Condition category
Mental and Behavioural Disorders
Date applied
26/04/2016
Date assigned
28/04/2016
Last edited
28/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

Institute of Education Sciences (USA)

Sponsor details

555 New Jersey Avenue NW
Washington DC
20208
United States of America

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes