## Protocol Section
### Identification Module
**NCT ID:** NCT04086979

**Brief Title:** Parents as Friendship Coaches for Children With ADHD

**Official Title:** Parents as Friendship Coaches for Children With Attention-Deficit/Hyperactivity Disorder

#### Organization Study ID Info
**ID:** 285413
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2018-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-09-12

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2013-09-01

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2019-09-12
**Type:** ACTUAL
**Study First Submit Date:** 2019-09-06
**Study First Submit QC Date:** 2019-09-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of British Columbia

#### Responsible Party

**Investigator Affiliation:** University of British Columbia

**Investigator Full Name:** Amori Yee Mikami

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Many children with Attention-Deficit/Hyperactivity Disorder (ADHD) have problems with making and keeping friends. The current study compared the efficacy of two 10-week behavioral interventions for improving the friendships of children with this disorder. Participants were children ages 6-11 with ADHD and their families, who were experiencing friendship problems. Outcome measures assessed friendship quality and friendship behaviors at baseline (pre-treatment), post-treatment, and 8-month follow-up.

### Conditions Module

**Conditions:**

- ADHD

**Keywords:**

- friendship

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Participants were randomly assigned to one of two interventions: Parental Friendship Coaching (PFC) or Coping with ADHD through Relationships and Education (CARE)

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Some outcomes were observed by coders unaware of the participant's intervention condition. Other outcomes were reported by participants who were aware of their intervention condition.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 172

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Parental Friendship Coaching

**Label:** Parental Friendship Coaching (PFC)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Coping with ADHD through Relationships and Education

**Label:** Coping with ADHD through Relationships and Education (CARE)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Parental Friendship Coaching (PFC)

**Description:** In this condition, therapists instructed parents in ways to coach their children to display better friendship behaviors using skills teaching, role play, active practice, and homework. This is a 10 week group intervention.

**Name:** Parental Friendship Coaching

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Coping with ADHD through Relationships and Education (CARE)

**Description:** In this condition, the therapist provided parents with psychoeducation about ADHD and friendship difficulties, and encouraged them to apply this information to their child and to support one another with tips about how to address these problems. This is a 10 week group intervention.

**Name:** Coping with ADHD through Relationships and Education

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Measures of positive and negative relationship quality with a friend, as reported by informants (adults, children) on the Friendship Quality Questionnaire

**Measure:** Change in Positive and Negative Friendship Quality - Questionnaires

**Time Frame:** change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

**Description:** Measures of positive and negative relationship quality with a friend, as reported by informants (adults, children) on the Friendship Quality Questionnaire

**Measure:** Change in Positive and Negative Friendship Quality - Questionnaires

**Time Frame:** change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)

**Description:** Measures of positive and negative relationship quality with a friend, as observed in a lab-based interaction

**Measure:** Change in Positive and Negative Friendship Quality - Observations

**Time Frame:** change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

**Description:** Measures of positive and negative relationship quality with a friend, as observed in a lab-based interaction

**Measure:** Change in Positive and Negative Friendship Quality - Observations

**Time Frame:** change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)

#### Secondary Outcomes

**Description:** Measures of positive and negative behaviors with a friend, as reported by parents on the Quality of Play Questionnaire

**Measure:** Change in Positive and Negative Friendship Behaviors- Questionnaires

**Time Frame:** change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

**Description:** Measures of positive and negative behaviors with a friend, as reported by parents on the Quality of Play Questionnaire

**Measure:** Change in Positive and Negative Friendship Behaviors- Questionnaires

**Time Frame:** change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)

**Description:** Measures of positive and negative behaviors with a friend, as reported by parents and teachers on the Social Skills Informant System

**Measure:** Change in Positive and Negative Friendship Behaviors- Questionnaires

**Time Frame:** change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

**Description:** Measures of positive and negative behaviors with a friend, as reported by parents and teachers on the Social Skills Informant System

**Measure:** Change in Positive and Negative Friendship Behaviors- Questionnaires

**Time Frame:** change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)

**Description:** Measures of positive and negative behaviors with a friend, as observed in a lab-based interaction

**Measure:** Change in Positive and Negative Friendship Behaviors- Observations

**Time Frame:** change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

**Description:** Measures of positive and negative behaviors with a friend, as observed in a lab-based interaction

**Measure:** Change in Positive and Negative Friendship Behaviors- Observations

**Time Frame:** change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Children who meet diagnostic criteria for ADHD
* Children who are have peer relationship problems

Exclusion Criteria:

* Children with autism spectrum disorder, psychosis, or active suicidality (requires other interventions
* Children with intellectual disability (may not benefit from the interventions offered)
* Children who are not on a stable dose of medication (this treatment may affect outcome measures)
* Children who are receiving other behavioral treatment or treatment for social problems (these other treatments may affect outcome measures).

**Maximum Age:** 11 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** University of British Columbia

**Name:** Amori Mikami, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Université du Québec en Outaouais

**Name:** Sebastien Normand, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### 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: LOW

- As Found: Unknown

- ID: M9999

- Name: Hyperkinesis

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
