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Efficacy of the Nurtured Heart Approach to Reduce ADHD Behaviors in Children

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurtured Heart Approach
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NHA Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 28, 2018
Last Updated
September 24, 2018
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03685279
Brief Title
Efficacy of the Nurtured Heart Approach to Reduce ADHD Behaviors in Children
Official Title
Testing the Efficacy of the Nurtured Heart Approach: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NHA Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
The Control Group received the same intervention after the collection of NHA Group post-intervention surveys.
Intervention Type
Behavioral
Intervention Name(s)
Nurtured Heart Approach
Intervention Description
Based on three stands designed to reduce negative reactivity from parents/guardians, increase positive interactions, and set firm, clear limits.
Primary Outcome Measure Information:
Title
Inattention
Description
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.
Time Frame
Six-week change from pre-intervention inattention to post-intervention inattention.
Title
Hyperactivity/Impulsivity
Description
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.
Time Frame
Six-week change from pre-intervention hyperactivity/impulsivity to post-intervention hyperactivity/impulsivity.
Secondary Outcome Measure Information:
Title
Parental Stress
Description
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.
Time Frame
Six-week change from pre-intervention parental stress to post-intervention parental stress.
Title
Parenting Competency
Description
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.
Time Frame
Six-week change from pre-intervention parenting competency to post-intervention parenting competency.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Child with ADHD, or suspected of ADHD, cannot have a diagnosis of autism
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of the Nurtured Heart Approach to Reduce ADHD Behaviors in Children

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