Condition category
Mental and Behavioural Disorders
Date applied
28/06/2013
Date assigned
28/06/2013
Last edited
30/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There are many pressures on young people today, and life can be very stressful at times. When stress increases, it can affect how young people feel. Stress might make young people feel moody or really low. Depression is now common among young people. Those whose parents suffer from depression are at greater risk of developing depression themselves, compared to young people whose parents don't suffer from depression. Against this background, our research project has two main aims.
First, we want find out how many young people whose parents suffer from depression have some mild symptoms of stress and depression themselves. The symptoms young people might have are things like feeling irritable or sad, not enjoying things, and having trouble sleeping, concentrating, or eating.
Second, for young people who report such symptoms, we want to find out if a new course, called 'Coping with Stress', can help prevent symptoms of stress and depression from getting worse. Many young people in America have benefited from this course, but it has never been used in England before.

Who can participate?
The research is in two stages. In the first stage, we are inviting parents who have suffered from depression in the past or currently, and have a son or daughter aged between 10 and 17 years old, to take part. If you choose to take part, then we will invite your son or daughter to also take part in Stage 1 (unless they have trouble reading English). In the second stage, we will invite young people whose scores on a questionnaire show that they are suffering from mild symptoms of stress and low mood to take part.

What does the study involve?
In stage 1, your child will be asked to fill in a questionnaire. The questionnaire takes a few minutes to fill out. It is not a test and there are no right or wrong answers. It can be completed online, or by filling in a paper copy. The questionnaire is private. Only the research team will see the answers. After young people have completed the questionnaire, we will ask some parents and young people to talk to one of our research team for about 30-45 minutes. The purpose of this interview is to ask for your views about the project and about filling in this sort of questionnaire. We would like to record this discussion, and would ask your permission to do so. You don't have to talk to the researcher if you don't want to.
In stage 2, if your child is eligible, he or she will be invited to come to the Coping with Stress course. The course is for groups of 8-10 young people. There will be 8 meetings once a week, for about 90 minutes for young people. Afterwards, there will be 6 more meetings once a month, also for about 90 minutes. There will also be three groups for parents. The groups will be led by a clinical psychologist. This would be an opportunity for you to meet other parents in a similar situation as you, and to hear about ways to help young people.
To see how well the Coping with Stress course works, half of the young people who agree to take part will use it immediately while half will use it after a delay of 8 months. Whether young people are invited to come to the Coping with Stress course immediately or after a delay is decided by chance, like flipping a coin. Young people will have a 50:50 chance to do the course immediately.
Before the course, after the 8-week course has finished, and 6 months later, we will ask you and your son or daughter to complete a few questionnaires. This will take about 30 minutes. Additionally, we would like to interview you about your son or daughter's symptoms, and about your relationship, which will take about 90 minutes. We would also like to interview your son or daughter about their symptoms, and about your relationship, which will take about 90 minutes.
After the course, we would like to talk to you, and your son or daughter, to find out what you thought of it. This is to see if we can improve the course for the future. These interviews would take about 20-30 minutes each. We would like to record the interviews, and would ask your permission to do so.

What are the possible benefits and risks of participating?
The main benefit is that the evidence so far shows that young people are likely to be helped by coming to the Coping with Stress course. We hope that young people will benefit by learning to cope better with stress and low moods. It is unlikely that there are any risks. Sometimes, combating stress and low mood is hard work and it can be upsetting for young people and families, but there will always be someone there to help if you or your son or daughter needs it. All the information you tell us is private and confidential. If your son or daughter tells us something that means that they are at risk of harm (for example if someone is threatening them, or if they want to hurt themselves), then we would need to break confidentiality, and let you know. We will offer immediate specialist help if this situation arises.

Where is the study run from?
The TARGET study has been set up by King's College London in collaboration with South London and Maudsley NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in September 2013, and continue until October 2014. The study is expected to run until November 2015.

Who is funding the study?
Funding is provided by the National Institute for Health Research (NIHR; UK), Research for Patient Benefit (RfPB) scheme.

Who is the main contact?
Dr Helen Underwood
Helen.Underwood@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Underwood

ORCID ID

Contact details

Institute of Psychiatry
Department of Psychology (PO77)
16 De Crespigny Park
London
SE5 8AF
United Kingdom
-
helen.underwood@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13173

Study information

Scientific title

Prevention of major depression in at-risk adolescents: a pilot randomised controlled trial of a screen-and-intervene program

Acronym

TARGET

Study hypothesis

The objective of the research is to conduct a pilot trial to assess the acceptability, feasibility, and preliminary clinical effectiveness of a targeted screen-and-intervene CBT program to prevent depression in at-risk young people.

Principal research question:
At Stage 1: Is screening of offspring of parents with a history of depression acceptable to young people and their parents; and is screening feasible to carry out? (This part of the research is exploratory and there are no hypotheses to be tested.)

At Stage 2: Is a group Cognitive Behavioural Therapy (CBT) prevention program acceptable to young people, feasible to implement, and clinically effective?

Hypotheses:
1. Participants randomly allocated to CBT will show a lower incidence of depression diagnosis at post-intervention and at 6-month follow-up, compared to those allocated to Usual Care.
2. Participants randomly allocated to CBT will show less severe symptoms of depression on continuous measures of depression at post-intervention and 6-month follow-up, compared to those allocated to Usual Care.
3. Response to intervention will be moderated by parental depression severity, family atmosphere and communication, and participant cognitive style.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13173

Ethics approval

NRES Committee South East Coast - Kent, 24/12/2012, ref: 12/LO/1475

Study design

Single-centre interventional randomised single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression

Intervention

Randomised controlled trial comparing Coping with Stress group to Usual Care control. Randomisation stratifying for age, gender, initial symptom severity and parental depression severity.

Group CBT depression prevention program, called Coping with Stress, will be compared with "usual care" control group. The Coping with Stress group consists of weekly group sessions delivered over 8 weeks, followed by monthly sessions once per month for 6 months. Each session will last 90 minutes.

The control group will receive usual care during the study period, and will be invited to take part in the Coping with Stress group after a delay of 8 months.

Follow-up assessment to take place immediately after the 8-week group and at 6-month follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

LIFE Interview; Timepoint(s): Post CBT group and at 6-month follow-up

Secondary outcome measures

1. Children's Depression Rating Scale (CDRS); Timepoint(s): The CDRS is to be administered pre and post group, and at 6-month follow-up
2. Moods and Feelings Questionnaire (MFQ); Timepoint(s): The MFQ is to be administered pre and post group, and at 6-month follow-up.
3. Screen for Anxiety and Related Disorders in Childhood (SCARED-C); Timepoint(s): The scared will be administered pre and post group, and at 6-month follow-up.
4. Strengths and Difficulties Questionnaire (SDQ); Timepoint(s): The SDQ will be administered pre and post group, and at 6-month follow-up.

Overall trial start date

12/08/2013

Overall trial end date

30/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Stage 1:
Adults:
1. Current or past diagnosis of an affective disorder (i.e. a major depressive episode in the last 3 years OR >= 3 major depressive episodes or >= 3 cumulative years in a major depressive or dysthymic episode in the young person's lifetime)
2. Have a son or daughter between 10-17 years old
Young people:
1. Aged between 10-17 years old
2. Able to read English

Stage 2:
1. Young people: aged between 10-17 years old
2. Able to read English
3. MFQ score 20-29 or previous diagnosis of Major Depressive Disorder

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 250; UK Sample Size: 250; Description: Stage 1 190 parent offspring pairs.Stage 2 RCT 60 high risk young people

Participant exclusion criteria

Stage 1:
Adults: past or current diagnosis of bipolar affective disorder or schizoaffective disorder

Stage 2:
Young people: Current diagnosis of major depressive disorder (determined by clinical interview KSADS); another primary disorder in need of treatment

Recruitment start date

01/09/2013

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute Of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom
-
Jennifer.Liebscher@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Government

Funder name

NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-021124152

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes