## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 1707672022
#### Organization
**Class:** OTHER
**Full Name:** University of Arizona
### Status Module
#### Completion Date
**Date:** 2018-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-09-26

**Type:** ACTUAL

**Last Update Submit Date:** 2018-09-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-06-30

**Type:** ACTUAL

#### Start Date
**Date:** 2017-08-14

**Type:** ACTUAL

**Status Verified Date:** 2018-09

#### Study First Post Date
**Date:** 2018-09-26
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-28
**Study First Submit QC Date:** 2018-09-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Arizona

#### Responsible Party

**Investigator Affiliation:** University of Arizona

**Investigator Full Name:** Velia Nuno

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Attention Deficit Hyperactivity Disorder

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 104

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: Nurtured Heart Approach

**Label:** NHA Group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Nurtured Heart Approach

**Label:** Control Group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group

- NHA Group

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

**Name:** Nurtured Heart Approach

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Inattention

**Time Frame:** Six-week change from pre-intervention inattention to post-intervention 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.

**Measure:** Hyperactivity/Impulsivity

**Time Frame:** Six-week change from pre-intervention hyperactivity/impulsivity to post-intervention hyperactivity/impulsivity.

#### Secondary Outcomes

**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.

**Measure:** Parental Stress

**Time Frame:** Six-week change from pre-intervention parental stress to post-intervention parental stress.

**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.

**Measure:** Parenting Competency

**Time Frame:** Six-week change from pre-intervention parenting competency to post-intervention parenting competency.

### Eligibility Module

**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

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tucson

**Country:** United States

**Facility:** University of Arizona

**State:** Arizona

**Zip:** 85724

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019958

- Term: Attention Deficit and Disruptive Behavior Disorders

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4594

- Name: Attention Deficit Disorder with Hyperactivity

- Relevance: HIGH

- As Found: Attention Deficit Hyperactivity Disorder

- ID: M9999

- Name: Hyperkinesis

- Relevance: LOW

- As Found: Unknown

- ID: M21830

- Name: Attention Deficit and Disruptive Behavior Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001289

- Term: Attention Deficit Disorder with Hyperactivity

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T206

- Name: Lemon Balm

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
