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PURPOSE: A Social Media Intervention for Parent Support

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ClinicalTrials.gov Identifier: NCT02629068
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marya Schulte, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE November 30, 2015
First Posted Date  ICMJE December 11, 2015
Last Update Posted Date October 31, 2017
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
Adolescent Treatment History and Parental Engagement Questionnaire [ Time Frame: 8 weeks ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
  • Adolescent Treatment History and Parental Engagement Questionnaire [ Time Frame: 8 weeks ]
    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).
  • Treatment Effectiveness Assessment [ Time Frame: 8 weeks ]
    The TEA collects quantitative and qualitative data on patient perceptions of improvement since starting treatment within four domains: substance use, health, lifestyle, and community. Parents will report on their child's progress (baseline and follow-up)
Change History Complete list of historical versions of study NCT02629068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
  • Perceived Stigma of Addiction Scale [ Time Frame: 8 weeks ]
    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)
  • Parental Monitoring Questionnaire [ Time Frame: 8 weeks ]
    Relationship and disclosure constructs will be used from Stattin and Kerr's (2000) questionnaire of parental monitoring (baseline and follow-up)
  • Satisfaction and Usability Questionnaire [ Time Frame: 8 weeks ]
    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).
  • K-10 Scale of Psychological Distress [ Time Frame: 8 weeks ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PURPOSE: A Social Media Intervention for Parent Support
Official Title  ICMJE Parents United With Responsive Parents for Online Support and Education PURPOSE: A Social Media Intervention for Parent Support
Brief 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.
Detailed 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance Use Disorders
  • Parenting
Intervention  ICMJE 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

Study Arms  ICMJE
  • Experimental: PURPOSE
    Parents in the PURPOSE group will join a "secret" Facebook group for 2 months. Groups will be lead by 2 peer leaders and include 20 parent participants.
    Intervention: Behavioral: PURPOSE
  • No Intervention: Treatment as Usual (TAU)
    Treatment as Usual parents will be contacted after 8 weeks to complete follow-up interview. Will not receive PURPOSE intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2015)
128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Annemarie Kelleghan 310-983-3604 akelleghan@ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02629068
Other Study ID Numbers  ICMJE R21DA039459( U.S. NIH Grant/Contract )
R21DA039459 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marya Schulte, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Marya Schulte, Ph.D. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP