Attention Deficit Hyperactivity DisorderNCT03685279
Efficacy of the Nurtured Heart Approach to Reduce ADHD Behaviors in Children
A study testing Nurtured Heart Approach in people with Attention Deficit Hyperactivity Disorder, run by University of Arizona at 1 site in United States.
Trial summary
This study evaluates the efficacy of the Nurtured Heart Approach (NHA) to reduce inattention and hyperactivity and impulsivity in children ages 6 - 8 years. Participants are parents or guardians of children diagnosed with, or suspected of, attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Nurtured Heart Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 30 Jun 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or guardian of a child diagnosed with ADHD or suspected of ADHD
- Child must be 6 - 8 years of age
- Access to a computer with Internet
Who cannot join
- Child with ADHD, or suspected of ADHD, cannot have a diagnosis of autism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Efficacy of the Nurtured Heart Approach: A Randomized Controlled Trial
This study evaluates the efficacy of the Nurtured Heart Approach (NHA) to reduce inattention and hyperactivity and impulsivity in children ages 6 - 8 years. Participants are parents or guardians of children diagnosed with, or suspected of, attention deficit hyperactivity disorder (ADHD). Participants are randomized into the immediate (NHA) or delayed (Control) group.
Read the detailed description
The American Academy of Pediatrics recommends evidence-based parent and/or teacher behavioral therapy and/or medication to treat ADHD. A systematic review by Coates and colleagues found behavioral interventions decreased ADHD behaviors in children. The NHA is an intervention designed to teach parents a set of skills and attitudes to decrease ADHD in children. It has been applied in a number of settings from homes, schools, and foster care agencies both in several states in the U.S. and in over 16 countries. While widely accepted, the Approach has not been evaluated using scientifically rigorous methods.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Nurtured Heart Approach
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurtured Heart ApproachBehavioural
Based on three stands designed to reduce negative reactivity from parents/guardians, increase positive interactions, and set firm, clear limits.
| Study group | Role | What they receive |
|---|---|---|
| NHA Group | Experimental | Six-week, online intervention with weekly, sequential, content knowledge and skills practice. Each week included recorded, slide presentations (narrated by the developer of the NHA, Howard Glasser); readings from "The Transforming the Intense Child Workbook" by Howard Glasser with Melissa Lowenstein; participants' skills practice, web postings, and live sessions with Howard Glasser and Advanced NHA Trainers. Receives: Behavioral: Nurtured Heart Approach |
| Control Group | Other | The Control Group received the same intervention after the collection of NHA Group post-intervention surveys. Receives: Behavioral: Nurtured Heart Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inattention
Parent reported measure called Conners-3 Parent Short Form. Raw scores are converted into standardized T-scores using age- and sex-specific conversion standards. The minimum T-score is 40 and the maximum is 90. The six content subscales are inattention, hyperactivity/impulsivity, learning problems, executive function, defiance/aggression, and peer relations. Higher T-scores are worse.
Measured: Six-week change from pre-intervention inattention to post-intervention inattention.
Hyperactivity/Impulsivity
Parent reported measure called Conners-3 Parent Short Form. Raw scores are converted into standardized T-scores using age- and sex-specific conversion standards. The minimum T-score is 40 and the maximum is 90. The six content subscales are inattention, hyperactivity/impulsivity, learning problems, executive function, defiance/aggression, and peer relations. Higher T-scores are worse.
Measured: Six-week change from pre-intervention hyperactivity/impulsivity to post-intervention hyperactivity/impulsivity.
Secondary outcomes (2)
Parental Stress
Parent reported measure called Parenting Stress Index - 4 Short Form. Scores are summed. A minimum raw score possible is 36 and maximum is 180. Higher values are worse.
Measured: Six-week change from pre-intervention parental stress to post-intervention parental stress.
Parenting Competency
Parent reported measure called Parenting Sense of Competence. Scores are summed. A minimum score possible is 16 and maximum is 96. Higher value is a better outcome.
Measured: Six-week change from pre-intervention parenting competency to post-intervention parenting competency.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start14 Aug 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Velia Nuno, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685279
- Sponsor's protocol ID
- 1707672022
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2018
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of the Nurtured Heart Approach: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03685279
- Acronym / sponsor ID
- 1707672022
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 26 Sep 2018 (actual)
- 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 evaluates the efficacy of the Nurtured Heart Approach (NHA) to reduce inattention and hyperactivity and impulsivity in children ages 6 - 8 years. Participants are parents or guardians of children diagnosed with, or suspected of, attention deficit hyperactivity disorder (ADHD). Participants are randomized into the immediate (NHA) or delayed (Control) group.
Detailed description
The American Academy of Pediatrics recommends evidence-based parent and/or teacher behavioral therapy and/or medication to treat ADHD. A systematic review by Coates and colleagues found behavioral interventions decreased ADHD behaviors in children. The NHA is an intervention designed to teach parents a set of skills and attitudes to decrease ADHD in children. It has been applied in a number of settings from homes, schools, and foster care agencies both in several states in the U.S. and in over 16 countries. While widely accepted, the Approach has not been evaluated using scientifically rigorous methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NHA Group | Experimental | Behavioral: Nurtured Heart ApproachSix-week, online intervention with weekly, sequential, content knowledge and skills practice. Each week included recorded, slide presentations (narrated by the developer of the NHA, Howard Glasser); readings from "The Transforming the Intense Child Workbook" by Howard Glasser with Melissa Lowenstein; participants' skills practice, web postings, and live sessions with Howard Glasser and Advanced NHA Trainers. |
| Control Group | Other | Behavioral: Nurtured Heart ApproachThe Control Group received the same intervention after the collection of NHA Group post-intervention surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent or guardian of a child diagnosed with ADHD or suspected of ADHD
- Child must be 6 - 8 years of age
- Access to a computer with Internet
Key exclusion criteria (1 listed)
- Child with ADHD, or suspected of ADHD, cannot have a diagnosis of autism
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 |
|---|---|---|
| Nurtured Heart ApproachBased on three stands designed to reduce negative reactivity from parents/guardians, increase positive interactions, and set firm, clear limits. | Behavioural | Control Group, NHA Group |
Primary outcome
Inattention
Time frame: Six-week change from pre-intervention inattention to post-intervention inattention.
Parent reported measure called Conners-3 Parent Short Form. Raw scores are converted into standardized T-scores using age- and sex-specific conversion standards. The minimum T-score is 40 and the maximum is 90. The six content subscales are inattention, hyperactivity/impulsivity, learning problems, executive function, defiance/aggression, and peer relations. Higher T-scores are worse.
Hyperactivity/Impulsivity
Time frame: Six-week change from pre-intervention hyperactivity/impulsivity to post-intervention hyperactivity/impulsivity.
Parent reported measure called Conners-3 Parent Short Form. Raw scores are converted into standardized T-scores using age- and sex-specific conversion standards. The minimum T-score is 40 and the maximum is 90. The six content subscales are inattention, hyperactivity/impulsivity, learning problems, executive function, defiance/aggression, and peer relations. Higher T-scores are worse.
2 secondary outcomes
Parental Stress
Time frame: Six-week change from pre-intervention parental stress to post-intervention parental stress.
Parenting Competency
Time frame: Six-week change from pre-intervention parenting competency to post-intervention parenting competency.
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 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurtured Heart Approach in people with Attention Deficit Hyperactivity Disorder, run by University of Arizona 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 3 inclusion and 1 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 22 Dec 2025. 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?
Inattention (time frame: Six-week change from pre-intervention inattention to post-intervention inattention.). 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?
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 22 Dec 2025.