- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03691389
Investigating the Relationship Between Parents and Their Children With ADHD and Conduct Disorder
January 17, 2019 updated by: Yale-NUS College
Investigating the Relationship Between Children With ADHD and Conduct Disorder and Their Parents in Reduction of Symptoms
This study aims to uncover mechanisms of action underlying any long-term change in youth antisocial behavior by considering the role of child and family characteristics as mediators and moderators of change.
The study design is qualitative interviews to be conducted face-to-face with parents of children previously diagnosed with Conduct Disorder and Attention Deficit Hyperactivity Disorder (ADHD) but no longer meet diagnostic criteria.
Questions will be asked to understand participants' parenting experience over time (before, during and after their children's treatment).
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study population consists parents of children who participated in a previous longitudinal study that investigates the effectiveness of omega-3 supplementation and social skills training in treating Conduct Disorder and Attention Deficit Hyperactivity Disorder (ADHD).
The study ended noting that some children no longer meet the criteria of the disorders and based on existing literature, parental interactions may have a role in this phenomenon.
As such, this research proposes to interview parents of these children to understand more.
Description
Inclusion Criteria:
- Parents of children who participated in previous study "Supplements and Social Skills Intervention" conducted by Singapore Institute of Mental Health Child Guidance Clinic.
- Children no longer meet the criteria for Conduct Disorder and ADHD, as measured by Antisocial Process Screening Device (APSD) Callous-Unemotional score of 7 or less, and who do not meet the cut-off for rule-breaking and aggressive behavior determined by Child Behavior Checklist (CBCL). These data were collected from a previous study.
Exclusion Criteria:
- Children who still meet the requirements of Conduct Disorder and ADHD as defined above.
- Parents who did not indicate that they wish to be contacted for follow-up studies.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental style and interactions with children
Time Frame: 1 year
|
Qualitative interview based on a phenomenological analysis will seek to understand from parents before, during, and after the treatment (previous intervention) about their interactions with their children, especially when problematic behavioural issues occur.
All interviews were transcribed verbatim as much as possible, then subjected to a first round of open coding through identification of words, sentences or paragraphs expressing common ideas.
Thereafter, a framework of themes was derived and interview content was organized systematically for analysis.
The transcripts will also be rotated among researchers for the various stages of coding, such that each transcript was coded by at least two different people.
This was to minimize subjectivity in coding and ensure the inter-rater consistency of the codes.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
February 1, 2019
Primary Completion (ANTICIPATED)
March 31, 2019
Study Completion (ANTICIPATED)
March 31, 2019
Study Registration Dates
First Submitted
September 22, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (ACTUAL)
October 1, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 22, 2019
Last Update Submitted That Met QC Criteria
January 17, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YNC-SASSI-Quali
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.