Condition category
Mental and Behavioural Disorders
Date applied
31/10/2017
Date assigned
22/11/2017
Last edited
20/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

https://conacyt.gob.mx

Funders

Funder type

Government

Funder name

Consejo Nacional de Ciencia y Tecnología

Alternative name(s)

National Council of Science and Technology, Mexico, 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes