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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parental Friendship Coaching (PFC)
Behavioral: Parental Friendship Coaching
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)
Behavioral: Coping with ADHD through Relationships and Education
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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