A parallel group cluster randomized controlled trial where communities will be randomly assigned, with concealed allocation, to one of two groups, with a 1:1 allocation ratio. Communities in the intervention arm will participate in SFP10-14 group sessions; communities in the control arm of the trial will receive information leaflets for families. All families recruited into the trial will be assessed at baseline and at 12 and 24 months follow-up. Two years after baseline data collection, families from control communities will be offered the opportunity to participate in SFP10-14.
Research undertaken in Poland funded by the National Bureau for Drug Prevention is reviewed by independent experts, and this independent review process covers scientific and any ethical issues that are identified by the independent reviewers. Ethics Committee approval for data collection was obtained from “Komisji Bioetycznej przy Instytut Psychiatrii I Neurologii W Warszawa” (Ethics Committee of the Warsaw Institute for Psychiatry and Neurology). Each family recruited into the trial receives an information sheet describing the trial and data collection procedures before giving their written and signed consent to participate. Consent was obtained from parent(s) and, separately, from children.
Setting and participants
Eligible participants are families with 10–14 year-old children from community settings across Poland. In all families at least one parent should agree to participate. If two children from the same family are involved in the intervention group then both parents will be asked to participate in SFP10-14 group sessions.
Communities who have expressed an interest in the SFP10-14 will be approached in 2010 to participate in the trial. Information about the SFP10-14 has been disseminated throughout Poland via conferences, journal articles, information bulletins and personal contact. Within communities, families will be recruited by community workers. Family recruitment will take place through community agencies, schools and via information leaflets and personal contact.
Randomization occurs after communities have consented to participate in the trial. Simple randomization of community to intervention or control arm will be undertaken by the lead investigator drawing names out of a hat in a concealed allocation format.
The SFP10–14 is a video based programme delivered by trained facilitators that includes parents/guardians and children learning together [26–29]. The 7-week program is delivered over 7-sessions, with 4 optional booster sessions available several months later. The weekly sessions last two to three hours: in the first hour parallel groups of children and parents from up to 15 families develop their understanding and skills, led by parent and child group facilitators; in the second hour, parents and children come together in family units to practice the principles they have learned. The remaining time is spent in logistics, meals and enjoyable family activities. The programme is highly structured with detailed manuals, videos and activities whilst at the same time being highly interactive [26–29].
Alongside demographic questions (including family size and structure, parental education, work status, disposable income) we have carefully selected validated instrument measures/scales:
Alcohol, cigarette and other drugs: age of first use, lifetime prevalence, 30-days (not other drugs) and 12-month prevalence
Alcohol use without parent permission
Drunkenness/binge drinking in past 30 days
General Child Management [30–32]
Parent – Child Affective Quality [30, 32]
Aggressive and Hostile Behaviors in Interactions [30, 32]
Intervention-targeted Parenting Behavior scale [32, 33]
Index of Aggressive and Destructive Conduct [34, 35]
Family aggressiveness 
Family togetherness 
Maternal support 
Parental monitoring 
Time spent with Mother/Father 
Family Life Questionnaire 
School behavior grades
Grade Point Average
Strengths and Difficulties Questionnaire [38, 39]
Parental alcohol and cigarette use
Data are collected at baseline, 12 and 24 months. Interview-based questionnaires will be completed by parents and independently by children in separate rooms. In the control group one parent (or both if they express an interest) will complete the questionnaire, and if there are two children in the target age range (10–14) only the youngest will be asked to complete the questionnaire.
Due to the nature of the intervention blinding of participants, SFP10-14 facilitators and data collectors is not possible.
Sample size calculation
No formal sample size calculation was undertaken but funding was requested for a sample size (N = 600 families) which was similar to that reported in other trials of the SFP10-14 [12–16]. These other trials have reported SFP10-14 effectiveness for reducing a number of risky behaviours amongst young people, including alcohol and drug use and misuse and other behavioural problems.
Clustering at the community and family level will be taken account of in multi-level data analysis. Statistical tests of difference in proportions or mean difference tests (or non-parametric equivalents) will be used to examine differences between intervention and control groups. Based on pilot study results , data will be analyzed for the whole sample and by several sub-group analyses: child age group (10–12; 13–14); family problems (violence, chronic illness, substance use problems, financial problems etc.; low vs high severity); child behaviour and emotional problems (low vs high severity). All analyses will be on an intent-to-treat basis, and both completed case analysis and multiple imputation analysis will be undertaken.