ADHDNCT04086979
Parents as Friendship Coaches for Children With ADHD
A study testing Parental Friendship Coaching and Coping with ADHD through Relationships and Education in people with ADHD, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- Parental Friendship Coaching and Coping with ADHD through Relationships and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who meet diagnostic criteria for ADHD
- Children who are have peer relationship problems
Who cannot join
- 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).
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- Parental Friendship Coaching, Coping with ADHD through Relationships and Education
- Keywords
- friendship
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Friendship CoachingBehavioural
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.
Coping with ADHD through Relationships and EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parental Friendship Coaching (PFC) | Experimental | Not described Receives: Behavioral: Parental Friendship Coaching |
| Coping with ADHD through Relationships and Education (CARE) | Active comparator | Not described Receives: Behavioral: Coping with ADHD through Relationships and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measures of positive and negative behaviors with a friend, as reported by parents on the Quality of Play Questionnaire
Measured: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
Change in Positive and Negative Friendship Behaviors- Questionnaires
Measures of positive and negative behaviors with a friend, as reported by parents on the Quality of Play Questionnaire
Measured: 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
Measures of positive and negative behaviors with a friend, as reported by parents and teachers on the Social Skills Informant System
Measured: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
Change in Positive and Negative Friendship Behaviors- Questionnaires
Measures of positive and negative behaviors with a friend, as reported by parents and teachers on the Social Skills Informant System
Measured: 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
Measures of positive and negative behaviors with a friend, as observed in a lab-based interaction
Measured: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)
Change in Positive and Negative Friendship Behaviors- Observations
Measures of positive and negative behaviors with a friend, as observed in a lab-based interaction
Measured: change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Sep 2013
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amori Yee Mikami, University of British Columbia
- Investigators
- Amori Mikami, PhD, Principal investigator, University of British ColumbiaSebastien Normand, PhD, Principal investigator, Université du Québec en Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086979
- Sponsor's protocol ID
- 285413
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents as Friendship Coaches for Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT04086979
- Acronym / sponsor ID
- 285413
- Conditions
- ADHD
- Keywords
- friendship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two interventions: Parental Friendship Coaching (PFC) or Coping with ADHD through Relationships and Education (CARE)
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who meet diagnostic criteria for ADHD
- Children who are have peer relationship problems
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental Friendship CoachingIn 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. | Behavioural | Parental Friendship Coaching (PFC) |
| Coping with ADHD through Relationships and EducationIn 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. | Behavioural | Coping with ADHD through Relationships and Education (CARE) |
Primary outcome
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 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 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 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
6 secondary outcomes
Change in Positive and Negative Friendship Behaviors- Questionnaires
Time frame: 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)
Change in Positive and Negative Friendship Behaviors- Questionnaires
Time frame: 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)
Change in Positive and Negative Friendship Behaviors- Observations
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amori Mikami, PhD principal investigator
University of British Columbia
Sebastien Normand, PhD principal investigator
Université du Québec en Outaouais
Questions about this trial
What is this clinical trial studying?
A study testing Parental Friendship Coaching and Coping with ADHD through Relationships and Education in people with ADHD, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Friendship Quality - Questionnaires (time frame: change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.