ObservationNCT03691389
Investigating the Relationship Between Parents and Their Children With ADHD and Conduct Disorder
An observational study of Observation, run by Yale-NUS College.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Observation
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 31 Mar 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
- Conditions
- Observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental style and interactions with children
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Feb 2019 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObservationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691389
- Sponsor's protocol ID
- YNC-SASSI-Quali
- Status last verified
- Jan 2019
- First submitted
- 22 Sep 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Children With ADHD and Conduct Disorder and Their Parents in Reduction of Symptoms
- ClinicalTrials.gov ID
- NCT03691389
- Acronym / sponsor ID
- YNC-SASSI-Quali
- Conditions
- Observation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 1 Oct 2018 (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.
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 design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Observation, run by Yale-NUS College.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boyu Lu Zhao (6592321368, lu.zhao.boyu@u.yale-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental style and interactions with children (time frame: 1 year). 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 22 Jan 2019.