Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fionnuala Larkin
ORCID ID
Contact details
Department of Psychology
University of York
Heslington
York
YO10 5DD
United Kingdom
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fionnuala.larkin@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16561
Study information
Scientific title
Assessing the efficacy of an intervention to improve mind-mindedness in teenage mothers: a randomised controlled trial
Acronym
Mind-mindedness Intervention
Study hypothesis
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
14/NE/0114; First MREC approval date 22/05/2014
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
17/02/2014
Overall trial end date
30/06/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged below 20
2. Pregnant or the mother of a baby younger than 6 months of age
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 210; UK Sample Size: 210
Participant exclusion criteria
Mothers who are not native English speakers
Recruitment start date
29/07/2014
Recruitment end date
30/06/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychology
York
YO10 5DD
United Kingdom
Funders
Funder type
Research council
Funder name
Economic and Social Research Council (ESRC); grant codes: ES/K010719/1
Alternative name(s)
ESRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
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
Intention to publish date
31/03/2018
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary