Condition category
Mental and Behavioural Disorders
Date applied
21/09/2015
Date assigned
08/10/2015
Last edited
08/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A growing number of school-age children are showing behavioral problems at home and at school. Many studies have shown that problem behavior in young children can get worse with age, and can even affect their mental health as adults. It is therefore important to a healthy childhood development that behavioral problems are addressed early on. Parent education programs have been proven to be very successful at improving child behavior. It has been found however that families in ethnic minorities are a hard-to-reach group for this type of program. A possible reason for this may stem from cultural differences, and differences in parenting styles to the general population. The ‘Incredible Years’ school age program is a basic parenting program that is designed to strengthen the relationship between parents and children. Through the use of videos, group discussions and problem-solving exercises, parents are taught to better manage the behaviour of their children. This program has shown remarkable success in many different ethnic groups worldwide in improving child behavior and performance in school. The aim of this study is to find out whether the Incredible Years program is would work well for Filipino parents in America.

Who can participate?
Filipino parents aged 18 or over, of a child between 6 and 12 years old.

What does the study involve?
Participants are randomly allocated into one of two groups. Parents in the first group immediately begin a 12 week video-based parent education program (Incredible Years). Participants are asked to complete a survey asking about how their child behaves at home and at school, and about their own parenting techniques. After each session of the program, participants are asked to fill out a questionnaire about their opinions of the session leaders and the content of the sessions. Parents allocated into the second group are enrolled in the program three months later. At the end of the intervention and again 12 weeks later, participants undertake a number of questionnaire to measure their stress levels and satisfaction with the program, as well as the children’s behaviour and parenting methods used.

What are the possible benefits and risks of participating?
A potential benefit is that participants may learn parenting skills that can help to improve their children’s’ behaviour and success in school. There are no significant risks of participating, although some people may find the topics discussed or questions asked can be embarrassing or upsetting.

Where is the study run from?
Children's Hospital Los Angeles (USA)

When is the study starting and how long is it expected to run for?
July 2011 to September 2012

Who is funding the study?
1. Southern California Clinical and Translational Science Institute (USA)
2. National Institutes of Health (USA)
3. National Center for Advancing Translational Sciences (USA)
4. National Center for Research Resources (USA)

Who is the main contact?
Dr Joyce Javier

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joyce Javier

ORCID ID

http://orcid.org/0000-0002-6224-6044

Contact details

4650 Sunset Blvd. MS# 76
Los Angeles
90027
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prevention of behavioral problems in Filipino youths with an evidence-based parenting intervention: A faith-based randomized pilot study

Acronym

Study hypothesis

The aim of this study is to provide preliminary data about the efficacy and feasibility of the Incredible Years School Age Parent Training Program when offered in a community faith-based setting to Filipino parents.

Ethics approval

Children’s Hospital Los Angeles Institutional Review Board, ref: CCI-11-00182

Study design

Community-based single-centre pilot randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Child behavioral problems

Intervention

Participants were randomized using a random number generator to one of two conditions:

1. Participants enrolled in the Incredible Years School Age Parent Program immediately
2. Participants enrolled in the Incredible Years School Age Parent Program 3-months later

The intervention is the Incredible Years School Age BASIC Parent Program for parents of children ages six to 12 years. The social cognitive learning theory based program shows vignettes of real parents from diverse backgrounds modeling parenting skills in effective and ineffective ways. Group leaders also coach role plays with participants and then debrief the group about what the participants did well and how it felt to play the role of the parent or the child.
Parents in the experimental group attended a series of 12 weekly 2-hour sessions. A follow up assessment was performed at baseline, after the intervention and 12 weeks later. The intervention was subsequently repeated with the control group.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Parenting practices are measured using the LIFT Parenting Practices Index at baseline, after the intervention and 12 weeks later.

Secondary outcome measures

1. Child behavior is measured using the Achenbach Child Behavior Checklist at baseline, after the intervention and 12 weeks later
2. Parental stress is measured using the Parenting Stress Index-Short Form at baseline, after the intervention and 12 weeks later
3. Satisfaction is assessed by the Parent Satisfaction Questionnaire. This is a 40-item Likert type scale that measures parent satisfaction regarding overall program, teaching format, specific parenting techniques, evaluation of group leaders, and feeling about the parent group. It was created by developer of Incredible Years

Overall trial start date

03/07/2011

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Parent or legal guardian of a child who is between ages 6-12 years of age
3. Nationality Filipino American
4. Participant is willing to complete pre- and post- surveys, participate in a 12 week program entitled the Incredible Years
5. Fluent in English

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

28

Participant exclusion criteria

1. Target child has developmental disabilities

Recruitment start date

01/09/2011

Recruitment end date

31/01/2012

Locations

Countries of recruitment

United States of America

Trial participating centre

Children's Hospital Los Angeles
4650 Sunset Blvd MS#76
Los Angeles
90027
United States of America

Sponsor information

Organisation

Children's Hospital Los Angeles

Sponsor details

4650 Sunset Blvd. MS #76
Los Angeles
90027
United States of America

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Southern California Clinical and Translational Science Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institutes of Health

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

National Center for Advancing Translational Sciences

Alternative name(s)

NCATS

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

National Center for Research Resources

Alternative name(s)

NCRR

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Publication in a peer reviewed journal.

Intention to publish date

01/04/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes