NCT03691389

Brief 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. 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

September 22, 2018

Last Update Submit

January 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2018

First Posted

October 1, 2018

Study Start

February 1, 2019

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

January 22, 2019

Record last verified: 2019-01