- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02718508
An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use (e-Parenting)
April 10, 2018 updated by: Michael J. Mello, MD, MPH
The objective of this trial is to test feasibility and acceptability of an e-parenting skills intervention with parents of injured adolescent alcohol users (12-17 years old) as compared to standard care at three pediatric trauma centers.
To examine these questions, the investigators will randomly assign adolescent and parent dyads (up to 75) to one of two groups.
One group will continue to receive the institutional standard care of a brief alcohol intervention delivered by clinical staff to the adolescent with no parenting skills intervention.
The second group will continue to receive the same institutional standard care plus the parent will receive an e-parenting skills intervention consisting of: the online parent training program, Parenting Wisely(PW), plus text messaging and a web-based message board.
Study participants will be injured adolescents, 12-17 years old, admitted to the inpatient service of the trauma center, and with a positive CRAFFT (mnemonic acronym of first letters of key words in the screening tool) screen for alcohol use.
Adolescents' alcohol use will be measured at study enrollment and at 3 and 6 months after discharge.
Adolescents' alcohol related negative consequences will be measured at study enrollment for the 6 months prior to hospitalization and again at 6 months after hospital discharge.
Parenting skills will also be assessed at 3 and 6 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study seeks to test the feasibility and acceptability of an e-parenting skills intervention at three pediatric trauma centers.
The investigators will randomize up to 75 dyads of injured adolescents (12-17 years old) who screen positive for alcohol use and their parent to receive either standard trauma center care (a brief intervention with the adolescent) or standard trauma center care (a brief intervention with the adolescent) plus an e-parenting skills intervention consisting of a computerized intervention for parent skill building, a series of text messages and a web-based message board.
The primary aim of this study is to determine the feasibility and acceptability of conducting the e-parenting intervention protocol across three pediatric trauma centers in preparation for a larger fully power trial.
The central hypothesis for our future fully powered randomized control trial is that adolescents whose parents receive the e-parenting skills intervention will decrease their alcohol use and alcohol-related negative consequences over the 6 months following the intervention more than adolescents who receive only standard trauma center care.
Therefore, a secondary aim of this proposal is to calculate a preliminary effect size that could be used, along with other relevant data, such as the acceptability data and findings in the literature, to calculate sample size in a future fully powered randomized control trial.
The investigators will also examine adolescent's conjoint use of marijuana.
This project advances translational research in collecting preliminary data on an e-parenting skills intervention that can be easily adopted with high fidelity across pediatric trauma centers.
Its findings have the potential to directly impact best clinical practices for intervening with alcohol using injured adolescents
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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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
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adolescents, age 12-17, admitted to the trauma service
- medically stable
- a positive CRAFFT screen or lab screen for alcohol use or drug use
- ability to assent to study and have one parent consent
- adolescent and parent are English speaking
Exclusion Criteria:
- the adolescent is cognitively or emotionally unable to participate as determined by a trauma clinician
- the adolescent is suspected by the clinical staff of being a victim of child abuse (and referred to child protective services)
- the adolescent is being evaluated following a suicide attempt
- prior to admission, the adolescent is being treated for an alcohol or drug dependency
- adolescent is currently incarcerated
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Care
All enrolled adolescents will continue to receive standard trauma center care, a brief intervention during their hospitalization by a trauma center social worker which is required by institutional policy.
|
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Experimental: Standard Care plus e-Parenting Group
The second group will continue to receive the same institutional standard care plus the parent will receive an e-parenting skills intervention consisting of: the online parent training program, Parenting Wisely (PW), plus text messaging and a web-based message board.
|
The second group will continue to receive the same institutional standard care plus the parent will receive an e-parenting skills intervention consisting of: the online parent training program, Parenting Wisely (PW), plus text messaging and a web-based message board.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and Acceptability of an e-Parenting Skills Intervention
Time Frame: Up to 3 months
|
Feasibility will be measured by parent data (number of Parenting Wisely logins and activities completed).
Acceptability will be measured by the Systems Usability Scale (SUS) which rates parent ease of use of the program and the Consumer Satisfaction Questionnaire (CSQ) which rates level of parent satisfaction with treatment delivery and ability to manage child's behavior.
|
Up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects on Alcohol Use as assessed by Adolescent Drug Questionnaire (ADQ).
Time Frame: Up to 6 months
|
Alcohol use will be measured by Adolescent Drug Questionnaire (number of drinking days and heavy drinking days in the past 3 months) among teen participants.
|
Up to 6 months
|
Effects on Drug use as assessed by Drug Use Questionnaire (DUQ).
Time Frame: Up to 6 months
|
Drug use will be measured by Drug Use Questionnaire (number of days in the past 3 months teen participants used nicotine, marijuana, cocaine and other drugs).
|
Up to 6 months
|
Effects on Alcohol and Drug Related Problems as assessed by Add Health measures.
Time Frame: Up to 6 months
|
Alcohol and drug related problems will be measured by the 9 questions from the Add Health survey (frequency of psychosocial and health consequences associated with alcohol and drug use over the prior 3 month period).
|
Up to 6 months
|
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 (Actual)
September 1, 2015
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
March 2, 2016
First Submitted That Met QC Criteria
March 23, 2016
First Posted (Estimate)
March 24, 2016
Study Record Updates
Last Update Posted (Actual)
April 11, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21AA024185-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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