Plain English Summary
Background and study aims
The aim of this study is to compare the effectiveness of two interventions for students with disruptive behaviour disorders: a home-based intervention to support parents (homeBase) and a school-based intervention to support students and teachers (First Step NEXT).
Who can participate?
Children in kindergarten (5 years old) through 3rd grade (10 years old) with disruptive behaviour disorders, and their parents and teachers
What does the study involve?
Participating children are randomly allocated to one of four interventions: First Step NEXT only, HomeBase-only, both First Step NEXT and homeBase, or usual care. Teachers of children allocated to First Step NEXT only or First Step NEXT plus homeBase receive expert training in the First Step NEXT program and ongoing in-class support from a behavioral coach. Parents of children allocated to homeBase only or First Step NEXT plus homeBase receive up to six 60-minute home visitation sessions with a behavioural coach. Teachers of children allocated to homeBase only do not receive any training or support from a behavioral coach, but they are asked to complete a log to identify typical services received. Parents of children allocated to First Step NEXT only do not receive any training or support from a trained behavioral coach, but they attend the initial parent-teacher-coach meeting, complete the daily parent-teacher home note, and are asked to complete a log to identify typical services received. Teachers and parents allocated to usual care do not receive any support from behavioral coaches or our research team, but they are asked to complete the log. The child’s behaviour is assessed before and after the interventions and at 6-months follow-up. Focus groups are also conducted with parents, teachers, support staff and school administrators.
What are the possible benefits and risks of participating?
There are several benefits. Both children and caregivers selected for this study may have improved health and mental wellbeing from participating in the services provided through this study. The results from this study could provide evidence for the continued use of this intervention with other children and families. The study’s results could also help schools provide effective and appropriate services in the future. There is an ultimate benefit to society in creating an effective early intervention program. The main risk is that participants may feel uncomfortable in answering personal questions.
Where is the study run from?
University of Louisville (USA)
When is the study starting and how long is it expected to run for?
January 2015 to January 2019
Who is funding the study?
Institute of Education Sciences (USA)
Who is the main contact?
Dr Andy Frey
afrey@louisville.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andy Frey
ORCID ID
Contact details
Kent School of Social Work
University of Louisville
Louisville
40292
United States of America
+1 (0)5028520431
afrey@louisville.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R324A150179
Study information
Scientific title
Efficacy of enhanced first step to success intervention for tertiary-level students with disruptive behavior
Acronym
Study hypothesis
We hypothesize that there will be a significant additive effect indicating the students assigned to the school-plus-home condition will demonstrate significantly greater change on the outcomes compared to the students receiving only one or none of the intervention components. We also expect that students randomized to conditions receiving the school module will demonstrate greater improvement in functioning within the school setting as compared to students randomized to the home-only or usual care conditions (i.e., the unique effect of the school module on the school setting). Conversely, we hypothesize children and parents in triads randomized to conditions receiving the home module will demonstrate greater improvement in functioning within the home setting as compared to children and parents in triads randomized to the school-only or usual care conditions (i.e., the unique effect of the home module on the home setting).
Ethics approval
University of Louisville Human Protection, 27/05/2015, IRB # 15.0315
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Disruptive behavior disorders
Intervention
A comparative effectiveness study examining the impact of a home-based intervention to support parents (homeBase) and a school-based intervention to support students and teachers (First Step NEXT) for students with disruptive behavior disorders who require tertiary-level support. We will systematically vary the levels of two factors, First Step NEXT (factor 1) and homeBase (factor 2).
Participants are randomly assigned to one of four conditions:
1. First Step NEXT only
2. HomeBase-only
3. First Step NEXT -plus-homeBase
4. Usual care
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Social competency - Social Skills Improvement System Rating Scales (baseline, post test, and 6-month follow up)
2. Problem behavior - Child Behavior Checklist (externalizing subscale) and FAST parent-child observation system (baseline, post test, and 6-month follow up)
3. Parenting practices - FAST parent-child observation system (baseline, post test)
4. Academic engaged time - Systematic Screening for Behavior Disorders (Academic engaged time observation system) (baseline, post test)
Secondary outcome measures
1. Parent motivation and perceptions of parenting - Parent motivation scale (baseline, post test, and 6-month follow up)
2. Student teacher relationships - Student-teacher Relationship Scale
3. Teacher classroom management efficacy- Teacher efficacy scale (classroom management subscale)
Overall trial start date
07/01/2015
Overall trial end date
06/01/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female students
2. Kindergarten (5 years old) through 3rd grade (10 years old)
3. Must pass first two gates of the Systematic Screening for Behavior Disorders screening and exceed the borderline threshold on the externalizing subscale of the CBCL (PRF)
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
400
Participant exclusion criteria
Severe developmental delays
Recruitment start date
09/01/2015
Recruitment end date
11/01/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
University of Louisville
40292
United States of America
Funders
Funder type
Government
Funder name
Institute of Education Sciences
Alternative name(s)
IES
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary