Attention Deficit Hyperactivity DisorderNCT01320098
Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers
A study testing Home-Based Parenting Program and Clinic-Based Parenting Program in people with Attention Deficit Hyperactivity Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this research is to evaluate and compare the effectiveness of two parenting programs in reducing the ADHD symptoms and behavioral problems of preschool children with ADHD through a controlled study. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Home-Based Parenting Program and Clinic-Based Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2014
- Phase
- Interventional
- 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 3 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age = 3.0 - 4.11
- In preschool program at least 2 half days per week
- Meets criteria for ADHD on clinical evaluation / DISC
- ADHD severity: > 1.5 SD above mean for age/sex on CTRS-R
- ADHD severity: > 1.0 SD above mean for age/sex on CPRS-R
Who cannot join
- Current Medication treatment for ADHD
- IQ < 70 (Full Scale on WPPSI III)
- Pervasive Developmental Disorder
- Psychosis
- Severe receptive language impairment
- Neurological Disorder
Show all 9Show fewer
- Significant medical disorder
- Primary caretaker is not able to participate
- Non-English speaking primary care taker
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Child Study Center, One Park Avenue
New York, New York, 10016
About this study
Official title: Home-Based Parent Training in ADHD Preschoolers
The purpose of this research is to evaluate and compare the effectiveness of two parenting programs in reducing the ADHD symptoms and behavioral problems of preschool children with ADHD through a controlled study. One program is a home-based parent training intervention that is designed to enhance the parent-child interaction, constructive parenting skills, and the child's tolerance for delay. The other intervention is a clinic-based parent training program that focuses on reducing noncompliance in preschool children and improving parenting skills.
Both programs consist of private weekly parenting sessions with Clinical Psychologists - once a week for 8 weeks. The sessions are 1-1.5 hours in length. Both programs use behavior modification as a means of improving oppositional and non-compliant child behavior. Both interventions also involve procedures that focus on improving children's attention.
Neither program involves medication, and all families will receive one of the two parenting programs being evaluated. Study evaluations, as well as participation in the parenting programs, are provided at no cost to families. Evaluation and parenting sessions can be scheduled at times convenient to families.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Home-Based Parenting Program, Clinic-Based Parenting Program, Wait-List Control Group
- Keywords
- Attention, Behavior Problems, Compliance, Evaluation, Preschool, ADHD, Overactive, Inattentive, Attention Deficit Hyperactivity Disorder in Preschoolers
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Mental Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Parenting ProgramBehavioural
The Home-Based Parenting Program aims to improve impulsive and oppositional behaviors in 3 and 4 year-olds. The program involves 8 home visits with a therapist. The visits focus on the skills listed below as a means of improving your child's behavior.
- Helping you set developmentally appropriate goals for your child. One way we do this is by focusing on situations that occur naturally in your home. Another way is by having you engage in activities with your child that focus on improving attention and the ability to delay.
- Increasing the quality and quantity of positive interactions between you and your child
- Changing the way you respond to your child's inappropriate behaviors so as to reduce the frequency of negative interactions.
- Improving your parenting skills. This program also includes between-session "homework tasks" so that you can practice the skills you have learned throughout the week.
Clinic-Based Parenting ProgramBehavioural
The Clinic-Based Parenting Program aims to improve ADHD symptoms by reducing noncompliance, which is common in children with ADHD. Parents learn how to help their child attend to and comply with requests and directions so as to improve compliance and attention.
The program involves 8 clinic visits with a therapist. Parents learn various parenting skills to help improve their child's behaviors.
Parents learn techniques and skills to promote positive interactions with their child, including:
- Increasing the positive attention you give to your child.
- Reducing the inappropriate use of commands, questions and criticisms.
- Appropriate use of praise and physical attention (e.g., hugs) as rewards.
- Actively ignoring minor, inappropriate behaviors. Parents also learn how to: increase compliance via clear instruction; respond to compliant and noncompliant behaviors; and create and use clear rules about appropriate and inappropriate child behaviors.
Wait-List Control GroupBehavioural
If your child is randomized to the 8-week Wait-List group, you and your child will be asked to attend 2 assessment visits -1 screening/baseline visit and one 8 weeks later. These assessment visits will take place at our clinic. After completing the second assessment, you will receive your choice of either the home-based or clinic-based parenting program.
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Parenting Program | Experimental | Not described Receives: Behavioral: Home-Based Parenting Program |
| Clinic-Based Parenting Program | Experimental | Not described Receives: Behavioral: Clinic-Based Parenting Program |
| Wait-List Control Group | Other | Not described Receives: Behavioral: Wait-List Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners Teacher Rating Scale
Behavior Rating Scale
Measured: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
Secondary outcomes (1)
Conners Parent Rating Scale
Behavior Rating Scale
Measured: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startJan 2007
- Primary completionNov 2014
- Study completionNov 2014
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 Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Abikoff, Ph.D., Principal investigator, New York University Child Study Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320098
- Sponsor's protocol ID
- 5R01MH074556-04
- Status last verified
- Dec 2014
- First submitted
- 11 Mar 2011
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Abikoff HB, Thompson M, Laver-Bradbury C, Long N, Forehand RL, Miller Brotman L, Klein RG, Reiss P, Huo L, Sonuga-Barke E. Parent training for preschool ADHD: a randomized controlled trial of specialized and generic programs. J Child Psychol Psychiatry. 2015 Jun;56(6):618-31. doi: 10.1111/jcpp.12346. Epub 2014 Oct 16.
PubMed 25318650
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Parent Training in ADHD Preschoolers
- ClinicalTrials.gov ID
- NCT01320098
- Acronym / sponsor ID
- 5R01MH074556-04
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention, Behavior Problems, Compliance, Evaluation, Preschool, ADHD, Overactive, Inattentive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Mar 2011 (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.
The purpose of this research is to evaluate and compare the effectiveness of two parenting programs in reducing the ADHD symptoms and behavioral problems of preschool children with ADHD through a controlled study. One program is a home-based parent training intervention that is designed to enhance the parent-child interaction, constructive parenting skills, and the child's tolerance for delay. The other intervention is a clinic-based parent training program that focuses on reducing noncompliance in preschool children and improving parenting skills.
Both programs consist of private weekly parenting sessions with Clinical Psychologists - once a week for 8 weeks. The sessions are 1-1.5 hours in length. Both programs use behavior modification as a means of improving oppositional and non-compliant child behavior. Both interventions also involve procedures that focus on improving children's attention.
Neither program involves medication, and all families will receive one of the two parenting programs being evaluated. Study evaluations, as well as participation in the parenting programs, are provided at no cost to families. Evaluation and parenting sessions can be scheduled at times convenient to families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home-Based Parenting Program | Experimental | Behavioral: Home-Based Parenting Program |
| Clinic-Based Parenting Program | Experimental | Behavioral: Clinic-Based Parenting Program |
| Wait-List Control Group | Other | Behavioral: Wait-List Control Group |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age = 3.0 - 4.11
- In preschool program at least 2 half days per week
- Meets criteria for ADHD on clinical evaluation / DISC
- ADHD severity: > 1.5 SD above mean for age/sex on CTRS-R
- ADHD severity: > 1.0 SD above mean for age/sex on CPRS-R
Key exclusion criteria (9 listed)
- Current Medication treatment for ADHD
- IQ < 70 (Full Scale on WPPSI III)
- Pervasive Developmental Disorder
- Psychosis
- Severe receptive language impairment
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 |
|---|---|---|
| Home-Based Parenting ProgramThe Home-Based Parenting Program aims to improve impulsive and oppositional behaviors in 3 and 4 year-olds. The program involves 8 home visits with a therapist. The visits focus on the skills listed below as a means of improving your child's behavior. 1. Helping you set developmentally appropriate goals for your child. One way we do this is by focusing on situations that occur naturally in your home. Another way is by having you engage in activities with your child that focus on improving attention and the ability to delay. 2. Increasing the quality and quantity of positive interactions between you and your child 3. Changing the way you respond to your child's inappropriate behaviors so as to reduce the frequency of negative interactions. 4. Improving your parenting skills. This program also includes between-session "homework tasks" so that you can practice the skills you have learned throughout the week. | Behavioural | Home-Based Parenting Program |
| Clinic-Based Parenting ProgramThe Clinic-Based Parenting Program aims to improve ADHD symptoms by reducing noncompliance, which is common in children with ADHD. Parents learn how to help their child attend to and comply with requests and directions so as to improve compliance and attention. The program involves 8 clinic visits with a therapist. Parents learn various parenting skills to help improve their child's behaviors. Parents learn techniques and skills to promote positive interactions with their child, including: 1. Increasing the positive attention you give to your child. 2. Reducing the inappropriate use of commands, questions and criticisms. 3. Appropriate use of praise and physical attention (e.g., hugs) as rewards. 4. Actively ignoring minor, inappropriate behaviors. Parents also learn how to: increase compliance via clear instruction; respond to compliant and noncompliant behaviors; and create and use clear rules about appropriate and inappropriate child behaviors. | Behavioural | Clinic-Based Parenting Program |
| Wait-List Control GroupIf your child is randomized to the 8-week Wait-List group, you and your child will be asked to attend 2 assessment visits -1 screening/baseline visit and one 8 weeks later. These assessment visits will take place at our clinic. After completing the second assessment, you will receive your choice of either the home-based or clinic-based parenting program. | Behavioural | Wait-List Control Group |
Primary outcome
Conners Teacher Rating Scale
Time frame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
Behavior Rating Scale
1 secondary outcome
Conners Parent Rating Scale
Time frame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
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 8 Dec 2014.
- Derived from this study: PubMed 25318650Abikoff HB, Thompson M, Laver-Bradbury C, Long N, Forehand RL, Miller Brotman L, Klein RG, Reiss P, Huo L, Sonuga-Barke E. Parent training for preschool ADHD: a randomized controlled trial of specialized and generic programs. J Child Psychol Psychiatry. 2015 Jun;56(6):618-31. doi: 10.1111/jcpp.12346. Epub 2014 Oct 16.
- Related InfoLink provided by the sponsor.
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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.
Howard Abikoff, Ph.D. principal investigator
New York University Child Study Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Parenting Program and Clinic-Based Parenting Program in people with Attention Deficit Hyperactivity Disorder, run by NYU Langone Health at 1 site 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 5 inclusion and 9 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Conners Teacher Rating Scale (time frame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)). 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 NCT01320098, 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 8 Dec 2014; AzTrials last refreshed its copy on 31 Oct 2026.