Condition category
Mental and Behavioural Disorders
Date applied
05/12/2011
Date assigned
19/12/2011
Last edited
30/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It has been estimated that approximately 20% of all Swedish children grow up with parents having alcohol problems, which may result in negative outcomes in these children. Hence, most Swedish municipalities provide resources for support, but at the same time figures show that not even 2% receive support, mainly due to difficulties in identifying and recruiting these children into support programs. Delivering intervention programs to children and adolescents via the Internet seems a promising strategy, but to date, the number of web-based interventions aimed at this target group is very scarce. We have therefore developed a novel internet-delivered therapist assisted self-help intervention called the web-ICAIP (Individual Coping and Alcohol Intervention Program) for adolescents having parents with alcohol problems.
The purpose of the web-ICAIP, which solely takes place on the Internet, is to strengthen adolescents’ coping behaviour, improve their mental health, and postpone the onset or decrease risky alcohol consumption. The program consists of film-based lectures and stories, various exercises, and personalized feedback.

Who can participate?
The study is open to Swedish-speaking adolescents between 15 and 19 years old who have at least one parent with alcohol problems.

What does the study involve?
Participants will be randomly allocated to an intervention group, with access to the web-ICAIP, or to a waiting list control group, representing treatment as usual. The study will run for six months and assessment consists of online self-administered questionnaires that are to be filled in by the participants at baseline and at two follow-ups (after two and six months following the baseline).

What are the possible benefits and risks of participating?
There may be times where some participants feel discomfort as they are asked to reflect over their own situation. However, it is stressed that the study is anonymous and strictly voluntary, and participants can choose to terminate their involvement at any time. Furthermore, having in mind the overall aim of the web-ICAIP, participation may result in possible benefits such as improved mental health and coping behaviour, and participants may also postpone their onset of alcohol consumption or decrease their risky alcohol use.

Where is the study run from?
Recruitment will mainly take place at the Drugsmart website (www.drugsmart.com)

When is the study starting and how long is it expected to run for?
January to July 2012.

Who is funding the study?
The study has been funded by grants from the Swedish National Institute of Public Health and the Swedish Council for Working Life and Social Research.

Who is the main contact?
Tobias Elgán at STAD, Stockholm Centre for Psychiatric Research and Education (Sweden).

Trial website

Contact information

Type

Scientific

Primary contact

Dr Håkan Leifman

ORCID ID

Contact details

STAD
Stockholm Centre for Psychiatric Research and Education
Stockholm County Council Health Care Provision and Karolinska Institutet
Box 6031
Stockholm
102 31
Sweden
hakan.leifman@sll.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of a web-based Individual Coping and Alcohol-Intervention Program (web-ICAIP) for children of parents with alcohol problems: A randomized controlled trial

Acronym

Web-ICAIP

Study hypothesis

The intervention group, who have access to the web-ICAIP, in comparison to the control group, representing treatment as usual, will:
1. Improve their coping behavior
2. Improve their mental health
3. Postpone the onset of alcohol consumption or decrease their risky alcohol consumption

Ethics approval

Regional Ethical Review Board, Karolinska Institute, 1 December 2011, ref: 2011/1648-31/5)

Study design

Single centre parallel-group single-blinded randomised controlled intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Adolescents having at least one parent with alcohol problems

Intervention

The trial includes two arms. The first one is the waiting list control group, representing treatment as usual, which may include participating in a "face-to-face" support group or being active at self-help forums. The other group is the intervention group which has access to the web-ICAIP which is "locked" during the study period.

The web-ICAIP is derived from the manual-based "face-to-face" Individual Coping and Alcohol Intervention Program (ICAIP). Similar to the original ICAIP intervention, the web-ICAIP is divided into an alcohol and a coping theme, consisting of:
1. Three film-based lectures (each between 8-15 min) concerning alcohol problems within the family
2. One optional film-based lecture related to risky alcohol consumption
3. Four stories, so called readers' letters, which relates to coping and alcohol problems within the family
4. Various exercises related to alcohol and coping behavior
5. Automatic personalized feedback messages
6. Personalized feedback from experts
7. Participants formulate their own action plan for the future

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Study assessment take place at baseline and at 2 and 6 months following baseline.
1. Depressive symptoms will be measured using the Center for Epidemiological Studies Depression Scale (CES-DC) (four-point likert scales) where a higher total score indicate more depressive symptoms
2. Coping behavior will be measured using a Coping Behavior Scale for children of alcoholics (four-point likert scales)
3. Alcohol consumption will be measured using the short version of the Alcohol Use Disorders identification Test (AUDIT-C)
4. Questions will be asked related to whether or not the respondents have ever consumed alcohol to the point that he/she felt intoxicated, and respondents’ age of onset of drinking and intoxication

Secondary outcome measures

1. Program adherence will be measured in terms of completed film-based lectures and exercises
2. Overall life satisfaction will be measured by asking about the participants’ past, present, and future rating of his/her life on a ten-point “Ladder of life” representing life status from “worst” to “best” possible life imaginable

Overall trial start date

02/01/2012

Overall trial end date

01/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adolescents being 15-19 years old
2. Have at least one alcoholic parent
3. Approved of informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

184

Participant exclusion criteria

1. No easy access to computer and the Internet
2. Not sufficiently fluent in Swedish
3. Suicidal or self inflicted harm behavior

Recruitment start date

02/01/2012

Recruitment end date

01/07/2012

Locations

Countries of recruitment

Sweden

Trial participating centre

STAD
Stockholm
102 31
Sweden

Sponsor information

Organisation

Stockholm Prevents Alcohol and Drug Problems (STAD) (Sweden)

Sponsor details

Stockholm Centre for Psychiatric Research and Education
Stockholm County Council Health Care Provision and Karolinska Insitutet
Stockholm
102 31
Sweden
stad.slso@sll.se

Sponsor type

Government

Website

http://www.stad.org/en/

Funders

Funder type

Government

Funder name

Swedish National Institute of Public Health (Sweden) ref: HFÅ 2009/133

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Council for Working Life and Social Research (Sweden) ref: 2009-1705

Alternative name(s)

Swedish Council for Working Life and Social Research, FAS

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Sweden

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

1. 2012 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22248564

Publication citations

  1. Study protocol

    Elgán TH, Hansson H, Zetterlind U, Kartengren N, Leifman H, Design of a Web-based individual coping and alcohol-intervention program (web-ICAIP) for children of parents with alcohol problems: study protocol for a randomized controlled trial., BMC Public Health, 2012, 12, 35, doi: 10.1186/1471-2458-12-35.

Additional files

Editorial Notes