Substance AbuseNCT01825694
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
A study testing Trauma-focused Substance Abuse Intervention in people with Substance Abuse and Traumatic Stress, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (SAC) in outpatient settings. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Substance Abuse, Traumatic Stress
- What is being tested?
- Trauma-focused Substance Abuse Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2015
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between ages of 13 \& 19;
- meeting DSM IV criteria for substance abuse/dependence and PTSD;
- previously enrolled at recruitment site for at least 2 weeks;
- parent/guardian provides permission for minors to participate.
- Age 18 or above;
- parents/guardians of youth who meets inclusion criteria.
Who cannot join
- Not within the specified age range;
- presence of organic brain damage;
- inability to understand enrollment forms (e.g. Informed Assent/Consent Form)
- presence of organic brain damage.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Health Services
Los Angeles, California, 90032
About this study
This study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to assess the acceptability and feasibility of the integrated approach; and to pilot test the new program against standard care.
The investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.
- Conditions
- Substance Abuse, Traumatic Stress
- Being tested
- Trauma-focused Substance Abuse Intervention
- Keywords
- Substance Abuse, Traumatic Stress
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused Substance Abuse InterventionBehavioural
An integrated treatment approach to reduce substance use and PTSD symptoms. The intervention program includes: 1) 1-2 individual sessions during which youth talk about the trauma, during the course of the intervention program; 2) 16 group sessions for youth; 3) 2 conjoint sessions with parents to improve communication and problem-solving skills; and 4) 2 parent-education group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | The Standard of Care condition includes: 1) an individual session with the counselor, once per week; 2) a treatment group with the counselor, twice per week; and 3) parents of youth are invited to attend parent-only educational sessions weekly. |
| Trauma-focused Substance Abuse Intervention | Experimental | See Intervention Arm description. Receives: Behavioral: Trauma-focused Substance Abuse Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-back (TFLB) Assessment of Substance Use
The TLFB uses a blank calendar form and a series of questions to cue recall of alcohol and drug (AOD) use. The investigators will use the TLFB interview technique to assess AOD use weekly.
Measured: Participants will be followed for an expected average of 12 weeks.
Urine Toxicology Screen (UTS)
Urine samples will be collected twice per week at the treatment site to ensure validity of self-reports.
Measured: Participants will be followed for an expected average of 12 weeks.
Child PTSD Symptom Scale (CPSS)
The CPSS will assess for severity of traumatic stress symptoms.
Measured: Change from Baseline in Child PTSD Symptom Scale at 8 weeks and change from Baseline in Child PTSD Symptom Scale at 12 weeks.
Secondary outcomes (2)
Child Post-Trauma Attitudes Scale (C-PTAS)
The C-PTAS will be used to assess trauma-related attitudes and beliefs.
Measured: Baseline & 8 weeks & 3 months
Strengths & Difficulties Questionnaire (SDQ)
The SDQ will be used to assess parent-report of behavioral problems.
Measured: Baseline & 8 weeks & 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy S Wu, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825694
- Sponsor's protocol ID
- 1R34DA031301
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2012
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
- ClinicalTrials.gov ID
- NCT01825694
- Acronym / sponsor ID
- 1R34DA031301
- Conditions
- Substance Abuse, Traumatic Stress
- Keywords
- Substance Abuse, Traumatic Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Apr 2013 (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.
This study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to assess the acceptability and feasibility of the integrated approach; and to pilot test the new program against standard care.
The investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –The Standard of Care condition includes: 1) an individual session with the counselor, once per week; 2) a treatment group with the counselor, twice per week; and 3) parents of youth are invited to attend parent-only educational sessions weekly. |
| Trauma-focused Substance Abuse Intervention | Experimental | Behavioral: Trauma-focused Substance Abuse InterventionSee Intervention Arm description. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Between ages of 13 \& 19;
- meeting DSM IV criteria for substance abuse/dependence and PTSD;
- previously enrolled at recruitment site for at least 2 weeks;
- parent/guardian provides permission for minors to participate.
- Age 18 or above;
Key exclusion criteria (4 listed)
- Not within the specified age range;
- presence of organic brain damage;
- inability to understand enrollment forms (e.g. Informed Assent/Consent Form)
- presence of organic brain damage.
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 |
|---|---|---|
| Trauma-focused Substance Abuse InterventionAn integrated treatment approach to reduce substance use and PTSD symptoms. The intervention program includes: 1) 1-2 individual sessions during which youth talk about the trauma, during the course of the intervention program; 2) 16 group sessions for youth; 3) 2 conjoint sessions with parents to improve communication and problem-solving skills; and 4) 2 parent-education group sessions. | Behavioural | Trauma-focused Substance Abuse Intervention |
Primary outcome
Timeline Follow-back (TFLB) Assessment of Substance Use
Time frame: Participants will be followed for an expected average of 12 weeks.
The TLFB uses a blank calendar form and a series of questions to cue recall of alcohol and drug (AOD) use. The investigators will use the TLFB interview technique to assess AOD use weekly.
Urine Toxicology Screen (UTS)
Time frame: Participants will be followed for an expected average of 12 weeks.
Urine samples will be collected twice per week at the treatment site to ensure validity of self-reports.
Child PTSD Symptom Scale (CPSS)
Time frame: Change from Baseline in Child PTSD Symptom Scale at 8 weeks and change from Baseline in Child PTSD Symptom Scale at 12 weeks.
The CPSS will assess for severity of traumatic stress symptoms.
2 secondary outcomes
Child Post-Trauma Attitudes Scale (C-PTAS)
Time frame: Baseline & 8 weeks & 3 months
Strengths & Difficulties Questionnaire (SDQ)
Time frame: Baseline & 8 weeks & 3 months
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 29 Sep 2023.
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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.
Nancy S Wu, MD 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 Trauma-focused Substance Abuse Intervention in people with Substance Abuse and Traumatic Stress, 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 6 inclusion and 4 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 29 Sep 2023. 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?
Timeline Follow-back (TFLB) Assessment of Substance Use (time frame: Participants will be followed for an expected average of 12 weeks.). The study lists 3 primary outcomes in all. 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 29 Sep 2023.