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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Testing the Efficacy of the Nurtured Heart Approach: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685279
• Other study ID #: 1707672022
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
• Nurtured Heart Approach
Based on three stands designed to reduce negative reactivity from parents/guardians, increase positive interactions, and set firm, clear limits.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	Six-week change from pre-intervention parental stress to post-intervention parental stress.
Secondary	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.	Six-week change from pre-intervention parenting competency to post-intervention parenting competency.