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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02629068
Other study ID # R21DA039459
Secondary ID R21DA039459
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date August 2018

Study information

Verified date April 2019
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to develop and test a social media-based (Facebook) intervention that provides support and skills to parents with adolescent children in treatment for substance abuse. The Facebook intervention, PURPOSE, will be 8 weeks long and led by other parents (peer leaders). Peer leaders will go through 2 2-3-hour training sessions and be assessed at the end to confirm their understanding of study protocol and procedures. The study PI will lead 2 short (2-weeks) trial tests of various segments of the intervention to test out content and procedures. Then, a pilot trial with 80 parents, 40 randomized to PURPOSE and 40 randomized to treatment as usual (TAU), will be done to test how useful PURPOSE can be in promoting parents' engagement in their child's treatment and recovery while reducing their own distress and feelings of shame/stigma. Parents will do a phone interview at the start of PURPOSE and again at the end of the 8 weeks.


Description:

This study will take advantage of established peer training techniques to train parents of adolescents who are more experienced to help other parents better engage in services for their adolescent child. This pilot study marks the beginning of our long-term program of research focused on adapting intervention tools for delivery via e-technology platforms as a means for optimizing treatment effectiveness for youth. Thus, the proposed study will contribute to the scientific literature on the role of parental support in adolescent recovery as well as respond to NIDA's call for increased understanding of the feasibility and utility of social media as an option expanding the traditional treatment and face-to-face self-help groups. The proposed study has the following aims:

Aim 1: To develop PURPOSE, a social-media based intervention that provides information and coping tools for parents/guardians of adolescent children with a SUD. The theoretically grounded intervention will be peer-led, and will be developed and refined with feedback from experts, providers, parents, and adolescents.

Aim 2: To determine the feasibility and acceptability of PURPOSE that uses online peer-led intervention delivery. Trial testing will be conducted to iteratively refine content and procedures in order to optimize the engagement and usefulness of the intervention for parents.

Aim 3: To conduct a pilot control trial to provide preliminary data on this intervention so as to determine if social media-based parent support group involvement positively impacts parent outcomes (reduced stigma and distress, improved parent monitoring, and increased engagement in adolescent treatment) and adolescent outcomes (treatment retention and abstinence).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Be the parent/guardian of an adolescent (under age 18) currently receiving out-patient treatment for SUD

- Have an active Facebook and email account

- Be able to read and write English

Exclusion Criteria:

- Any medical and/or psychiatric conditions which would require immediate or ongoing treatment that would make study participation difficult or harmful

- Already participating in an online support group for parents of teens in treatment

Study Design


Intervention

Behavioral:
PURPOSE
The first week of the intervention will focus on welcoming everyone to the facebook group and laying down the ground rules for participation. Each additional week of the intervention will focus on a specific topic to promote discussion and learning of each particular skill; however, questions and discussions on other relevant topics are always welcome and encouraged. Week 1: Welcome Week Week 2: SUD Basics Week 3: Problem of Stigma Week 4: Communication Skills Week 5: Parental Monitoring Week 6: Stress Management Week 7: Family and Valued Directions Week 8: Putting It All Together

Locations

Country Name City State
United States UCLA Integrated Substance Abuse Programs Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adolescent Treatment History and Parental Engagement Questionnaire Parental report of child's treatment status, including enrollment date, primary reason for seeking treatment, and type of facility. All parents will also report on number of informal parent/family support groups (e.g., AlAnon) and formal treatment sessions they have attended (baseline and follow-up). 8 weeks
Secondary Perceived Stigma of Addiction Scale The PSAS is an 8-item self-report questionnaire designed to assess perceptions of the prevalence of stigmatizing beliefs towards individuals with substance use diagnoses and treatment histories (baseline and follow-up) 8 weeks
Secondary Parental Monitoring Questionnaire Relationship and disclosure constructs will be used from Stattin and Kerr's (2000) questionnaire of parental monitoring (baseline and follow-up) 8 weeks
Secondary Satisfaction and Usability Questionnaire Participants will report overall satisfaction and degree to which information provided was deemed applicable and helpful. Likert-scale reports of satisfaction as well as responses to open-ended questions will be collected (PURPOSE intervention parents only and follow-up only). 8 weeks
Secondary K-10 Scale of Psychological Distress The U.S. National Health Survey K-10 is a 10-item screening scale used to assess the degree of non-specific psychological distress over the past 30 days (baseline and follow-up) 8 weeks
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