Attention Deficit Disorder With HyperactivityPhase 3NCT00402857
Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
A Phase 3 study testing Incredible Years Program in people with Attention Deficit Disorder With Hyperactivity and Attention Deficit and Disruptive Behavior Disorders, run by Tufts Medical Center at 9 sites in United States.
Trial summary
This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders. Read more about this study
- Who is it for?
- Ages 22 to 38 monthsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Attention Deficit and Disruptive Behavior Disorders
- What is being tested?
- Incredible Years Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2006to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 38 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or primary caregiver of a child who fits the following criteria:
- Receives a positive result on behavioral screening
Who cannot join
- Parent or primary caregiver of a child who fits the following criteria:
- Diagnosis of pervasive developmental disorder or global developmental delay
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
MGH Chelsea Healthcare Center
Chelsea, Massachusetts
Codman Square Health Center
Dorchester, Massachusetts, 02124
Martha Eliot Health Center
Jamaica Plain, Massachusetts, 02130
Medical Associates Pediatrics
Leominster, Massachusetts, 01453
Southboro Medical Group
Southborough, Massachusetts, 01772
Pediatrics West
Westford, Massachusetts, 01886
Westwood-Mansfield Pediatric Associates
Westwood, Massachusetts, 02090
Wilmington Pediatrics
Wilmington, Massachusetts, 01887
Woburn Pediatric Associates
Woburn, Massachusetts, 01801
About this study
Official title: Advanced Parenting Education in Pediatrics: The APEP Project
This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) are common childhood behavior disorders. Children with ADHD experience hyperactivity, distractibility, poor concentration, and impulsivity. If left untreated, ADHD can continue into adulthood, and can cause problems in family, social, and work environments. Children with ODD exhibit an ongoing pattern of uncooperative, defiant, and hostile behavior toward authority figures. Symptoms of ODD, including frequent temper tantrums, anger, resentment, and vindictiveness, may interfere with a child's everyday functioning. The Incredible Years parent training program has been shown to be effective in multiple settings at training parents to manage their child's behavior. This study will evaluate the effectiveness of the Incredible Years training program within a pediatric office setting at improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.
Participants in this open-label study will be randomly assigned to the Incredible Years training program or a waitlist condition, in which they will begin the program after a 1-year waiting period. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs. Self-report assessments and phone interviews will be used to assess outcomes. Additionally, follow-up visits will occur immediately post-intervention and 6 and 12 months post-intervention. Children will attend one visit before the program begins, as well as the follow-ups held immediately post-intervention and 12 months post-intervention. These visits will include videotaped observations of children and their primary caregivers.
- Conditions
- Attention Deficit Disorder With Hyperactivity, Attention Deficit and Disruptive Behavior Disorders
- Being tested
- Incredible Years Program
- Keywords
- Parenting Education, Child, Preschool, Preventive Intervention, Primary Health Care, Pediatrics, Attention Deficit Disorders, Oppositional Defiant Disorder, Disruptive Behavior Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Attention Deficit and Disruptive Behavior Disorders, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incredible Years ProgramBehavioural
The Incredible Years Program is a 10-week group parenting intervention. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive the Incredible Years Program, a group parenting intervention Receives: Behavioral: Incredible Years Program |
| 2 | Other | Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period Receives: Behavioral: Incredible Years Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting behavior
Measured: Measured post-intervention and at 6- and 12-month follow-ups
Child disruptive behaviors
Measured: Measured post-intervention and at 6- and 12-month follow-ups
Secondary outcomes (6)
Child and parent functional status/impairment
Measured: Measured post-intervention and at 6- and 12-month follow-ups
Parenting stress
Measured: Measured post-intervention and at 6- and 12-month follow-ups
Family functioning
Measured: Measured post-intervention and at 6- and 12-month follow-ups
Consumer perspectives
Measured: Measured post-intervention and at 6- and 12-month follow-ups
Cost of services
Measured: Measured post-intervention and at 6- and 12-month follow-ups
Barriers to treatment
Measured: Measured post-intervention and at 6- and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ellen C. Perrin, MD, Principal investigator, Tufts Medical CenterChristopher Sheldrick, PhD, Principal investigator, Tufts Medical CenterJannette McMenamy, PhD, Principal investigator, Fitchburg State College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402857
- Sponsor's protocol ID
- R01MH076244
- Other IDs
- R01MH076244, DSIR CT-C
- Status last verified
- Feb 2013
- First submitted
- 20 Nov 2006
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Perrin EC, Sheldrick RC, McMenamy JM, Henson BS, Carter AS. Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial. JAMA Pediatr. 2014 Jan;168(1):16-24. doi: 10.1001/jamapediatrics.2013.2919.
PubMed 24190691
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Parenting Education in Pediatrics: The APEP Project
- ClinicalTrials.gov ID
- NCT00402857
- Acronym / sponsor ID
- R01MH076244
- Conditions
- Attention Deficit Disorder With Hyperactivity, Attention Deficit and Disruptive Behavior Disorders
- Keywords
- Parenting Education, Child, Preschool, Preventive Intervention, Primary Health Care, Pediatrics, Attention Deficit Disorders, Oppositional Defiant Disorder, Disruptive Behavior Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.
Detailed description
Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) are common childhood behavior disorders. Children with ADHD experience hyperactivity, distractibility, poor concentration, and impulsivity. If left untreated, ADHD can continue into adulthood, and can cause problems in family, social, and work environments. Children with ODD exhibit an ongoing pattern of uncooperative, defiant, and hostile behavior toward authority figures. Symptoms of ODD, including frequent temper tantrums, anger, resentment, and vindictiveness, may interfere with a child's everyday functioning. The Incredible Years parent training program has been shown to be effective in multiple settings at training parents to manage their child's behavior. This study will evaluate the effectiveness of the Incredible Years training program within a pediatric office setting at improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.
Participants in this open-label study will be randomly assigned to the Incredible Years training program or a waitlist condition, in which they will begin the program after a 1-year waiting period. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs. Self-report assessments and phone interviews will be used to assess outcomes. Additionally, follow-up visits will occur immediately post-intervention and 6 and 12 months post-intervention. Children will attend one visit before the program begins, as well as the follow-ups held immediately post-intervention and 12 months post-intervention. These visits will include videotaped observations of children and their primary caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Incredible Years ProgramParticipants will receive the Incredible Years Program, a group parenting intervention |
| 2 | Other | Behavioral: Incredible Years ProgramParticipants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period |
Who may qualify
- Ages
- 22 to 38 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Receives a positive result on behavioral screening
Key exclusion criteria (2 listed)
- Diagnosis of pervasive developmental disorder or global developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incredible Years ProgramThe Incredible Years Program is a 10-week group parenting intervention. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs. | Behavioural | 1, 2 |
Primary outcome
Parenting behavior
Time frame: Measured post-intervention and at 6- and 12-month follow-ups
Child disruptive behaviors
Time frame: Measured post-intervention and at 6- and 12-month follow-ups
6 secondary outcomes
Child and parent functional status/impairment
Time frame: Measured post-intervention and at 6- and 12-month follow-ups
Parenting stress
Time frame: Measured post-intervention and at 6- and 12-month follow-ups
Family functioning
Time frame: Measured post-intervention and at 6- and 12-month follow-ups
Consumer perspectives
Time frame: Measured post-intervention and at 6- and 12-month follow-ups
Cost of services
Time frame: Measured post-intervention and at 6- and 12-month follow-ups
Barriers to treatment
Time frame: Measured post-intervention and at 6- and 12-month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Derived from this study: PubMed 24190691Perrin EC, Sheldrick RC, McMenamy JM, Henson BS, Carter AS. Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial. JAMA Pediatr. 2014 Jan;168(1):16-24. doi: 10.1001/jamapediatrics.2013.2919.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen C. Perrin, MD principal investigator
Tufts Medical Center
Christopher Sheldrick, PhD principal investigator
Tufts Medical Center
Jannette McMenamy, PhD principal investigator
Fitchburg State College
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Incredible Years Program in people with Attention Deficit Disorder With Hyperactivity and Attention Deficit and Disruptive Behavior Disorders, run by Tufts Medical Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting behavior (time frame: Measured post-intervention and at 6- and 12-month follow-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.