Trial of Healthy Relationship Initiatives for the Very Early-years

Plain English Summary

Background and study aims
Evidence shows that social deprivation and/or high levels of stress, anxiety and depression during pregnancy can negatively affect the developing foetus and result in permanent changes to a baby’s ability to cope with stress. This can affect a mother’s ability to form a sensitive and nurturing bond with her baby which, in turn, can increase the risk of child maltreatment. Additionally, social deprivation and maternal mental ill-health have long-term negative effects on children’s health, social and educational outcomes. Parenting interventions show promising improvements in child outcomes. However, most are delivered after the birth (postnatal) and there is little evidence from the UK on the effectiveness of interventions delivered before the birth (antenatal) amongst women with additional health and social care needs.
This study aims to evaluate whether attending one of two antenatal parenting support programmes, Enhanced Triple P for Baby or Mellow Bumps, in addition to routine NHS antenatal and postnatal care (care as usual) helps to reduce maternal anxiety, depression and irritability and improve mother-child interactions compared to those who only receive care as usual.

Who can take part?
Women with additional health and social care needs in pregnancy residing in the NHS Greater Glasgow and Clyde and Ayrshire and Arran Health Board areas.

What does the study involve?
Women are recruited to the study after their 12th week of pregnancy. All women complete a questionnaire before the start of the study which collects demographic information and measurements of psychological distress, health status, anxiety and depression. The women are then randomly allocated to one of three groups: Enhanced Triple P for Baby, Mellow Bumps or Care As Usual. All participants receive routine NHS antenatal and postnatal care throughout their involvement in the trial. Women allocated to Enhanced Triple P for Baby and Mellow Bumps start the programmes when they are between 20 and 30 weeks pregnant. Further data is collected from the women when their babies are 6 months old using a questionnaire that includes assessments of maternal anxiety, depression and irritability. Parenting self-efficacy and maternal sensitivity, measured by analysis of video recordings, are assessed at the follow-up visits. Consent is requested for the collection of long-term health, social and educational outcomes using routine data sources (e.g., GP/social work records). Data is compared from the three groups over the course of the trial to determine if Enhanced Triple P for Baby or Mellow Bumps have an impact on maternal mental health and the mother-infant relationship.

What are the possible benefits and risks of participating?
Participants are given a £15 voucher at each data collection timepoint. Participants allocated to the intervention arms may receive benefits from the parenting support programmes such as improved mental wellbeing and improved mother-child relationship.
We do not expect that taking part will hold any risk for the participants. Participants are allowed to leave the study at any time and without giving any reason. If any distress is caused the researchers contact the health professional caring for the participant and they also offer them a contact for the appropriate support service they may need.

Where is the study run from?
The study is conducted in NHS Greater Glasgow and Clyde and NHS Ayrshire and Arran Health Board areas, UK.
The study is being carried out by a team of experienced researchers based at the Medical Research Council/Chief Scientist Office, Social and Public Health Sciences Unit, University of Glasgow in conjunction with other researchers at the University of Glasgow, Glasgow Caledonian University, University of Manchester, University of Newcastle, University of Aberdeen and Greater Glasgow and Clyde Health Board.

When is the study take place and how long is it expected to run for?
December 2013 - July 2019

Who is funding the study?
The National Institute of Health Research (NIHR), UK.

Who is the main contact?
Dr Marion Henderson
marion.henderson@glasgow.ac.uk

Trial website

http://thrive.sphsu.mrc.ac.uk

Type

Scientific

Primary contact

Dr Marion Henderson

ORCID ID

http://orcid.org/0000-0001-7582-9516

Contact details

MRC/CSO Social and Public Health Sciences Unit
University of Glasgow
200 Renfield Street
Glasgow
G2 3QB
United Kingdom
+44 (0)141 353 7526
marion.henderson@glasgow.ac.uk

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol number: GN12KH589 / NIHR number: 11/3002/01

Scientific title

Trial of Healthy Relationship Initiatives for the Very Early-years (THRIVE): a three-arm randomised controlled trial for mothers identified as vulnerable in pregnancy and their babies who are at high risk of maltreatment

Acronym

THRIVE

Study hypothesis

We propose that the parenting support programmes, Enhanced Triple P for Baby and Mellow Bumps, will be effective in lowering depression, anxiety and outwardly directed irritability and encourage the development of sensitive and attuned mother-infant relationships in pregnant women with additional health and social care needs. Enhanced Triple P for Baby and Mellow Bumps will lead to improvements in infant language development, long-term infant health, socio-emotional and educational outcomes and changes in the number of children flagged as ‘at risk’ on the social services risk register. In addition, we propose that Enhanced Triple P for Baby and Mellow Bumps will be cost-effective for the NHS and society more broadly, in the long-term.

Ethics approval

NHS West of Scotland Research Ethics Service, 21/08/2013, ref: 13/WS/0163

Study design

Longitudinal three-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

See additional file

Condition

Maternal mental health; parenting; attachment; child maltreatment; child language development; early years; antenatal intervention; social deprivation; pregnancy; child development

Intervention

Current interventions (as of 09/04/2018):
This trial will compare two antenatal parenting interventions with routine care using outcome, process and health economics evaluation.

Enhanced Triple P for Baby
Enhanced Triple P for Baby is a transition to parenthood intervention which aims to provide babies with a healthy start to life, by combining parenting skills training with strategies to enhance individual wellbeing and couple adjustment. It is informed by social learning theory and has evolved from the universally designed Triple P for Baby. The ‘enhanced’ level has been designed to address the specific health and social care needs of vulnerable women and their families. Group sessions focus on encouraging couples to work together to develop the skills needed to maintain a harmonious family. The women’s partners are invited to all of the group sessions. The programme consists of four two-hour antenatal group sessions, up to three one-hour postnatal sessions which are delivered on a one-to-one basis in person and an optional post-natal group session. The first antenatal session is delivered when women are between 20-30 weeks pregnant, and the postnatal sessions are delivered from when infants are 6-weeks old.

Mellow Bumps
Mellow Bumps is underpinned by attachment theory and aims to encourage nurturing, engagement and synchronicity between mother and baby. Focusing on maternal well-being, women are encouraged to confront and modulate their emotional state through self reflection and group support. The women explore barriers to good parenting and are encouraged to identify beneficial sources of support available to them. Neonates’ capacity for early social interaction is highlighted along with its importance to enhance brain development and attachment. The programme consists of seven two-hour antenatal group sessions and one two-hour postnatal group session. In order to encourage a safe, sharing environment for the participants, partners are invited to one session only. The first antenatal session is delivered when women are between 20-30 weeks pregnant, and the postnatal session occurs when infants are 3 months old.

Care As Usual
All women participating in this study will continue to receive their routine antenatal and postnatal care in line with local NHS and social work guidelines.

Previous interventions:
This trial will compare two antenatal parenting interventions with routine care using outcome, process and health economics evaluation.
Enhanced Triple P for Baby
Enhanced Triple P for Baby is a transition to parenthood intervention which aims to provide babies with a healthy start to life, by combining parenting skills training with strategies to enhance individual wellbeing and couple adjustment. It is informed by social learning theory and has evolved from the universally designed Triple P for Baby. The ‘enhanced’ level has been designed to address the specific health and social care needs of vulnerable women and their families. Group sessions focus on encouraging couples to work together to develop the skills needed to maintain a harmonious family. The women’s partners are invited to all of the group sessions. The programme consists of four two-hour antenatal group sessions and up to eight one-hour postnatal sessions which are delivered on a one-to-one basis either in person or by telephone depending on the participant’s self-assessed needs. The first antenatal session is delivered when women are between 20-30 weeks pregnant, and the postnatal sessions are delivered from when infants are 6-weeks old.
Mellow Bumps
Mellow Bumps is underpinned by attachment theory and aims to encourage nurturing, engagement and synchronicity between mother and baby. Focusing on maternal well-being, women are encouraged to confront and modulate their emotional state through self reflection and group support. The women explore barriers to good parenting and are encouraged to identify beneficial sources of support available to them. Neonates’ capacity for early social interaction is highlighted along with its importance to enhance brain development and attachment. The programme consists of seven two-hour antenatal group sessions and one two-hour postnatal group session. In order to encourage a safe, sharing environment for the participants, partners are invited to one session only. The first antenatal session is delivered when women are between 20-30 weeks pregnant, and the postnatal session occurs when infants are 3 months old.
Care As Usual
All women participating in this study will continue to receive their routine antenatal and postnatal care in line with local NHS and social work guidelines.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Current primary outcome measures (as of 09/04/2018):
The primary outcome measures, which will be recorded at the 6 month follow-up, are:
1. Maternal anxiety, depression and outwardly directed irritability will be measured using the Hospital Anxiety and Depression Scale enhanced by the outwardly directed irritability measures of the Adult Wellbeing Scale (HADS+I)
2. Quality of mother-child interaction will be measured using observer-ratings of video-taped interactions using the CARE Index

Previous primary outcome measures:
The primary outcome measures, which will be recorded at the 6 month follow-up, are:
1. Maternal anxiety, depression and outwardly directed irritability will be measured using the Hospital Anxiety and Depression Scale enhanced by the outwardly directed irritability measures of the Adult Wellbeing Scale (HADS+1)
2. Quality of mother-child interaction will be measured using observer-ratings of video-taped interactions using the CARE Index and Mellow Parenting Observation Scale.

Secondary outcome measures

Current secondary outcome measures (as of 09/04/2018):
1. Number of children flagged as ‘at risk’ on the social services risk register, under a child protection plan, taken into local authority care or attending accident and emergency as measured using routinely collected NHS and Social Care Records
2. Child socio-emotional development as measured using the Strengths and Difficulties Questionnaire
3. Comparison of costs and outcomes associated with intervention delivery and routine antenatal care measured using routinely collected (NHS, social care, criminal justice and education) data, the EQ-5D-3L and self-reported patient service use
4. Assessment of programme fidelity; practitioners’ characteristics and motivation; mothers’ engagement; the intervention mechanisms; and contextual factors affecting mother and infant outcomes using self-reported practitioner data, ethnographic observation and semi-structured qualitative interviews
5. Assessment of whether fathers’ involvement or support affects mothers’ engagement with intervention delivery using semi-structured qualitative interviews


Previous secondary outcome measures:
1. Maternal anxiety, depression and outwardly directed irritability at 18 month follow-up measured using the Hospital Anxiety and Depression Scale enhanced by the outwardly directed irritability measures of the Adult Wellbeing Scale (HADS+1).
2. Quality of the mother-child interaction at 18 month follow-up measured using observer-ratings of video-taped interactions using the CARE Index and Mellow Parenting Observation Scale.
3. Parent self-efficacy at 6 and 18 months measured by the Karitane Parenting Confidence Scale
4. Language development at 18 months measured by the Sure Start Language Questionnaire
5. Language development at 30 months measured by the Sure Start Language Questionnaire
6. Socio-emotional development at age 30 months routinely measured using the Strengths and Difficulties Questionnaire (SDQ).
7. Long-term education outcomes measured by routinely collected education records.
8. Number of children flagged as ‘at risk’ on the social services risk register, under a child protection plan, taken into local authority care or attending accident and emergency measured using routinely collected health and social care records.

Overall trial start date

01/12/2013

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Participant inclusion criteria

Current participant inclusion criteria (as of 09/04/2018):
1. Women identified by midwifery, health and social care professionals and third sector organisations as vulnerable during pregnancy using NHS Greater Glasgow and Clyde Health Board’s Special Needs in Pregnancy protocol. Woman will be recruited after their 12th week of pregnancy.
2. Living within NHS Greater Glasgow and Clyde or NHS Ayrshire and Arran, or living within NHS Lanarkshire and receiving obstetric/maternity care from NHS Greater Glasgow and Clyde or NHS Ayrshire and Arran.
3. Women have a basic understanding of written and spoken English
4. Are able to provide informed consent and are able to engage in and complete the assessments and intervention process.
5. Women must be over 16 years of age to take part (or 14 years with social work support). There is no upper age limit as the study includes all women who are of child bearing age.

Previous participant inclusion criteria:
1. Women identified by midwifery, health and social care professionals and third sector organisations as vulnerable during pregnancy using NHS Greater Glasgow and Clyde Health Board’s Special Needs in Pregnancy protocol. Woman will be recruited after their 12th week of pregnancy. If they are allocated to Mellow Bumps they must attend at least 50% of the eight group sessions in order to remain a participant in the trial. If they are allocated to Enhanced Triple P for Baby they must attend at least 50% of the antenatal group sessions and at least 50% of the postnatal one-to-one sessions.
2. Women will have a basic understanding of written and spoken English
3. Are able to provide informed consent and are able to engage in and complete the assessments and intervention process.
4. Women must be over 16 years of age to take part. There is no age limit as the study includes all women who are of child bearing age.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

500 women will be recruited to the trial. Follow-up data are required from 288 participants to achieve 80% power for both primary outcomes (121 participants in both the Enhanced Triple P for Baby and Mellow Bumps groups and 48 in the Care As Usual group).

Participant exclusion criteria

Current participant exclusion criteria (as of 09/04/2018):
1. Women with poor or no comprehension of spoken English will be excluded as Enhanced Triple P for Baby and Mellow Bumps are group-based and require spoken communication between group members.
2. Women who have passed 30 weeks of pregnancy prior to referral are excluded, as this does not allow sufficient time to complete antenatal sessions.
3. Women with acute mental illness, including active psychosis, are also excluded as their mental ill-health may not allow them to fully participate or engage in the group programmes.
4. Women who are unable to provide a contact address (e.g. home, friend/relative address or homeless shelter) are also excluded as it may be difficult to retain them in this longitudinal study.
5. Women who are involved in a child protection order are assessed on a case-by-case basis in consultation with the professional who referred them and their midwife (if not the referrer) to determine whether they would be appropriate to take part in the study.
6. Women who are participating in another trial of antenatal interventions are excluded to avoid any bias in results.

Previous participant exclusion criteria:
1. Women with poor or no comprehension of spoken English will be excluded as Enhanced Triple P for Baby and Mellow Bumps are group-based and require spoken communication between group members.
2. Women with active psychosis will also be excluded as their mental ill-health may not allow them to fully participate or engage in the group programmes.
3. Women who are unable to provide a contact address (e.g. home, friend/relative address or homeless shelter) will also be excluded as it may be difficult to retain them in this longitudinal study.
4. Women who are involved in a child protection order will be assessed on a case-by-case basis in consultation with the professional who referred them and their midwife (if not the referrer) to determine whether they would be appropriate to take part in the study.

Recruitment start date

01/12/2013

Recruitment end date

31/05/2018

Countries of recruitment

United Kingdom

Trial participating centre

MRC/CSO Social and Public Health Sciences Unit
Glasgow
G2 3QB
United Kingdom

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

c/o Ms Joanne McGarry
Research and Development Management Office
Tennent Institute
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Public Health Research Programme (Ref: NIHR/PR/11/3002/01).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Chief Scientist Office at the Scottish Government (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS Greater Glasgow and Clyde Health Board (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ayrshire and Arran Health Board (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Planned publications of primary and secondary study results in high-impact peer-reviewed journals including open access journal and the HTA series.
Key findings will be communicated in layman’s terms on the Thrive website.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2019 realist process evaluation protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31196169 (added 17/06/2019)
2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31412902 (added 16/08/2019)

Publication citations

• ISRCTN21656568_PIS_v3_02May18.pdf Uploaded 02/05/2018

16/08/2019: Publication reference added. 17/06/2019: Publication reference added. 02/05/2018: Publication and dissemination plan, intention to publish date and participant level data were added, and participant information sheet was uploaded. 09/04/2018: The following changes were made: 1. Recruitment end date was changed from 31/01/2018 to 31/05/2018. 2. Overall trial end date was changed from 31/01/2018 to 31/07/2019. 3. Study contact address and telephone number, primary outcome measures, secondary outcome measures, participant inclusion criteria, participant exclusion criteria, trial participating centre address and interventions were updated. 4. Orcid ID and protocol number were added. 5. Participant inclusion criteria: target number of participants was changed from '500 women will be recruited to the trial. Power calculations demonstrate that 377 (157 participants in both the Enhanced Triple P for Baby and Mellow Bumps groups and 63 in the Care As Usual group)' to '500 women will be recruited to the trial. Follow-up data are required from 288 participants to achieve 80% power for both primary outcomes (121 participants in both the Enhanced Triple P for Baby and Mellow Bumps groups and 48 in the Care As Usual group). 5. Plain English Summary was updated to reflect these changes.