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

NCT02718508 | Completed DMC

• 1 other identifier: 1R21AA024185-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effects on Alcohol Use as assessed by Adolescent Drug Questionnaire (ADQ).

  Up to 6 months

• Effects on Drug use as assessed by Drug Use Questionnaire (DUQ).

  Up to 6 months

• Effects on Alcohol and Drug Related Problems as assessed by Add Health measures.

  Up to 6 months

Study Arms (2)

Standard Care

NO INTERVENTION

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.

Standard Care plus e-Parenting Group

EXPERIMENTAL

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.

Behavioral: eParenting

Interventions

eParenting BEHAVIORAL

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.

Standard Care plus e-Parenting Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael J. Mello, MD, MPH: lead
• Connecticut Children's Medical Center: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Michael J Mello, MD, MPH

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Injury Prevention Center

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 24, 2016
• Study Start: September 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: February 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)