Prevention of Drug Abuse RiskNCT00538252
Parental Involvement and Children's Extra-Familial Contexts
An observational study of Prevention of Drug Abuse Risk, run by University of Pittsburgh at 1 site in United States.
Trial summary
Parental involvement has been shown to be a robust predictor of child conduct problems (CP) and drug use risk in childhood and adolescence, but relatively little attention has been paid to the role of parental involvement in relation to child problem behavior during the transition to school-age, when children are… Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Prevention of Drug Abuse Risk
- How many people
- 731 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Apr 2012
- 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 2 to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: 731 toddlers and their families followed from age 2 to 9 recruited on the basis of low socioeconomic status, and the presence of family (e.g., parental depression, drug use) and child (disruptive behavior) risk.
Who may be able to join
- Previously enrolled sample of 731 children recruited on the basis of prior screening for socioeconomic, family, and child risk factors at age 2
Who cannot join
- All children and families needed to have a child 2-3 years of age with multiple socioeconomic, family, and child risk factors.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Parental Involvement, Extra-Familial Contexts and Prevention of Drug Use Risk
Parental involvement has been shown to be a robust predictor of child conduct problems (CP) and drug use risk in childhood and adolescence, but relatively little attention has been paid to the role of parental involvement in relation to child problem behavior during the transition to school-age, when children are spending more time in school, after-care settings, and in the neighborhood. Concomitantly, as children transition from preschool to school-age, there is evidence to suggest that the quality and organization of schools, after-school care, and neighborhoods play an increasingly important role in the emergence of children's CP and drug use risk. Specifically, we will address: 1) the extent to which the quality of school environments, after-school care, and neighborhoods are associated with the emergence of CP during the early school-age period; 2) how parental involvement in the toddler and preschool period may be associated with parental involvement and monitoring in extra-familial contexts in the early school-age years; 3) how parental involvement in schools, after-care, and the neighborhood, may moderate relationships between extra-familial factors and children's CP; and 4) whether a parenting intervention can increase parental involvement in school, after-care, and neighborhood contexts and decrease risk of children's subsequent CP. These issues will be tested with an existing sample of 731 ethnically-diverse children from urban, suburban, and rural sites. As all families in the study were recruited based on the presence of sociodemographic, family, and child risk factors, the cohort of children are at high risk for displaying a persistent trajectory of clinically-meaningful CP and drug use risk. Thus, the study has the potential to fill a much-needed void on associations between extra-familial contexts and risk for early-starting CP and later problem behavior during the early school-age years. Equally critical, the study can provide data on the potential moderating influence of involved parenting, its malleability for families facing multiple adversities, and whether family-based interventions can make a difference for children facing multiple adversities.
- Conditions
- Prevention of Drug Abuse Risk
- Keywords
- drug use, antisocial behavior, early intervention, prevention
- Medical subject headings
- Antisocial Personality Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Achenbach Teacher Report Form
Teachers reports on over 100 items covering children's externalizing and internalizing problem behavior
Measured: collected annually when children are ages 7 to 9 years old
Secondary outcomes (1)
Parental Monitoring Inventory
Both children and parents report on the amount and quality of monitoring parents provide regarding their children's after-school activities
Measured: Collected annually when children are ages 7 to 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of Drug Abuse RiskStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Daniel Shaw, University of Pittsburgh
- Investigators
- Daniel S. Shaw, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538252
- Sponsor's protocol ID
- involvementincontext
- Other IDs
- R01DA023245, DA023245
- Status last verified
- Dec 2013
- First submitted
- 1 Oct 2007
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tein JY, Wang FL, Oro V, Kim H, Shaw D, Wilson M, Lemery-Chalfant K. The role of early intervention for adolescent mental health and polydrug use: Cascading mediation through childhood growth in the general psychopathology (p) factor. Dev Psychol. 2023 Aug;59(8):1484-1495. doi: 10.1037/dev0001543. Epub 2023 May 18.
PubMed 37199932
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Involvement, Extra-Familial Contexts and Prevention of Drug Use Risk
- ClinicalTrials.gov ID
- NCT00538252
- Acronym / sponsor ID
- involvementincontext
- Conditions
- Prevention of Drug Abuse Risk
- Keywords
- drug use, antisocial behavior, early intervention, prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 2 Oct 2007 (estimated)
- 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.
Parental involvement has been shown to be a robust predictor of child conduct problems (CP) and drug use risk in childhood and adolescence, but relatively little attention has been paid to the role of parental involvement in relation to child problem behavior during the transition to school-age, when children are spending more time in school, after-care settings, and in the neighborhood. Concomitantly, as children transition from preschool to school-age, there is evidence to suggest that the quality and organization of schools, after-school care, and neighborhoods play an increasingly important role in the emergence of children's CP and drug use risk. Specifically, we will address: 1) the extent to which the quality of school environments, after-school care, and neighborhoods are associated with the emergence of CP during the early school-age period; 2) how parental involvement in the toddler and preschool period may be associated with parental involvement and monitoring in extra-familial contexts in the early school-age years; 3) how parental involvement in schools, after-care, and the neighborhood, may moderate relationships between extra-familial factors and children's CP; and 4) whether a parenting intervention can increase parental involvement in school, after-care, and neighborhood contexts and decrease risk of children's subsequent CP. These issues will be tested with an existing sample of 731 ethnically-diverse children from urban, suburban, and rural sites. As all families in the study were recruited based on the presence of sociodemographic, family, and child risk factors, the cohort of children are at high risk for displaying a persistent trajectory of clinically-meaningful CP and drug use risk. Thus, the study has the potential to fill a much-needed void on associations between extra-familial contexts and risk for early-starting CP and later problem behavior during the early school-age years. Equally critical, the study can provide data on the potential moderating influence of involved parenting, its malleability for families facing multiple adversities, and whether family-based interventions can make a difference for children facing multiple adversities.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 731 toddlers and their families followed from age 2 to 9 recruited on the basis of low socioeconomic status, and the presence of family (e.g., parental depression, drug use) and child (disruptive behavior) risk.
Key inclusion criteria (1 listed)
- Previously enrolled sample of 731 children recruited on the basis of prior screening for socioeconomic, family, and child risk factors at age 2
Key exclusion criteria (1 listed)
- All children and families needed to have a child 2-3 years of age with multiple socioeconomic, family, and child risk factors.
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
Achenbach Teacher Report Form
Time frame: collected annually when children are ages 7 to 9 years old
Teachers reports on over 100 items covering children's externalizing and internalizing problem behavior
1 secondary outcome
Parental Monitoring Inventory
Time frame: Collected annually when children are ages 7 to 9
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 11 Dec 2013.
- Derived from this study: PubMed 37199932Tein JY, Wang FL, Oro V, Kim H, Shaw D, Wilson M, Lemery-Chalfant K. The role of early intervention for adolescent mental health and polydrug use: Cascading mediation through childhood growth in the general psychopathology (p) factor. Dev Psychol. 2023 Aug;59(8):1484-1495. doi: 10.1037/dev0001543. Epub 2023 May 18.
Related trials for Prevention of Drug Abuse Risk
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
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.
Daniel S. Shaw, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Drug Abuse Risk, run by University of Pittsburgh at 1 site in United States.
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 1 inclusion and 1 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Achenbach Teacher Report Form (time frame: collected annually when children are ages 7 to 9 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538252, which also lists 1 linked publication.
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 11 Dec 2013.