NCT03685279

Brief 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). Participants are randomized into the immediate (NHA) or delayed (Control) group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

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

August 14, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
Last Updated

December 22, 2025

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

August 28, 2018

Last Update Submit

December 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Six-week change from pre-intervention hyperactivity/impulsivity to post-intervention hyperactivity/impulsivity.

Secondary Outcomes (2)

  • Parental Stress

    Six-week change from pre-intervention parental stress to post-intervention parental stress.

  • Parenting Competency

    Six-week change from pre-intervention parenting competency to post-intervention parenting competency.

Study Arms (2)

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.

Behavioral: Nurtured Heart Approach

Control Group

OTHER

The Control Group received the same intervention after the collection of NHA Group post-intervention surveys.

Behavioral: Nurtured Heart Approach

Interventions

Based on three stands designed to reduce negative reactivity from parents/guardians, increase positive interactions, and set firm, clear limits.

Control GroupNHA Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Child with ADHD, or suspected of ADHD, cannot have a diagnosis of autism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 28, 2018

First Posted

September 26, 2018

Study Start

August 14, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

December 22, 2025

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations