Condition category
Mental and Behavioural Disorders
Date applied
22/05/2018
Date assigned
23/05/2018
Last edited
23/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.kcl.ac.uk/index.aspx

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

Publication citations

Additional files

Editorial Notes