Study Protocol of Effectiveness Evaluation of the Strengthening Families Program in Brazil

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-7q9xh5
• Date of registration: 05/09/2017
• Prospective Registration: No
• Primary sponsor: Instituto de Psicologia da Universidade de Brasília
• Public title: Study Protocol of Effectiveness Evaluation of the Strengthening Families Program in Brazil
• Scientific title: Effectiveness, Implementation Quality and Social Validity Evaluation of the Strengthening Families Program
• Date of first enrolment: 01/08/2017
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-7q9xh5
• Study type: Intervention
• Study design: Parallel, open, two arms, on a family basis non-randomized controlled clinical trial, focusing in Prevention.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Luis Gustavo do Amaral Vinha
• Affiliation: Universidade de Brasília

• Name: Sheila Giardini Murta
• Affiliation: Universidade de Brasília

Key inclusion & exclusion criteria

Inclusion criteria: Families with children between 10 and 14 years of age; concurrent participation of the child/adolescent and at least one parent/guardian; users of public services intended for economically disadvantaged families.
Exclusion criteria: Children/adolescents participating in other evidence-based preventive programs with similar goals; families with rights violations, such as children suffering severe mistreatment; families whose children/adolescents are problematic drug users in need of treatment; and families whose parents are not available to accompany the child/adolescent throughout the intervention.

Age minimum: 10Y
Age maximum: 14Y
Gender: -

Health Condition(s) or Problem(s) studied

Substance-Related Disorders

C25.775

Intervention(s)

Behavioural

Experimental group: 1813 children and adolescents between 10 and 14 years of age, accompanied by their parents or legal guardian, participate in the Strengthening Families Program. Control group: 718 children and adolescents between 10 and 14 years of age, receive only the usual services of the Social Assistance Reference Centers.


Strengthening Families Program is a preventive intervention with families aiming to reduce risk factors for substance use and abuse.

N02.370

Primary Outcome(s)

Primary outcomes: delay of first drug use; reduction in binge drinking and frequency of use of alcoholic beverages; reduction in cigarettes, inhalants, marijuana, cocaine, and crack use; reduction of antisocial behavior; reduction of early pregnancy; improvement of school performance and reduction of school dropout.


These outcomes will be evaluated with the application of self-reporting instruments, answered by the children and adolescents. The data collection is performed in 4 moments: pre-test, post-test, 6 and 12 months follow-ups.

Secondary Outcome(s)

Secondary outcomes: improvement in family relationships quality; improvement in parenting practices, increase in self-efficacy for learning, improvement in future time perspective; increase in school engagement.


These outcomes will be evaluated with the application of self-reporting instruments, answered by the children and adolescents. The data collection is performed in 4 moments: pre-test, post-test, 6 and 12 months follow-ups.

Source(s) of Monetary Support

Secretaria Nacional de Políticas sobre Drogas - Ministério da Justiça

Instituto de Psicologia da Universidade de Brasília

Universidade de Brasília

Secondary Sponsor(s)

Secretaria Nacional de Políticas sobre Drogas - Ministério da Justiça

Universidade de Brasília