Substance UseTIPSNCT03710720
Trauma Informed Prevention for Substance Use and Risky Sex
A study testing TIPS app and Trauma Focused-Cognitive Behavioral Therapy in people with Substance Use and HIV/AIDS, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this research study is to determine the usefulness of the TIPS iPad app in the treatment of adolescent patients who qualify for Trauma Focused-Cognitive Behavioral Therapy (TF-CBT). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Substance Use, HIV/AIDS
- What is being tested?
- TIPS app and Trauma Focused-Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 23 Dec 2020
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have experienced at least one traumatic event
Who cannot join
- Adolescents exhibiting psychotic symptoms
- Significant cognitive disability
- PDD
- Active suicidal or homicidal ideations
- Meets criteria for a DSM-5 moderate or severe substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Mentorship and Research in HIV and Addiction Prevention Among Traumatized Youth
The purpose of this research study is to determine the usefulness of the TIPS iPad app in the treatment of adolescent patients who qualify for Trauma Focused-Cognitive Behavioral Therapy (TF-CBT).
Read the detailed description
The primary goal of this study is to conduct a feasibility test of the delivery of the TIPS app during implementation of TF-CBT in comparison to TF-CBT as it is usually administered, as well as feasibility of methods that would be utilized in a larger scale evaluation of the toolkit. Clients will be randomly assigned to one of the two conditions, TF-CBT plus the TIPS app or TF-CBT as usual. Study duration is six months and includes four total assessments, which will be completed by hand. These assessments will occur over the 12-16 weeks of TF-CBT that clients would receive whether they choose to participate in the study or not. Participation in this study may broaden your child's treatment to target prevention of risk behaviors, but that cannot be guaranteed.
- Conditions
- Substance Use, HIV/AIDS
- Being tested
- TIPS app, Trauma Focused-Cognitive Behavioral Therapy
- Keywords
- Traumatic stress, substance use prevention, HIV prevention, adolescents
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPS appBehavioural
Psycho-educational electronic application
Trauma Focused-Cognitive Behavioral TherapyBehavioural
Also called TF-CBT
Effective form of trauma therapy for adolescents
| Study group | Role | What they receive |
|---|---|---|
| TF-CBT plus TIPS app | Experimental | Not described Receives: Behavioral: TIPS app; Behavioral: Trauma Focused-Cognitive Behavioral Therapy |
| TF-CBT | Active comparator | Not described Receives: Behavioral: Trauma Focused-Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risky Sexual Behaviors Scale
The Risky Sexual Behaviors Scale (RSBS) is a validated measure that was originally created to gain more insight on the behaviors of a population of homeless adolescents. The scale measures increased risk of STDs through four major scale items. The RSBS uses a five-point Likert scale that targets caregiver involvement in discussions surrounding sexual behaviors with the option for least involved being "never" (score of 1) and the greatest involved being "always" (score of 5). The scale also includes fill-in-the-blank questions that gauge the number of "times" an adolescent has engaged in a specific behavior in the past 30 days and the past 90 days. Higher scores are indicative of higher rates of risky sexual behaviors.
Measured: Pretreatment to 6 month follow-up
Secondary outcomes (7)
Family Environment Scale
The Family Environment Scale (FES) is a validated measure that is made up of 26 "true or false" questions that target different interactions that commonly occur within families. We are using two validated subscales from this measure, family conflict and family cohesion. Higher scores on the family conflict subscale are indicative of greater rates of family conflict. Higher rates on the family cohesion subscale are indicative of higher rates of family cohesion. The measure aims to detect an increase in positive family environment over time.
Measured: Pretreatment to 6 month follow-up
Bad Friends Subscale of the Pittsburgh Youth Study
The Bad Friends Subscale of the Pittsburg Youth Study (Youth-Friends Scale) is a validated measure made up of eight questions (both fill-in-the-blank and yes/no) that aim to detect caregiver approval of adolescent peer groups and whether caregiver opinions are considered in future peer interactions. The scale aims to detect a decrease in negative peers over time. Answers are qualitative in nature. In general, the rater looks for themes in regards to whether the youth spends time with negative peers (that the caregiver does not approve of).
Measured: Pretreatment to 6 month follow-up
Alabama Parenting Questionnaire
The Alabama Parenting Questionnaire (APQ) is a validated measure consisting of questions that look into family interactions and, more specifically, interactions between youth and caregiver. The scale is scored on a five-point Likert scale that ranges from "never" (score of 1) to "always" (score of 5) when looking at how often certain behaviors occur within the home. High scores on the positive parenting subscale and low scores on the poor monitoring/supervision, inconsistent discipline, and corporal punishment subscales are indicative of positive parenting.
Measured: Pretreatment to 6 month follow-up
UCLA PTSD Index DSM-V
The UCLA Post Traumatic Stress Disorder Index DSM-IV (UCLA PTSD Index DSM-IV) is a validated, subjective measure that consists of 23 yes or no questions regarding the occurrence of different traumas or losses that may happen during a child's life. Each question is followed up with details of the trauma that occurred and more extensive questioning for the trauma experienced that is still most bothersome in the present day. These follow-up questions gauge symptoms of PTSD on a five-point Likert scale that ranges from "none" (score of 0, no days has this symptom occurred in the last month) to "most" (score of 4, symptom occurred almost every day in the past month). The most traumatic experience is also followed by several yes/no questions that gauge distress and functional impairment. Higher scores are indicative of higher rates of PTSD symptoms.
Measured: Pretreatment to 6 month follow-up
Children's Depression Inventory
The Children's Depression Inventory (CDI) is a validated measure that consists of 27 multiple choice items that gauge depressive behaviors/symptoms in youth. The items each have three choices that are best described as "Never/Rarely," "Many," or "All" in regards to each behavior in question. Higher scores are indicative of higher rates of depressive symptoms.
Measured: Pretreatment to 6 month follow-up
Timeline Follow Back (TLFM)-Form 90
The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in alcohol use. Higher numbers of substance use are indicative of greater substance use.
Measured: Pretreatment to 6 month follow-up
CRAFFT Screening Tool for Adolescent Substance Abuse
Scores of two or more are indicative of a probable substance use problem.
Measured: Pretreatment to 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start9 Jan 2019
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Carla K Danielson, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710720
- Sponsor's protocol ID
- Pro00041527
- Acronym
- TIPS
- Status last verified
- Dec 2021
- First submitted
- 15 Oct 2018
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Danielson CK, Moreland A, Hahn A, Banks D, Ruggiero KJ. Development and Usability Testing of an mHealth Tool for Trauma-Informed Prevention of Substance Use, HIV Acquisition, and Risky Sexual Behaviors Among Adolescents: Mixed Methods Study. JMIR Form Res. 2024 Jan 18;8:e52835. doi: 10.2196/52835.
PubMed 38236634
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentorship and Research in HIV and Addiction Prevention Among Traumatized Youth
- ClinicalTrials.gov ID
- NCT03710720
- Acronym / sponsor ID
- TIPS / Pro00041527
- Conditions
- Substance Use, HIV/AIDS
- Keywords
- Traumatic stress, substance use prevention, HIV prevention, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 18 Oct 2018 (actual)
- 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 research study is to determine the usefulness of the TIPS iPad app in the treatment of adolescent patients who qualify for Trauma Focused-Cognitive Behavioral Therapy (TF-CBT).
Detailed description
The primary goal of this study is to conduct a feasibility test of the delivery of the TIPS app during implementation of TF-CBT in comparison to TF-CBT as it is usually administered, as well as feasibility of methods that would be utilized in a larger scale evaluation of the toolkit. Clients will be randomly assigned to one of the two conditions, TF-CBT plus the TIPS app or TF-CBT as usual. Study duration is six months and includes four total assessments, which will be completed by hand. These assessments will occur over the 12-16 weeks of TF-CBT that clients would receive whether they choose to participate in the study or not. Participation in this study may broaden your child's treatment to target prevention of risk behaviors, but that cannot be guaranteed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TF-CBT plus TIPS app | Experimental | Behavioral: TIPS app, Behavioral: Trauma Focused-Cognitive Behavioral Therapy |
| TF-CBT | Active comparator | Behavioral: Trauma Focused-Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Have experienced at least one traumatic event
Key exclusion criteria (5 listed)
- Adolescents exhibiting psychotic symptoms
- Significant cognitive disability
- PDD
- Active suicidal or homicidal ideations
- Meets criteria for a DSM-5 moderate or severe substance use disorder
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 |
|---|---|---|
| TIPS appPsycho-educational electronic application | Behavioural | TF-CBT plus TIPS app |
| Trauma Focused-Cognitive Behavioral TherapyAlso: TF-CBTEffective form of trauma therapy for adolescents | Behavioural | TF-CBT, TF-CBT plus TIPS app |
Primary outcome
Risky Sexual Behaviors Scale
Time frame: Pretreatment to 6 month follow-up
The Risky Sexual Behaviors Scale (RSBS) is a validated measure that was originally created to gain more insight on the behaviors of a population of homeless adolescents. The scale measures increased risk of STDs through four major scale items. The RSBS uses a five-point Likert scale that targets caregiver involvement in discussions surrounding sexual behaviors with the option for least involved being "never" (score of 1) and the greatest involved being "always" (score of 5). The scale also includes fill-in-the-blank questions that gauge the number of "times" an adolescent has engaged in a specific behavior in the past 30 days and the past 90 days. Higher scores are indicative of higher rates of risky sexual behaviors.
7 secondary outcomes
Family Environment Scale
Time frame: Pretreatment to 6 month follow-up
Bad Friends Subscale of the Pittsburgh Youth Study
Time frame: Pretreatment to 6 month follow-up
Alabama Parenting Questionnaire
Time frame: Pretreatment to 6 month follow-up
UCLA PTSD Index DSM-V
Time frame: Pretreatment to 6 month follow-up
Children's Depression Inventory
Time frame: Pretreatment to 6 month follow-up
Timeline Follow Back (TLFM)-Form 90
Time frame: Pretreatment to 6 month follow-up
CRAFFT Screening Tool for Adolescent Substance Abuse
Time frame: Pretreatment to 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Derived from this study: PubMed 38236634Danielson CK, Moreland A, Hahn A, Banks D, Ruggiero KJ. Development and Usability Testing of an mHealth Tool for Trauma-Informed Prevention of Substance Use, HIV Acquisition, and Risky Sexual Behaviors Among Adolescents: Mixed Methods Study. JMIR Form Res. 2024 Jan 18;8:e52835. doi: 10.2196/52835.
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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.
Carla K Danielson, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPS app and Trauma Focused-Cognitive Behavioral Therapy in people with Substance Use and HIV/AIDS, run by Medical University of South Carolina 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 13 Dec 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Risky Sexual Behaviors Scale (time frame: Pretreatment to 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03710720, which also lists 1 linked publication.
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 13 Dec 2021.