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An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use (e-Parenting)

Primary Purpose

Parenting, Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eParenting
Sponsored by
Michael J. Mello, MD, MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parenting

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Standard Care plus e-Parenting Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility and Acceptability of an e-Parenting Skills Intervention
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.

Secondary Outcome Measures

Effects on Alcohol Use as assessed by Adolescent Drug Questionnaire (ADQ).
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.
Effects on Drug use as assessed by Drug Use Questionnaire (DUQ).
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).
Effects on Alcohol and Drug Related Problems as assessed by Add Health measures.
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).

Full Information

First Posted
March 2, 2016
Last Updated
April 10, 2018
Sponsor
Michael J. Mello, MD, MPH
Collaborators
Connecticut Children's Medical Center, University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02718508
Brief Title
An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use
Acronym
e-Parenting
Official Title
An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael J. Mello, MD, MPH
Collaborators
Connecticut Children's Medical Center, University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Alcohol Drinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Standard Care plus e-Parenting Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
eParenting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and Acceptability of an e-Parenting Skills Intervention
Description
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.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Effects on Alcohol Use as assessed by Adolescent Drug Questionnaire (ADQ).
Description
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.
Time Frame
Up to 6 months
Title
Effects on Drug use as assessed by Drug Use Questionnaire (DUQ).
Description
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).
Time Frame
Up to 6 months
Title
Effects on Alcohol and Drug Related Problems as assessed by Add Health measures.
Description
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).
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Mello, MD, MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use

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