- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086979
Parents as Friendship Coaches for Children With ADHD
September 10, 2019 updated by: Amori Yee Mikami, University of British Columbia
Parents as Friendship Coaches for Children With Attention-Deficit/Hyperactivity Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parental Friendship Coaching (PFC)
|
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.
|
|
Active Comparator: Coping with ADHD through Relationships and Education (CARE)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Positive and Negative Friendship Quality - Questionnaires
Time Frame: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
|
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
Time Frame: change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)
|
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
Time Frame: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
|
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
Time Frame: change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Positive and Negative Friendship Behaviors- Questionnaires
Time Frame: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
|
Measures of positive and negative behaviors with a friend, as reported by parents on the Quality of Play Questionnaire
|
change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
|
|
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)
|
Measures of positive and negative behaviors with a friend, as reported by parents on the Quality of Play 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 Behaviors- Questionnaires
Time Frame: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
|
Measures of positive and negative behaviors with a friend, as reported by parents and teachers on the Social Skills Informant System
|
change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
|
|
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)
|
Measures of positive and negative behaviors with a friend, as reported by parents and teachers on the Social Skills Informant System
|
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
Time Frame: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
|
Measures of positive and negative behaviors 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 Behaviors- Observations
Time Frame: change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)
|
Measures of positive and negative behaviors 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amori Mikami, PhD, University of British Columbia
- Principal Investigator: Sebastien Normand, PhD, Universite du Quebec en Outaouais
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2013
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
September 6, 2019
First Submitted That Met QC Criteria
September 10, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 285413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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