Plain English Summary
Background and study aims
Multiple component interventions have proved to reduce the severity or the development of risk factors that can lead to problems in childhood and adolescence. It has been found that school programs that involve families and the community are more effective than programs that target only the children. The main aim of this study is to assess the effectiveness of the simultaneous administration of two interventions, both aimed at the reduction of children problematic behavior, one through the enhancement of social skills among children, and the other through the improvement of the parenting skills of their caregivers. The second aim is to find out whether the effect of the interventions persists 3 and 7 months after the interventions.
Who participated?
Children, their caregivers and their teachers from four public primary school of Mexico City
What does the study involve?
Participating schools are randomly allocated to one of four interventions. The Huellitas intervention aims at the development of social skills in children and is administered by trained teachers. The CAPAS-Mx intervention focuses on the reduction of children's problematic behavior through the training of their caregiver's parenting skills. The simultaneous intervention (Huellitas-CAPAS-Mx) consists of the administration of both programs in the same school. The fourth school is put on a waiting list and receives both interventions 3 months after the interventions are finished in the other schools. Caregivers' parenting skills and their children's conduct behavior are social skills are assessed at the start of the study and 12, 24 and 36 weeks later.
What are the possible benefits of participating?
Caregivers have the opportunity to learn and practice different positive parenting strategies under the guidance of trained professionals. Children can benefit from learning new social skills that can improve their school and family interactions. Teachers are able to guide their students, reducing problems in the classroom. Caregivers, teachers and children can improve their mental health. The social benefit is high if actions are taken at critical stages of development.
Where is the study run from?
Ramon de la Fuente Muñiz National Institute of Psychiatry, México City (México)
When is the study starting and how long is it expected to run for?
November 2014 to February 2017
Who is funding the study?
The National Council for Science and Technology (CONACyT) (Mexico)
Who is the main contact?
Nancy G. Amador Buenabad
nagy@imp.edu.mx
Trial website
Contact information
Type
Scientific
Primary contact
Miss Nancy Gigliola Amador-Buenabad
ORCID ID
Contact details
Clz. México-Xochimilco #101
col. San Lorenzo Huipulco
CP. 14370
delg. Tlalpan
Mexico City
14370
Mexico
+52 (0)55 4160-5480
nagy@imp.edu.mx
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EP15016.0 (internal number)/Grant No.PDCPN-2014-248428 (sponsor number)
Study information
Scientific title
A four-arm, cluster-randomised study to evaluate the effectiveness of a multicomponent intervention to prevent risk behaviors in Mexican students through the development of social skills in children and positive parenting in their caregivers
Acronym
Study hypothesis
The multicomponent intervention will have a greater effect at reducing behavioral problems and increasing social skills in children and the positive parenting strategies of their caregivers vs. individual interventions.
The null hypothesis is that the multicomponent intervention will not have significant differences when compared with the individual interventions.
Ethics approval
Ethics Committee of the Ramón de la Fuente Muñiz National Institute of Psychiatry (Mexico), 30/03/2015, ref: EP15016.0
Study design
Randomized four-arm multisite controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Conduct disorders prevention
Intervention
The four participating schools were randomly assigned to four conditions:
1. Dejando Huellitas en tu vida (Huellitas) (Making trails in your life)/Huellitas): a social skills program for children, administered by supervised trained teachers in 12 weekly sessions (60 minutes each). The main topics are:
1.1. Personal aspects of the child, such as expressing and respecting each other's emotions and opinions
1.2. Prevention of abuse and maltreatment
1.3. Their relationships in their school and family environments
1.4. Equity, non-discrimination and self acceptance
2. Criando con Amor, Promoviendo Armonía y Superación en México (CAPAS-MX) (Raising Children with Love, Promoting Harmony and Self-Improvement/CAPAS-MX): a parenting intervention program to reduce children problematic behavior. Parents were trained by supervised professionals in 12 weekly sessions (90 minutes each) in which caregivers learned:
2.1. Positive involvement
2.2. Promoting the development of new skills
2.3. Effective discipline
2.4. Monitoring
2.5. Problem solving
3. Huellitas-CAPAS-Mx: the simultaneous implementation of both interventions previously described
4. Control group: a waiting list group that took both interventions 3 months after the interventions were ended in the other experimental conditions.
The training of both teachers and caregivers was performed by professionals that supervised the fidelity of the interventions. Assessments were made prior and after the interventions. As for the experimental conditions, schools, participants, teaching staff and assessment supervisors, and the statistical analyst were blinded throughout the study, until the pre-test was completed. It all started with an assessment of the caregivers about their parenting skills and their children's conduct behavior. Then the kids were assessed about their social skills. They were measured at baseline and then three times again: 12, 24 and 36 weeks after randomization.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Children's problematic behavior, measured with the Child Behavior Checklist for Ages 6-18 (CBCL/6-18; Achenbach & Rescorla, 2001). A self-report questionnaire completed by caregivers.
Measured at baseline with three follow-up assessments: one post-treatment assessment at the end of the 12 weeks treatment phase, a first follow-up assessment at 24 weeks after randomization (Follow-Up 1) and a second follow-up (Follow-up 2) 36 weeks after randomization.
Secondary outcome measures
1. Children's social skills, measured with the Social Skills Questionnaire for Girls and Boys (Villatoro et al., 2011), which measures resistance to social pressure, assertiveness, autonomy, mediation, self acceptance, self image, bullying, tolerance to failure, consistency in activities, and persistence.
2. Parenting practices (Amador 2014): five different scales were used to inquire about positive involvement, promoting development of new skills, effective discipline, supervision, and problem solving
Measured at baseline with three follow-up assessments: one post-treatment assessment at the end of the 12 weeks treatment phase, a first follow-up assessment at 24 weeks after randomization (Follow-Up 1) and a second follow-up (Follow-up 2) 36 weeks after randomization.
Overall trial start date
24/11/2014
Overall trial end date
03/02/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
For caregivers (parent or person who spends the most time taking care of the child):
1. At least 18 years old
2. Spend time with the child on a regular basis
3. Accept to participate
4. Complete the pre-test assessment
For children:
1. In 2nd, 4th or 5th grade of primary school
2. Have an authorization by the legal caregiver to participate in the study
3. Accept to participate
4. At least one of his/her caregivers accepts to participate in the study
5. Complete the pre-test assessment
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
378 in 4 clusters (n = 103, 110, 82, 83)
Participant exclusion criteria
Does not meet the inclusion criteria
Recruitment start date
01/12/2015
Recruitment end date
26/01/2016
Locations
Countries of recruitment
Mexico
Trial participating centre
Ramon de la Fuente Muñiz National Institute of Psychiatry
Calz. México-Xochimilco #101
Col. San Lorenzo Huipulco
CP. 14370, Delg. Tlalpan
Mexico City
14370
Mexico
Sponsor information
Organisation
National Council for Science and Technology (CONACYT) of Mexico, through the PDCPN-2014-248428 project
Sponsor details
Av. Insurgentes Sur 1582
Col. Crédito Constructor
Del. Benito Juárez
C.P. 03940
Ciudad de México
Mexico City
03940
Mexico
+52 (0)55 5322 7708
cst@conacyt.mx
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Consejo Nacional de Ciencia y Tecnología
Alternative name(s)
CONACYT
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Mexico
Results and Publications
Publication and dissemination plan
Once the first paper is published the protocol and other information about the study will be available at http://www.uade.inpsiquiatria.edu.mx/
Expected publications:
1. Two original articles are going to be submitted to peer reviewed journals
2. Two bachelor's degree thesis
3. Three master's degree thesis
4. 5 posters at the Annual Reunion of Research at the National Institute of Psychiatry Ramón de la Fuente Muñiz
5. 2 posters at the Inter-American Psychology Conference
6. 1 oral presentation of the results at a prestigious scientific congress or academic meeting
Dissemination plan:
1. 1 scientific dissemination article
2. 5 dissemination videos in social media
3. 1 meeting with decision makers
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
02/02/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list