Condition category
Mental and Behavioural Disorders
Date applied
30/08/2016
Date assigned
31/08/2016
Last edited
26/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Depending on how the problem is defined, between 5-20% of all Swedish children grow up with parents who have alcohol problems, which may affect the children negatively. Nine out of ten Swedish municipalities therefore provide resources for support, but less than 2% of these children are reached by this support. Delivering support programs via the internet is a promising strategy. However, web-based programs targeting this at-risk group of children are scarce. Previously, the study team developed a 1.5 hour long web-based self-help program (Alcohol & Coping) which appears to be an effective way to control the adolescent’s own alcohol consumption. However, there is a need for a more intense program, and therefore Kopstoring, a comprehensive Dutch psycho-educative (education for people with mental health problems) prevention program, has been adapted to fit the Swedish context. The purpose of the program, in Swedish called Grubbel, is to strengthen protective factors, such as coping skills and mental well-being, prevent the development of mental health disorders, and to reduce alcohol consumption. The aim of this study is to evaluate the effectiveness of Grubbel, at improving coping strategies, mental health status and substance use.

Who can participate?
15-25 year olds who have at least one parent with a substance use problem and/or mental illness.

What does the study involve?
Participants are randomly allocated to one of two study groups. Those in the first group take part in Grubbel. This involves eight weekly online chat meetings lasting for 1.5 hours each, with a final follow up meeting in the ninth week. Each session fosuses on different themes: (1) getting acquainted with the home situation, (2) roles in the family, (3) thoughts and feelings, (4) questions and answers about mental health problems, risky alcohol use, addiction, and heredity, (5) different behaviour patterns, (6) social networks, (7) leading your own life with regards to social networks, and (8) the future. Between each session, participants complete a homework assignment which is discussed in the following session. Each session is moderated by two trained professionals who have experience working with young people. Those in the second group continue as normal for the duration of the study. At the start of the study and then after 6, 12 and 24 months, participants in both groups complete a number of questionnaires in order to assess their mental health status, alcohol consumption and life satisfaction.

What are the possible benefits and risks of participating?
Participants who receive Grubbel may benefit from improved coping skills and mental wellbeing, which could help prevent them from developing mental health conditions or drinking too much alcohol. There are no notable risks involved with participating in the study.

Where is the study run from?
The study is run from STAD, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services and takes place online (Sweden)

When is study starting and how long is it expected to run for?
April 2016 to December 2018

Who is funding the study?
National Public Health Agency of Sweden (Sweden)

Who is the main contact?
Dr Tobias Elgán
tobias.elgan@ki.se

Trial website

http://www.grubbel.nu

Contact information

Type

Public

Primary contact

Dr Tobias Elgán

ORCID ID

http://orcid.org/0000-0001-6406-4685

Contact details

STAD (Stockholm for the prevention of alcohol and drug abuse)
Centre for Psychiatry Research
Department of Clinical Neuroscience
Karolinska Institutet & Stockholm Health Care Services
Stockholm City Council
Norra Stationsgatan 69
Stockholm
113 64
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1155/2014-6.2

Study information

Scientific title

A web-based group course intervention for 15-25 year olds having parents with substance use problems or mental illness: a randomized controlled trial to measure the effects with regards to mental health, coping skills, quality of life, and own alcohol consumption

Acronym

Grubbel

Study hypothesis

In comparison to a control group who receives care as usual, participants in the intervention group will show improved coping skills, reduced symptoms of depression and behavioural problems, improved quality of life, and a reduction in alcohol consumption.

Ethics approval

Regional Ethical Review Board in Stockholm, 17/09/2015, ref: 2015/1320-31/5

Study design

Multi-centre two-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

Available in Swedish at http://grubbel.nu/content/tack-för-visat-intresse

Condition

Adolescents with at least one parent with a substance use problem and/or mental illness

Intervention

Participants are randomly allocated into the intervention Grubbel or a control group using an unequal allocation ratio of 1:8. An unrestricted random allocation sequence will be used.

Intervention group: The intervention program Grubbel is a manual-based and well-structured prevention program and consists of eight consecutive weekly online chat-meetings, each meeting lasting 1.5 hours, and a ninth follow-up meeting one week after the last meeting. Each session focus on a particular theme:
1. Getting acquainted with the home situation
2. Roles in the family
3. Thoughts and feelings,
4. Questions and answers about mental health problems, risky alcohol use, addiction, and heredity
5. Different behaviour patterns
6. Social network
7. Leading your own life with regards to social networks
8. The future.
The ninth session is a follow-up session. In between each session, the participants are required to complete a homework assignment that is discussed at the following session. Each meeting is moderated by one or two trained professionals (prevention and social workers, and psychologists from mental health and addiction centres) who have previous experience from working with the target group, and has participated in a two-day Grubbel-course held by our research group.

Control group: Participants receive care as usual for the duration of the study, which involves receiving information about where to find care as usual.

All assessment are conducted using web-based questionnaires reached by hyperlinks sent out to the participants via e-mail. The assessment consists of a baseline measurement (T0) which takes place before randomization and three follow-up measurements after 6 (T1), 12 (T2), and 24 (T3) months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Depressive symptoms during the past week are measured using the Center for Epidemiological Studies Depression Scale for children (CES-DC) at baseline, 6, 12 and 24 months
2. Coping strategies are measured using the Brief COPE at baseline, 6, 12 and 24 months
3. Quality of life is measured using the World Health Organization’s Quality of Life Questionnaire (WHOQOL-BREF) at baseline, 6, 12 and 24 months
4. Alcohol consumption is assessed using the short version of the Alcohol Use Disorders Identification Test (AUDIT-C) at baseline, 6, 12 and 24 months

Secondary outcome measures

1. Overall life satisfaction is measured using the Ladder of Life, asking about the participants’ past, present, and future rating of his/her life over a one year perspective at baseline, 6, 12 and 24 months
2. Competencies and behavioural problems are measured using the young person’s version of the Youth Self Report List (YSR), which consists of 119 problem behaviour items that form internalizing and externalizing scales at baseline, 6, 12 and 24 months

Overall trial start date

14/04/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adolescents being 15-25 years old
2. Percieve at least one parent to have a substance use problem and/or mental illness
3. Having access to a computer/tablet/mobile phone and the Internet
4. Fluent in Swedish
5. Being able to participate on a weekly basis
6. Provide an e-mail address
7. Having consented to participate

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. No easy access to computer and the internet
2. Not sufficiently fluent in Swedish
3. Symptoms of severe depression
4. Suicidal or self-inflicted harm behaviour

Recruitment start date

14/04/2016

Recruitment end date

30/06/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

STAD (Stockholm for the prevention of alcohol and drug abuse)
Centre for Psychiatry Research Department of Clinical Neuroscience Karolinska Institutet & Stockholm Health Care Services Stockholm County Council Norra Stationsgatan 69
Stockholm
113 64
Sweden

Sponsor information

Organisation

STAD (Stockholm for the prevention of alcohol and drug abuse)

Sponsor details

Centre for Psychiatry Research
Department of Clinical Neuroscience
Karolinska Institutet & Stockholm Health Care Services
Norra Stationsgatan 69
Stockholm
11364
Sweden

Sponsor type

University/education

Website

www.stad.org

Funders

Funder type

Government

Funder name

National Public Health Agency of Sweden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publications are planned in high-impact peer reviewed journals around one year after the second and third follow-up.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27663995

Publication citations

Additional files

Editorial Notes

26/09/2016: Publication reference added.