Effectiveness of a school model for the integral prevention of risk behaviors: a cluster-randomised trial

ISRCTN ISRCTN11345846
DOI https://doi.org/10.1186/ISRCTN11345846
Secondary identifying numbers EP15016.0 (internal number)/Grant No.PDCPN-2014-248428 (sponsor number)
Submission date
31/10/2017
Registration date
22/11/2017
Last edited
20/11/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Miss Nancy Gigliola Amador-Buenabad
Scientific

Clz. México-Xochimilco #101
col. San Lorenzo Huipulco
CP. 14370, delg. Tlalpan
Mexico City
14370
Mexico

Phone +52 (0)55 4160-5480
Email nagy@imp.edu.mx

Study information

Study designRandomized four-arm multisite controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA 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
Study objectivesThe 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(s)Ethics Committee of the Ramón de la Fuente Muñiz National Institute of Psychiatry (Mexico), 30/03/2015, ref: EP15016.0
Health condition(s) or problem(s) studiedConduct disorders prevention
InterventionThe 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 typeBehavioural
Primary outcome measureChildren'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 measures1. 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 study start date24/11/2014
Completion date03/02/2017

Eligibility

Participant type(s)Mixed
Age groupMixed
Lower age limit18 Years
SexBoth
Target number of participants378 in 4 clusters (n = 103, 110, 82, 83)
Key inclusion criteriaFor 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
Key exclusion criteriaDoes not meet the inclusion criteria
Date of first enrolment01/12/2015
Date of final enrolment26/01/2016

Locations

Countries of recruitment

  • Mexico

Study 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

National Council for Science and Technology (CONACYT) of Mexico, through the PDCPN-2014-248428 project
Government

Av. Insurgentes Sur 1582
Col. Crédito Constructor
Del. Benito Juárez
C.P. 03940
Ciudad de México
Mexico City
03940
Mexico

Phone +52 (0)55 5322 7708
Email cst@conacyt.mx
Website https://conacyt.gob.mx
ROR logo "ROR" https://ror.org/059ex5q34

Funders

Funder type

Government

Consejo Nacional de Ciencia y Tecnología
Government organisation / National government
Alternative name(s)
Consejo Nacional de Ciencia y Tecnología, National Council of Humanities, Sciences and Technologies, Mexican National Council of Science and Technology, National Council for Science and Technology (CONACyT), National Council of Science and Technology, Mexico, Conahcyt
Location
Mexico

Results and Publications

Intention to publish date02/02/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planOnce 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 planThe data sharing plans for the current study are unknown and will be made available at a later date.