Plain English Summary
Background and study aims
Autobiographical memory shapes our self-identity, self-esteem and wellbeing. Conversely, ‘memory biases’, the tendency to retrieve negative over positive memories from the past and future, and ‘over-general memories’, the difficulty recalling memories of specific events, are linked with poor mental health. As these memory styles increase risk for later mental health difficulties, they could be a potential target for interventions promoting wellbeing. The aim of this study is to investigate whether a storybook intervention co-produced by research and clinical scientists, a children’s artist, and children aged 6-9 years old (and their parents), can teach children (and their parents/guardians) more ‘helpful’ memory styles.
Who can participate?
Children aged 6-9 years
What does the study involve?
Participants are randomly allocated to one of two groups, who receive either the intervention or control storybook. Both storybooks contain the same pictures and format and consist of a story, rationale and six exercises to be completed over a period of 3 weeks. Through a story about a central character, the intervention storybook includes information on how maladaptive responses to negative memories (such as avoidance) are unhelpful and suggests alternative positive responses (such as building detailed memories). It also provides information on building detailed positive future images. The text of the control storybook differs so that content on memory processes is not included. Feedback is solicited from children and parents/guardians.
What are the possible benefits and risks of participating?
It is not yet certain whether taking part will be of benefit to participants, but they will help to work out how best to support children, parents and teachers. There are no known risks for taking part in this study, but it is possible that talking about events in the past may make a child feel sad, and there will always be someone available for them to talk to and who can help.
Where is the study run from?
King's College London (UK)
When is the study starting and how long is it expected to run for?
June 2017 to December 2020
Who is funding the study?
British Academy (UK)
Who is the main contact?
Dr Victoria Pile
victoria.pile@kcl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Victoria Pile
ORCID ID
http://orcid.org/0000-0002-9177-2844
Contact details
Department of Psychology
Institute of Psychiatry
Psychology and Neuroscience
King's College London
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0389
victoria.pile@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Improving cognitive health and wellbeing in children: increasing the specificity of future positive memories and past negative memories using storybook narratives and character illustrations
Acronym
Study hypothesis
The aim of this study is to investigate the acceptability, feasibility and preliminary effectiveness of a storybook intervention targetting memory processes in children.
Ethics approval
Psychiatry, Nursing and Midwifery Research Ethics Subcommittee of the College Research Ethics Committee (CREC) at King's College London, 23/05/2018, ref: HR-16/17-4115
Study design
Interventional feasibility randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Depression and anxiety
Intervention
Children will be randomly allocated to receive the storybook ("My Memory Forest") or control intervention. Both will contain the same pictures and format. Both the storybooks will consist of a story, rationale and 6 exercises to be completed over a period of three weeks. Through a story about a central character, "My Memory Forest" includes information on how maladaptive responses to negative memories (such as avoidance) are unhelpful and suggests alternative positive responses (such as building detailed memories). It also provides information on building detailed positive future images. The text of the control book will differ so that content on memory processes is not included.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Feasibility and acceptability of the intervention are assessed by recording numbers of eligible participants, recruitment rate, retention rate, outcome measure completion rate, data completeness, data on adherence/compliance, and feedback questionnaires
Secondary outcome measures
All measures are administered pre and post intervention unless otherwise stated
Child measures:
1. Depression is measured using the Center for Epidemiological Studies-Depression (CES-D)
2. Anxiety is measured using the social anxiety, generalised anxiety and separation anxiety subscales on the Spence Children's Anxiety Scale (SCAS)
3. Self-esteem is measured using the Rosenberg self-esteem scale
4. Memory specificity is measured using the Autobiographical Memory Task pre and post-intervention
5. Mental imagery for future events is measured using the Prospective Imagery Task
6. Participants will be asked to complete positive and negative mood ratings before and after completing each exercise
Parent report:
1. Internalising symptoms (for the child) will be measured using the subscales of the Strengths and Difficulties Questionnaire (SDQ)
2. Depression is measured using the Patient Health Questionnaire (PHQ-9)
3. Anxiety is measured using the Generalised Anxiety Disorder Assessment (GAD-7)
4. Mental imagery for future events is measured using the Prospective Imagery Task
Overall trial start date
30/06/2017
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children aged 6-9 years
Participant type
All
Age group
Child
Gender
Both
Target number of participants
56
Participant exclusion criteria
1. Child/caregiver has insufficient English language ability to complete the questionnaire measures and intervention
2. Child has severe learning disability or sensory impairment
Recruitment start date
30/05/2018
Recruitment end date
05/06/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
Institute of Psychiatry, Psychology and Neuroscience
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
Guy’s Campus
London
SE1 4UL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
British Academy
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Planned publication of outcomes to peer-reviewed journal within a year from end of trial
2. Dissemination via conferences and to schools/NHS services at a local level
3. Protocol will be available on request
IPD sharing statement
It is planned to make individual participant data available on publication of the associated study results, via a publicly-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.
Intention to publish date
31/12/2021
Participant level data
Stored in repository
Basic results (scientific)
Publication list