NCT01547702

Brief Summary

The purpose of this study is to evaluate, by way of randomized controlled trial, the effectiveness of a web-based, time-flexible, and teacher-directed "Teacher Help for ADHD" program in reducing the impact of ADHD symptoms in elementary students.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

February 27, 2012

Last Update Submit

March 27, 2014

Conditions

Keywords

ADHDattentioninattentionhyperactivityclassroom interventionteacher educationweb-based intervention

Outcome Measures

Primary Outcomes (1)

  • The Impairment Rating Scale (IRS, Fabiano & Pelham, 2002)

    The IRS will be the primary outcome measure in our study because it assesses the areas of functioning that are impacted most by the symptoms of ADHD. It consists of six questions on the teacher version and seven questions on the parent version, which measure the child's academic, behavioural, relational functioning and self-esteem.

    Change from Baseline in ADHD symptom impairment at 6 weeks (length of intervention) and 12 weeks (follow-up)

Secondary Outcomes (10)

  • Knowledge of Attention Deficit Disorder Scale (KADDS; Sciutto, Terjesen, & Bender, 2000)

    Change from Baseline in ADHD knowledge at 6 weeks (length of intervention) and 12 weeks (follow-up)

  • Beliefs about Attention Deficit Hyperactivity Disorder (Kos, 2008)

    Change from Baseline in ADHD beliefs at 6 weeks (length of intervention) and 12 weeks (follow-up)

  • Instructional and Behavior Management Approaches Survey (IBMA; Martinussen, Tannock, & Chaban, 2011)

    Change from Baseline in behaviour management approaches at 6 weeks (length of intervention) and 12 weeks (follow-up)

  • Intention and Subjective Norm questionnaires (Based on Prochaska & DiClemente's Stages of Change Model, 1984)

    Change from Baseline in intentions and subjective norms at 6 weeks (length of intervention) and 12 weeks (follow-up)

  • Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP; see Murray, Bussing, Fernandez, Hou, Garvan, Swanson, & Eyberg, 2009)

    Functional impairment of ADHD symptoms will be measured in the Treatment group at 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, and 7 weeks

  • +5 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

This group will have access to the Teacher Help for ADHD intervention program during the randomized controlled trial.

Behavioral: Teacher Help for ADHD

Waitlist Control

NO INTERVENTION

This group will not receive the intervention until all data collection is complete for their study cohort.

Interventions

Teachers will review powerpoints other materials online and will have access to a study coach to assist with their understanding and practical application of the materials. Session descriptions follow: * Session 1: Provide information about ADHD characteristics, impact, diagnosis, etiology * Session 2: Help establish teacher's role; goal setting; introduce behaviour planning * Session 3: Help develop and implement behaviour program specific to the needs of students with Session 2 goals * Session 4: Help develop strategies re: classroom structure, work assignments, teacher-student relationship * Session 5: Help to use instructional interventions for ADHD * Session 6: Help to teach these students self-monitoring and self-evaluation skills; help teachers to evaluate progress, phase out behaviour program, and plan for relapses in unwanted behaviours

Treatment

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Student is in grades 1 to 6 in the public school English stream
  • Student has been formally diagnosed with Attention Deficit Hyperactivity Disorder having a diagnosis of ADHD
  • Student is either on a stable dose of medication or no medication with no plan to start/change medication in the next 5 months

You may not qualify if:

  • Student has a significant other mental health issue (e.g., depression, anxiety, suicidal ideation, psychotic features, and severe conduct problems)
  • Student is on an Individualized Program Plan (IPP) due to significant physical, behavioural, communication, or learning difficulties.
  • Teacher participated in the Teacher Help for ADHD pilot study (conducted by Brittany Barnett, Master of Health Informatics Student under the supervision of Dr. Elik and Dr. Corkum, Dalhousie University)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 4J1, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySpasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Penny V Corkum, PhD

    Dalhousie University

    PRINCIPAL INVESTIGATOR
  • Nezihe Elik, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 8, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations