Substance Use DisordersNCT02629068
PURPOSE: A Social Media Intervention for Parent Support
A study testing PURPOSE in people with Substance Use Disorders and Parenting, run by University of California, Los Angeles at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Parenting
- What is being tested?
- PURPOSE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025
About this study
Official title: Parents United With Responsive Parents for Online Support and Education PURPOSE: A Social Media Intervention for Parent Support
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.
Read the 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).
- Conditions
- Substance Use Disorders, Parenting
- Being tested
- PURPOSE
- Keywords
- Adolescent, Social Support, Social Media, Parents, Shame, Stigma
- Medical subject headings
- Substance-Related Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PURPOSEBehavioural
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 group | Role | What they receive |
|---|---|---|
| PURPOSE | Experimental | 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. Receives: Behavioral: PURPOSE |
| Treatment as Usual (TAU) | No intervention | Treatment as Usual parents will be contacted after 8 weeks to complete follow-up interview. Will not receive PURPOSE intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (4)
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)
Measured: 8 weeks
Parental Monitoring Questionnaire
Relationship and disclosure constructs will be used from Stattin and Kerr's (2000) questionnaire of parental monitoring (baseline and follow-up)
Measured: 8 weeks
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).
Measured: 8 weeks
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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startOct 2016
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: No participants were enrolled in the pilot phase of the study due to lack of interest from parents. Completion dates reflect the end of funding for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Marya Schulte, University of California, Los Angeles
- Investigators
- Marya Schulte, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629068
- Sponsor's protocol ID
- R21DA039459
- Other IDs
- R21DA039459
- Status last verified
- Apr 2019
- First submitted
- 30 Nov 2015
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents United With Responsive Parents for Online Support and Education PURPOSE: A Social Media Intervention for Parent Support
- ClinicalTrials.gov ID
- NCT02629068
- Acronym / sponsor ID
- R21DA039459
- Conditions
- Substance Use Disorders, Parenting
- Keywords
- Adolescent, Social Support, Social Media, Parents, Shame, Stigma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in the pilot phase of the study due to lack of interest from parents. Completion dates reflect the end of funding for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PURPOSE | Experimental | Behavioral: PURPOSEParents 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. |
| Treatment as Usual (TAU) | No intervention | –Treatment as Usual parents will be contacted after 8 weeks to complete follow-up interview. Will not receive PURPOSE intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PURPOSEThe 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 | Behavioural | PURPOSE |
Primary outcome
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).
4 secondary outcomes
Perceived Stigma of Addiction Scale
Time frame: 8 weeks
Parental Monitoring Questionnaire
Time frame: 8 weeks
Satisfaction and Usability Questionnaire
Time frame: 8 weeks
K-10 Scale of Psychological Distress
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Substance Use Disorders
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Active, not recruiting
Closed-loop TBS Targeting rPO for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marya Schulte, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PURPOSE in people with Substance Use Disorders and Parenting, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Treatment History and Parental Engagement Questionnaire (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.