Assessing the efficacy of an intervention to improve mind-mindedness in teenage mothers
| ISRCTN | ISRCTN19383681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19383681 |
| Secondary identifying numbers | 16561 |
- Submission date
- 26/09/2014
- Registration date
- 26/09/2014
- Last edited
- 22/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Findings from a number of studies show that parents' ability to 'tune in' to what their baby might be thinking or feeling (so-called 'mind-mindedness') is important for secure attachment, language, play and understanding of other people's thoughts and feelings. For families in poverty, parents' ability to tune in to their babies' thoughts and feelings helps the child avoid developing problem behaviours at school-starting age. This research shows the widespread benefits of parents' willingness to see things from the child's perspective. The main aim of this project is to develop and evaluate an intervention package that will use a smartphone app to inform parents in an accessible way about mind-mindedness. The effectiveness of this intervention package will be evaluated by looking at its impact on mother-baby interaction and child outcome in teenage mothers.
Who can participate?
Pregnant women or mothers aged under 20 with babies who are 6 months old or younger.
What does the study involve?
Participants will be randomly allocated to receive either the intervention package or a control package. The intervention package consists of an animated film and booklet to inform mothers about mind-mindedness, and a mind-mindedness smartphone app that has been designed for the study. The control group will receive a film and booklet focussed on general development and a widely-available baby app. Mothers and their 6-month-old babies will meet with the researchers. Mothers will be filmed playing with their babies for 20 minutes and will fill in some questionnaires about their background and wellbeing. The researcher will then show them a film, provide a booklet, and show them how the smartphone app works. The app will be downloaded onto the mothers phone for her to keep. Altogether, this will last about an hour and mothers will be paid for their time and travel. Mothers will use the smartphone app until their babies are 12 months old, when mothers and babies will meet with the researchers again. They will again be filmed playing together and mothers will fill in some questionnaires. The session will last about an hour and mothers will again be paid for their time and travel.
What are the possible benefits and risks of participating?
The app is designed to be fun to use, and will help mothers learn about their babys development in a new, interactive way. Some mothers may find answering the questionnaires uncomfortable, but the researchers will be able to provide support if needed.
Where is the study being run from?
The researchers are based at the University of York and are working with GPs, health visitors and maternity sites across North Yorkshire to identify suitable participants. Testing will normally take place in the University of Yorks baby suite, but can be conducted at a local childrens centre or clinic if that is more convenient for mothers.
When is the study starting and how long is it expected to run for?
The study runs from July 2014 until June 2016.
Who is funding the study?
Economic and Social Research Council (ESRC) (UK).
Who is the main contact?
Dr Fionnuala Larkin
fionnuala.larkin@york.ac.uk
Contact information
Scientific
Department of Psychology
University of York
Heslington
York
YO10 5DD
United Kingdom
| fionnuala.larkin@york.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Assessing the efficacy of an intervention to improve mind-mindedness in teenage mothers: a randomised controlled trial |
| Study acronym | Mind-mindedness Intervention |
| Study objectives | The study seeks to evaluate whether mind-mindedness can be enhanced amongst teenage mothers through the provision of a 6-month, technology-based intervention package involving a smartphone app and animated film. |
| Ethics approval(s) | 14/NE/0114; First MREC approval date 22/05/2014 |
| Health condition(s) or problem(s) studied | Topic: Reproductive Health; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth |
| Intervention | There will be two trial arms: the mind-mindedness intervention and the control intervention. 1. An animated film and associated booklet will inform the intervention group about mind-mindedness, and they will receive a mind-mindedness smartphone app that has been designed for the study. 2. The control group will receive a package focussed on general developmental milestones and a pre-existing baby app that is widely available. |
| Intervention type | Other |
| Primary outcome measure | Mind-mindedness will be assessed from transcripts of parent-child interaction using previously operationalised coding procedures (Meins & Fernyhough, 2012). Timepoint(s): After 6 months of intervention |
| Secondary outcome measures | 1. Maternal mental health; Timepoint(s): After 6 months of intervention 2. Parent-child attachment; Timepoint(s): When child is aged 12 months These will be assessed through administration of the following measures: 1. Slade Pregnancy Interview, Revised (Slade, 2011) 2. Hospital Anxiety and Depression Scales (Zigmond & Snaith, 1983) 3. Rosenberg Self-Esteem Scale (Rosenberg, 1965) 4. Parental Bonding Instrument: Brief Current (PBI-BC; Klimidis, Minis & Ata, 1992) 5. Relationship Questionnaire (Bartholomew & Horowitz, 1991) 6. Family Emotional Involvement and Criticism Scale (perceived criticism items) (FEICS; Shields, Franks, Harp, McDaniel, and Campbell, 1992) 7. Los Angeles Symptom Checklist (LASC; King, King, Leskin, & Foy, 1995) 8. Parenting Stress Index, Short Form (3rd edition). (Abidin, 1995) 9. Recent Life Events Questionnaire (Department of Health, 1985) 10. Interpersonal Reactivity Index (IRI; Davis 1980) 11. Multidimensional Scale of Perceived Social Support (MSPSS; Zimet, Dahlem, Zimet & Farley, 1988) 12. Parenting Sense of Competence Scale (Gibaud-Wallston & Wandersman, 1978) 13. Parent Development Interview Revised Short Version (Slade, Aber, Berger, Bresgi & Kaplan, 2012) 14. Laboratory Temperament Assessment Battery (Goldstein & Rothbart, 1999) 15. Strange Situation (Ainsworth & Wittig, 1969) |
| Overall study start date | 17/02/2014 |
| Completion date | 30/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 210; UK Sample Size: 210 |
| Total final enrolment | 141 |
| Key inclusion criteria | 1. Aged below 20 2. Pregnant or the mother of a baby younger than 6 months of age |
| Key exclusion criteria | Mothers who are not native English speakers |
| Date of first enrolment | 29/07/2014 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
YO10 5DD
United Kingdom
Sponsor information
University/education
Room 152 Seebohm Rowntree Building
York
YO10 5DD
England
United Kingdom
"ROR" |
https://ror.org/04m01e293 |
|---|
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- ESRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publication and dissemination plan as of 30/11/2018: Planned publication in high impact developmental journals. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date Previous publication and dissemination plan: Planned publication in high impact developmental journals. IPD sharing statement: The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository: the ESRC data service provider or the University of York’s data repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/08/2019 | 22/04/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
30/11/2018: The following changes were made:
1. The intention to publish date was changed from 31/01/2019 to 31/05/2019.
2. The publication and dissemination plan was updated.
13/11/2018: The intention to publish date was changed from 31/03/2018 to 31/01/2019.
06/07/2017: Internal review.
15/06/2017: Trial dates changed from 29/07/2014 - 30/06/2016 to 17/02/2014 - 30/06/2018. Added participant level data sharing statement and the publication and dissemination plan. Added the intention to publish date.
