Substance UseNCT02774525
Concurrent Treatment of Substance Abuse and Child Maltreatment
A study testing Reinforcement for drug & alcohol abstinence, Parenting intervention and Treatment as usual (TAU) in people with Substance Use and Child Maltreatment, run by University of South Carolina at 1 site in United States.
Trial summary
The co-occurrence of child maltreatment and parental substance-use problems is a major public health problem with serious consequences for children, parents, families, and the community at large. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use, Child Maltreatment
- What is being tested?
- Reinforcement for drug & alcohol abstinence, Parenting intervention and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 31 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- open child protective services case for child maltreatment
- beginning intensive outpatient treatment for drug or alcohol use problem
- at least one child 2-8 years of age
Who cannot join
- not primary custodial parent for child 2-8 years of age
- serious mental illness
- residing outside the two participating counties
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Parenting & Family Res Center
Columbia, South Carolina, 29208
About this study
The co-occurrence of child maltreatment and parental substance-use problems is a major public health problem with serious consequences for children, parents, families, and the community at large. The need for effective dual treatment of caregiver substance abuse and child maltreatment is unquestionable, but there is a dearth of controlled treatment outcome studies with substance-using parents who have engaged in child maltreatment. This project examines two evidence-based treatments-Contingency Management for substance-use problems and Pathways Triple P parenting intervention to improve parenting for prevention of child-maltreatment recurrence. These two systematic interventions are being tested in the context of traditional outpatient treatment for substance-use problems.
- Conditions
- Substance Use, Child Maltreatment
- Being tested
- Reinforcement for drug & alcohol abstinence, Parenting intervention, Treatment as usual (TAU)
- Keywords
- child welfare system, parental substance use problem, child maltreatment, parenting
- 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.
Reinforcement for drug & alcohol abstinenceBehavioural
Also called Contingency management for negative drug & alcohol samples
Parenting interventionBehavioural
Also called Pathways Triple P
Treatment as usual (TAU)Behavioural
Outpatient substance-abuse therapy plus drug \& alcohol screening plus support for personal goal setting
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Outpatient substance-abuse treatment plus drug and alcohol screening plus brief support for personal goal setting Receives: Behavioral: Treatment as usual (TAU) |
| Contingency Management | Experimental | Contingency management for drug and alcohol abstinence plus TAU Receives: Behavioral: Reinforcement for drug & alcohol abstinence; Behavioral: Treatment as usual (TAU) |
| Parenting Intervention | Experimental | Parenting intervention plus TAU Receives: Behavioral: Parenting intervention; Behavioral: Treatment as usual (TAU) |
| Parenting Intervention + Contingency Management | Experimental | Parenting intervention plus contingency management for drug and alcohol abstinence plus TAU Receives: Behavioral: Reinforcement for drug & alcohol abstinence; Behavioral: Parenting intervention; Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
longest duration of negative urine and breath samples
Measured: 13 weeks
recurrence of child maltreatment--child protective services records
Measured: 18 months after baseline
Secondary outcomes (3)
self-reported substance use--Addiction Severity Index-Lite
Drug and Alcohol Composite (severity)
Measured: 4 months after baseline; 12 months after baseline; 18 months after baseline
parent report of child behavior problems--child behavior inventory
Intensity score for child behavior problems
Measured: 4 months after baseline; 12 months after baseline; 18 months after baseline
self-reported parenting--Parenting Scale; Parenting Practices Interview
Parenting Scale: Overreactivity; Laxness Parenting Practices Interview: Appropriate Discipline; Harsh and Inconsistent Discipline
Measured: 4 months after baseline; 12 months after baseline; 18 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startApr 2013
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Prinz, PhD, University of South Carolina
- Investigators
- Ron Prinz, Ph.D., Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774525
- Sponsor's protocol ID
- Pro00015175
- Status last verified
- May 2021
- First submitted
- 10 May 2016
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Treatment of Substance Abuse and Child Maltreatment
- ClinicalTrials.gov ID
- NCT02774525
- Acronym / sponsor ID
- Pro00015175
- Conditions
- Substance Use, Child Maltreatment
- Keywords
- child welfare system, parental substance use problem, child maltreatment, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 17 May 2016 (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 co-occurrence of child maltreatment and parental substance-use problems is a major public health problem with serious consequences for children, parents, families, and the community at large. The need for effective dual treatment of caregiver substance abuse and child maltreatment is unquestionable, but there is a dearth of controlled treatment outcome studies with substance-using parents who have engaged in child maltreatment. This project examines two evidence-based treatments-Contingency Management for substance-use problems and Pathways Triple P parenting intervention to improve parenting for prevention of child-maltreatment recurrence. These two systematic interventions are being tested in the context of traditional outpatient treatment for substance-use problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as usual (TAU)Outpatient substance-abuse treatment plus drug and alcohol screening plus brief support for personal goal setting |
| Contingency Management | Experimental | Behavioral: Reinforcement for drug & alcohol abstinence, Behavioral: Treatment as usual (TAU)Contingency management for drug and alcohol abstinence plus TAU |
| Parenting Intervention | Experimental | Behavioral: Parenting intervention, Behavioral: Treatment as usual (TAU)Parenting intervention plus TAU |
| Parenting Intervention + Contingency Management | Experimental | Behavioral: Reinforcement for drug & alcohol abstinence, Behavioral: Parenting intervention, Behavioral: Treatment as usual (TAU)Parenting intervention plus contingency management for drug and alcohol abstinence plus TAU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- open child protective services case for child maltreatment
- beginning intensive outpatient treatment for drug or alcohol use problem
- at least one child 2-8 years of age
Key exclusion criteria (3 listed)
- not primary custodial parent for child 2-8 years of age
- serious mental illness
- residing outside the two participating counties
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 |
|---|---|---|
| Reinforcement for drug & alcohol abstinenceAlso: Contingency management for negative drug & alcohol samples | Behavioural | Contingency Management, Parenting Intervention + Contingency Management |
| Parenting interventionAlso: Pathways Triple P | Behavioural | Parenting Intervention, Parenting Intervention + Contingency Management |
| Treatment as usual (TAU)Outpatient substance-abuse therapy plus drug \& alcohol screening plus support for personal goal setting | Behavioural | Contingency Management, Parenting Intervention, Parenting Intervention + Contingency Management, Treatment as Usual (TAU) |
Primary outcome
longest duration of negative urine and breath samples
Time frame: 13 weeks
recurrence of child maltreatment--child protective services records
Time frame: 18 months after baseline
3 secondary outcomes
self-reported substance use--Addiction Severity Index-Lite
Time frame: 4 months after baseline; 12 months after baseline; 18 months after baseline
parent report of child behavior problems--child behavior inventory
Time frame: 4 months after baseline; 12 months after baseline; 18 months after baseline
self-reported parenting--Parenting Scale; Parenting Practices Interview
Time frame: 4 months after baseline; 12 months after baseline; 18 months after baseline
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 12 May 2021.
- Individual participant dataSharing planned: No
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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.
Ron Prinz, Ph.D. principal investigator
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 Reinforcement for drug & alcohol abstinence, Parenting intervention and Treatment as usual (TAU) in people with Substance Use and Child Maltreatment, run by 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 3 inclusion and 3 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 12 May 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?
longest duration of negative urine and breath samples (time frame: 13 weeks). The study lists 2 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 12 May 2021.