Substance AbusePhase 1ITSANNCT01188434
Integrating Interventions for Maternal Substance Abuse
A Phase 1 study testing ITSAN and Services as Usual in people with Substance Abuse and Child Neglect, run by Oregon Social Learning Center at 1 site in United States.
Trial summary
This Research Plan proposes Stage 1 Research integrating evidence based practices to address the needs of mothers referred to child welfare for substance abuse. Mothers with a history of methamphetamine abuse and child neglect will be recruited. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Substance Abuse, Child Neglect
- What is being tested?
- ITSAN and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2012
- Phase
- Phase 1
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Maternal Substance Abuse
- Child Welfare involvement
- Child Neglect
- English Speaking
- Child either remaining in the home or reunification plan in place
- Living in the county
Who cannot join
- Current involvement in other substance abuse treatment
- Current involvement in other parenting skills training
- parental rights terminated
- active psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Interventions for Maternal Substance Abuse and Child Neglect
This Research Plan proposes Stage 1 Research integrating evidence based practices to address the needs of mothers referred to child welfare for substance abuse. Mothers with a history of methamphetamine abuse and child neglect will be recruited. Using an intensive community based treatment, mothers will receive substance abuse treatment combined with parenting skills training and psychosocial support for basic needs (e.g., housing, employment). This project will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect compared to treatment as usual, with a population of substance abusing neglectful mothers referred through the Department of Child Welfare.
- Conditions
- Substance Abuse, Child Neglect
- Being tested
- ITSAN, Services as Usual
- Keywords
- Methamphetamine, Substance Abuse, Child Neglect, Child Welfare, Evidence Based Practice
- 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.
ITSANBehavioural
integrated behavioral intervention for substance abuse, parenting skills, and basic needs
Services as UsualBehavioural
Services as usual referred by child welfare
| Study group | Role | What they receive |
|---|---|---|
| Integrated Behavioral Treatment | Experimental | Combined substance abuse, parenting skills, and basic needs intervention Receives: Behavioral: ITSAN |
| casework treatment as usual | Active comparator | services as usual as referred by child welfare Receives: Behavioral: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Addiction Severity Index
self report of all substances used
Measured: Baseline, 6 months, 12 months
Service Utilization Survey
self report of social, medical, and mental health services received by parent and youth
Measured: monthly
Parenting Measures
Assessment battery of parenting beliefs, expectations, and behaviors
Measured: Baseline, 6 months, 12 months
Secondary outcomes (2)
Urinalysis
10 panel Urine Drug Screen Collection
Measured: monthly
Archival data from the Child Welfare system
System level data of new reports to the child welfare system
Measured: annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startSep 2007
- Primary completionJun 2012
- Study completionAug 2012
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Saldana, Oregon Social Learning Center
- Investigators
- Lisa Saldana, PhD, Principal investigator, OSLC Community Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188434
- Sponsor's protocol ID
- K23DA021603
- Acronym
- ITSAN
- Status last verified
- Apr 2015
- First submitted
- 23 Aug 2010
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Interventions for Maternal Substance Abuse and Child Neglect
- ClinicalTrials.gov ID
- NCT01188434
- Acronym / sponsor ID
- ITSAN / K23DA021603
- Conditions
- Substance Abuse, Child Neglect
- Keywords
- Methamphetamine, Substance Abuse, Child Neglect, Child Welfare, Evidence Based Practice
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Aug 2010 (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 Research Plan proposes Stage 1 Research integrating evidence based practices to address the needs of mothers referred to child welfare for substance abuse. Mothers with a history of methamphetamine abuse and child neglect will be recruited. Using an intensive community based treatment, mothers will receive substance abuse treatment combined with parenting skills training and psychosocial support for basic needs (e.g., housing, employment). This project will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect compared to treatment as usual, with a population of substance abusing neglectful mothers referred through the Department of Child Welfare.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Behavioral Treatment | Experimental | Behavioral: ITSANCombined substance abuse, parenting skills, and basic needs intervention |
| casework treatment as usual | Active comparator | Behavioral: Services as Usualservices as usual as referred by child welfare |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Maternal Substance Abuse
- Child Welfare involvement
- Child Neglect
- English Speaking
- Child either remaining in the home or reunification plan in place
Key exclusion criteria (4 listed)
- Current involvement in other substance abuse treatment
- Current involvement in other parenting skills training
- parental rights terminated
- active psychosis
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 |
|---|---|---|
| ITSANintegrated behavioral intervention for substance abuse, parenting skills, and basic needs | Behavioural | Integrated Behavioral Treatment |
| Services as UsualServices as usual referred by child welfare | Behavioural | casework treatment as usual |
Primary outcome
Addiction Severity Index
Time frame: Baseline, 6 months, 12 months
self report of all substances used
Service Utilization Survey
Time frame: monthly
self report of social, medical, and mental health services received by parent and youth
Parenting Measures
Time frame: Baseline, 6 months, 12 months
Assessment battery of parenting beliefs, expectations, and behaviors
2 secondary outcomes
Urinalysis
Time frame: monthly
Archival data from the Child Welfare system
Time frame: annually
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 Apr 2015.
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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.
Lisa Saldana, PhD principal investigator
OSLC Community Programs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITSAN and Services as Usual in people with Substance Abuse and Child Neglect, run by Oregon Social Learning Center 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 Apr 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Addiction Severity Index (time frame: Baseline, 6 months, 12 months). 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 Apr 2015.