recruitment, 6 months after birth, and 12 months after birth. Each of these visits is expected to last from one to three hours, and where data is collected about the mother’s mental health, social capital, financial and health literacy, as well as physical and developmental outcomes with the infants after birth. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Maternal mental health: |
| Key secondary outcome measure(s) |
1. Parenting, measured at baseline, 6 months after birth: |
| Completion date | 28/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 134 |
| Total final enrolment | 136 |
| Key inclusion criteria | 1. Pregnant women between 21-26 weeks gestation 2. Attending midwifery clinics in Camberwell, Walworth and Bermondsey areas of Lambeth and Southwark 3. The infants cared for by these women 4. Aged 19 or over |
| Key exclusion criteria | 1. Suitable for referral to specialist services according to current guidance, e.g. below 19 years old, referred to local Family Nurse Partnership, history of or current depression to specialist mental health 2. Living in postcodes that will be invited to take part in Lambeth Early Action Partnership (LEAP is a Big Lottery funded initiative nearby) |
| Date of first enrolment | 27/04/2015 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
London
SE1 7EH
United Kingdom
London
SE5 8AF
United Kingdom
45-47 Caldecot Road
London
SE5 9RS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/04/2020 | 11/08/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | evaluation | 07/04/2020 | 11/08/2020 | Yes | No |
| Participant information sheet | version V3 | 22/09/2015 | 20/03/2017 | No | Yes |
| Participant information sheet | version V2 | 07/08/2015 | 20/03/2017 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN21987651_PIS_Control_V3_22Sep15.docx
- Uploaded 20/03/2017
- ISRCTN21987651_PIS_Intervention_V2_07Aug15.docx
- Uploaded 20/03/2017
Editorial Notes
11/08/2020: Publication references added.
26/07/2019: Total final enrolment number added.
20/03/2017: Participant information sheets uploaded.
