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

Alcohol Drinking Clinical Trial

— e-Parenting  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718508
• Other study ID #: 1R21AA024185-01
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: April 10, 2018
• Start date: September 2015
• Est. completion date: February 2018

Study information

• Verified date: April 2018
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Parenting
• Underage Drinking

Intervention

Behavioral:
• eParenting
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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Michael J. Mello, MD, MPH	Connecticut Children's Medical Center, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 months
Secondary	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.	Up to 6 months
Secondary	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).	Up to 6 months
Secondary	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).	Up to 6 months