NCT04086979

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

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

September 1, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

September 6, 2019

Last Update Submit

September 10, 2019

Conditions

Keywords

friendship

Outcome Measures

Primary Outcomes (4)

  • Change in Positive and Negative Friendship Quality - Questionnaires

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

    change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

  • Change in Positive and Negative Friendship Quality - Questionnaires

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

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

  • Change in Positive and Negative Friendship Quality - Observations

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

    change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

  • Change in Positive and Negative Friendship Quality - Observations

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

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

Secondary Outcomes (6)

  • Change in Positive and Negative Friendship Behaviors- Questionnaires

    change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

  • Change in Positive and Negative Friendship Behaviors- Questionnaires

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

  • Change in Positive and Negative Friendship Behaviors- Questionnaires

    change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

  • Change in Positive and Negative Friendship Behaviors- Questionnaires

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

  • Change in Positive and Negative Friendship Behaviors- Observations

    change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)

  • +1 more secondary outcomes

Study Arms (2)

Parental Friendship Coaching (PFC)

EXPERIMENTAL
Behavioral: Parental Friendship Coaching

Coping with ADHD through Relationships and Education (CARE)

ACTIVE COMPARATOR
Behavioral: Coping with ADHD through Relationships and Education

Interventions

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.

Parental Friendship Coaching (PFC)

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.

Coping with ADHD through Relationships and Education (CARE)

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Coping SkillsEducational Status

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Amori Mikami, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Sebastien Normand, PhD

    Université du Québec en Outaouais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two interventions: Parental Friendship Coaching (PFC) or Coping with ADHD through Relationships and Education (CARE)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 12, 2019

Study Start

September 1, 2013

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share