Condition category
Not Applicable
Date applied
05/03/2011
Date assigned
17/03/2011
Last edited
12/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katarzyna Okulicz-Kozaryn

ORCID ID

Contact details

Institute of Psychiatry and Neurology
Sobieskiego 9
Warsaw
02-957
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of the Strengthening Families Program (SFP10-14) for reducing alcohol and drug misuse amongst youth in Poland: a randomised controlled trial

Acronym

Study hypothesis

1. SFP10-14 will reduce alcohol and drug use / misuse amongst young people compared with controls
2. SFP10-14 will reduce behavioural and emotional problems amongst young people compared with controls
3. SFP10-14 will improve parenting compared with controls
4. SFP10-14 will improve parent-child relations compared with control

Ethics approval

There is no formal ethics committee requirement for research projects funded by the Polish Bureau for Drug Prevention (the research funders), though there is an expectation in cases that any ethical issues are identified during the scientific peer review process organised by the funding agency.

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Public Health

Intervention

The SFP10–14 is a video based programme delivered by trained facilitators that includes parents/guardians and children learning together. The 7-week program is delivered over 7-sessions, with four optional booster sessions available several months later.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Alcohol, cigarette and other drugs: age of first use, lifetime prevalence, 30-days (not other drugs) and 12-month prevalence
2. Alcohol use without parent permission
3. Drunkenness / binge drinking in past 30 days

Secondary outcome measures

1. General child management
2. Parent – child affective quality
3. Aggressive and hostile behaviours in interactions
4. Intervention-targeted parenting behaviour scale
5. Index of aggressive and destructive conduct
6. Family aggressiveness
7. Family togetherness
8. Maternal support
9. Parental monitoring
10.Time spent with mother / father
11. Family rituals
12. Family life questionnaire
13. Truancy
14. School behaviour grades
15. Strengths and difficulties questionnaire

Overall trial start date

04/01/2010

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Families with one or more children aged 10-14
2. At least one parent and one child consents to participate

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

600

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

04/01/2010

Recruitment end date

31/03/2013

Locations

Countries of recruitment

Poland

Trial participating centre

Institute of Psychiatry and Neurology
Warsaw
02-957
Poland

Sponsor information

Organisation

Institute of Psychiatry and Neurology (Poland)

Sponsor details

Sobieskiego 9
Warsaw
02-957
Poland

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Polish Bureau for Drug Prevention (Poland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diageo PLC

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

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22551472

Publication citations

  1. Protocol

    Okulicz-Kozaryn K, Foxcroft DR, Effectiveness of the Strengthening Families Programme 10-14 in Poland for the prevention of alcohol and drug misuse: protocol for a randomized controlled trial., BMC Public Health, 2012, 12, 319, doi: 10.1186/1471-2458-12-319.

Additional files

Editorial Notes