ADHD Clinical Trial
Official title:
Parents as Friendship Coaches for Children With Attention-Deficit/Hyperactivity Disorder
| NCT number | NCT04086979 |
| Other study ID # | 285413 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 1, 2013 |
| Est. completion date | July 1, 2018 |
| Verified date | September 2019 |
| Source | University of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 172 |
| Est. completion date | July 1, 2018 |
| Est. primary completion date | July 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 11 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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 | 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 | change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline) | |
| Secondary | 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 | change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment) | |
| Secondary | 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 | change from baseline (pre-treatment) to post-treatment (approximately 4 months after baseline) | |
| Secondary | 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 | change from baseline (pre-treatment) to follow-up (approximately 12 months after baseline, and 4 months after post-treatment) | |
| Secondary | Change in Positive and Negative Friendship Behaviors- Observations | 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) | |
| Secondary | Change in Positive and Negative Friendship Behaviors- Observations | 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) |
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