Substance AbusePhase 1/2NCT01576393
Adolescent Involvement in Parental Substance Abuse Treatment
A Phase 1/2 study testing Home-based Family Therapy, office-based family therapy and WHE in people with Substance Abuse, run by Ohio State University at 1 site in United States.
Trial summary
Given the reciprocal nature of parent-child interaction, involvement of the adolescent in their mother's substance abuse treatment plan might be associated with reductions in adult relapse and improvements in child functioning. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Home-based Family Therapy, office-based family therapy and WHE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2015
- Phase
- Phase 1/2
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult mothers seeking outpatient treatment for alcohol or drug abuse or dependence as measured using the computerized diagnostic interview schedule (CDIS; Shaffer, 1992), and who report substance use within the past 90 days
- A child, between the ages of 8 to 16, lives with the mother at least 50% time over the prior 2 years or continuously for the 6 months prior to the assessment interview.
- If more than one 8-16 year old lives in the home, the one with the greater problem severity will be included in the study. Substance use will be probed ("Have you ever used alcohol or drugs?"). If one youth answers yes, and the other answers no, the one who answers yes will be included. If both child answer "yes", then the Form 90 substance use section [history and current pattern] will be administered to each. The child who reports the more severe pattern and history of use [age of onset, type of drug used, frequency of current use] will be included. If neither youth reports using alcohol or drugs, then the Youth Self-Report (Achenbach \& Edelbrock, 1982) will be administered and the youth with the greater total problem score will be included.
- Family lives within 60 miles of the treatment facility.
- Child and adult agree to participate in the assessment and treatment intervention.
Who cannot join
- 1. Evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by CDISC).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adolescent Involvement in Parental Substance Abuse Treatment: Evaluation of EBFT
Given the reciprocal nature of parent-child interaction, involvement of the adolescent in their mother's substance abuse treatment plan might be associated with reductions in adult relapse and improvements in child functioning. These findings would support the assertion that focus on family dynamics in substance abuse treatment programs is an effective use of resources and an important target of intervention efforts. One hundred eighty-three substance abusing mothers and their child (n=61 assigned to each condition) will receive treatment as usual (TAU) and be randomly assigned to 1) Ecologically-based family therapy (EBFT) conducted in the home or 2) Ecologically-based family therapy conducted at the treatment center, or 3) an attention control, Women's Health Education (WHE). In order to examine the endurance of treatment effects, this project will assess the parent and child at 3, 6, 12, and 18 months post-baseline.
Hypotheses
- It is expected that 1) mothers and children assigned to home and office based family therapy will show greater reductions in substance use and improvement in individual and family functioning at post-treatment compared to those in the attention control, and 2) those assigned to home-based family therapy will show greater reductions in substance use and improved individual and family functioning at post-treatment compared to those assigned to office-based family therapy.
- It is expected that 1) those assigned to home or office based family therapy will continue to maintain improvements in substance use, individual and family domains over time (time by treatment interaction) compared to those assigned to the attention control and 2) those assigned to home-based family therapy will continue to maintain improvements in substance use, individual and family domains over time (time by treatment interaction) compared to those assigned to office-based family therapy.
- It is hypothesized that improved family interaction skills will mediate substance use, individual and family outcomes.
- It is expected that EBFT in the home and EBFT in the office will be more cost effective than TAU, and that EBFT in the home will be more cost effective than EBFT in the office
Read the detailed description
Many researchers have studied the effects of parental alcohol and drug use on child outcomes. These studies conclude that parental substance use has the potential to negatively impact children's psychosocial development by depriving them of adequate care and supervision, impeding their socioemotional and cognitive development and/or influencing them to become substance users as well. Considering a bidirectional, systemic model for understanding the development, maintenance and recovery of substance use problems, it follows that the child impacts parents' behaviors as well. Family therapy has consistently shown that involvement of family members in the treatment of substance users is associated with higher levels of engagement and retention in treatment. Many studies report pre to post treatment reductions in substance use and related problems among those receiving couples and family therapy. While randomized clinical trials of family therapy have involved adult identified patients (IPs) in couples therapy and adolescent IPs in family therapy, this study will evaluate a family systems intervention involving an 8-16 year old child in the treatment plan of the adult treatment seeker. In the current study, alcohol and drug treatment seeking adult mothers of a child (8-16) living in the home will be engaged. All clients will be randomized to (1) ecologically-based family therapy (EBFT) in the home + treatment as usual (TAU), (2) EBFT at the office + TAU, or (3) TAU + attention control. The relative efficacy of this approach will be evaluated at 3, 6, 12, and 18 months post-baseline. Proposed change mechanisms (mediators) for family therapy will be evaluated. Differential treatment response as a function of gender, family history of alcohol or drug use, and primary alcohol v. drug abuse (moderators) will be investigated to better understand the intervention. The study will also examine how, if at all, treatment engagement and retention impact parent and adolescent response to treatment. Information gained through this project will help evaluate the utility of including adolescent family members in the treatment plan of their adult parents. Finally, the study will include an economic evaluation component to estimate the economic cost of each intervention and determine which condition is most cost effective. Intervention that includes a focus on parent-child interaction has the potential to enhance substance use reductions, reduce parent relapse, and improve family and emotional health among adults. Involvement of the child offers the opportunity to increase the potential protection of a positive parent-child relationship which is shown to be associated with positive developmental outcomes.
- Conditions
- Substance Abuse
- Being tested
- Home-based Family Therapy, office-based family therapy, WHE
- Keywords
- substance abuse, treatment, families
- 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.
Home-based Family TherapyBehavioural
Also called home-based Ecologically-based Family therapy
12 home-based family therapy sessions
office-based family therapyBehavioural
Also called Office-based Ecologically-based Family Therapy
12 office-based family therapy sessions
WHEBehavioural
Also called Women's Health Education Intervention
12 Women's Health Education Sessions
| Study group | Role | What they receive |
|---|---|---|
| Home-Based family therapy | Experimental | 12 home-based family therapy sessions Receives: Behavioral: Home-based Family Therapy |
| Office-based family therapy | Active comparator | 12 office-based family therapy sessions Receives: Behavioral: office-based family therapy |
| Women's Health Education | Placebo comparator | 12 womens's health education sessions Receives: Behavioral: WHE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Change in frequency of reported substance use
Measured: baseline, 3, 6, 12 and 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startAug 2009
- Primary completionMay 2014
- Study completionApr 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 Ohio State UniversityThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Natasha Slesnick, Ohio State University
- Investigators
- Natasha Slesnick, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576393
- Sponsor's protocol ID
- 2006B0269
- Other IDs
- R01DA023062
- Status last verified
- Sep 2015
- First submitted
- 9 Apr 2012
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Involvement in Parental Substance Abuse Treatment: Evaluation of EBFT
- ClinicalTrials.gov ID
- NCT01576393
- Acronym / sponsor ID
- 2006B0269
- Conditions
- Substance Abuse
- Keywords
- substance abuse, treatment, families
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2009
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Apr 2012 (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.
Given the reciprocal nature of parent-child interaction, involvement of the adolescent in their mother's substance abuse treatment plan might be associated with reductions in adult relapse and improvements in child functioning. These findings would support the assertion that focus on family dynamics in substance abuse treatment programs is an effective use of resources and an important target of intervention efforts. One hundred eighty-three substance abusing mothers and their child (n=61 assigned to each condition) will receive treatment as usual (TAU) and be randomly assigned to 1) Ecologically-based family therapy (EBFT) conducted in the home or 2) Ecologically-based family therapy conducted at the treatment center, or 3) an attention control, Women's Health Education (WHE). In order to examine the endurance of treatment effects, this project will assess the parent and child at 3, 6, 12, and 18 months post-baseline.
Hypotheses
- It is expected that 1) mothers and children assigned to home and office based family therapy will show greater reductions in substance use and improvement in individual and family functioning at post-treatment compared to those in the attention control, and 2) those assigned to home-based family therapy will show greater reductions in substance use and improved individual and family functioning at post-treatment compared to those assigned to office-based family therapy.
- It is expected that 1) those assigned to home or office based family therapy will continue to maintain improvements in substance use, individual and family domains over time (time by treatment interaction) compared to those assigned to the attention control and 2) those assigned to home-based family therapy will continue to maintain improvements in substance use, individual and family domains over time (time by treatment interaction) compared to those assigned to office-based family therapy.
- It is hypothesized that improved family interaction skills will mediate substance use, individual and family outcomes.
- It is expected that EBFT in the home and EBFT in the office will be more cost effective than TAU, and that EBFT in the home will be more cost effective than EBFT in the office
Detailed description
Many researchers have studied the effects of parental alcohol and drug use on child outcomes. These studies conclude that parental substance use has the potential to negatively impact children's psychosocial development by depriving them of adequate care and supervision, impeding their socioemotional and cognitive development and/or influencing them to become substance users as well. Considering a bidirectional, systemic model for understanding the development, maintenance and recovery of substance use problems, it follows that the child impacts parents' behaviors as well. Family therapy has consistently shown that involvement of family members in the treatment of substance users is associated with higher levels of engagement and retention in treatment. Many studies report pre to post treatment reductions in substance use and related problems among those receiving couples and family therapy. While randomized clinical trials of family therapy have involved adult identified patients (IPs) in couples therapy and adolescent IPs in family therapy, this study will evaluate a family systems intervention involving an 8-16 year old child in the treatment plan of the adult treatment seeker. In the current study, alcohol and drug treatment seeking adult mothers of a child (8-16) living in the home will be engaged. All clients will be randomized to (1) ecologically-based family therapy (EBFT) in the home + treatment as usual (TAU), (2) EBFT at the office + TAU, or (3) TAU + attention control. The relative efficacy of this approach will be evaluated at 3, 6, 12, and 18 months post-baseline. Proposed change mechanisms (mediators) for family therapy will be evaluated. Differential treatment response as a function of gender, family history of alcohol or drug use, and primary alcohol v. drug abuse (moderators) will be investigated to better understand the intervention. The study will also examine how, if at all, treatment engagement and retention impact parent and adolescent response to treatment. Information gained through this project will help evaluate the utility of including adolescent family members in the treatment plan of their adult parents. Finally, the study will include an economic evaluation component to estimate the economic cost of each intervention and determine which condition is most cost effective. Intervention that includes a focus on parent-child interaction has the potential to enhance substance use reductions, reduce parent relapse, and improve family and emotional health among adults. Involvement of the child offers the opportunity to increase the potential protection of a positive parent-child relationship which is shown to be associated with positive developmental outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home-Based family therapy | Experimental | Behavioral: Home-based Family Therapy12 home-based family therapy sessions |
| Office-based family therapy | Active comparator | Behavioral: office-based family therapy12 office-based family therapy sessions |
| Women's Health Education | Placebo comparator | Behavioral: WHE12 womens's health education sessions |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult mothers seeking outpatient treatment for alcohol or drug abuse or dependence as measured using the computerized diagnostic interview schedule (CDIS; Shaffer, 1992), and who report substance use within the past 90 days
- A child, between the ages of 8 to 16, lives with the mother at least 50% time over the prior 2 years or continuously for the 6 months prior to the assessment interview.
- If more than one 8-16 year old lives in the home, the one with the greater problem severity will be included in the study. Substance use will be probed ("Have you ever used alcohol or drugs?"). If one youth answers yes, and the other answers no, the one who answers yes will be included. If both child answer "yes", then the Form 90 substance use section [history and current pattern] will be administered to each. The child who reports the more severe pattern and history of use [age of onset, type of drug used, frequency of current use] will be included. If neither youth reports using alcohol or drugs, then the Youth Self-Report (Achenbach \& Edelbrock, 1982) will be administered and the youth with the greater total problem score will be included.
- Family lives within 60 miles of the treatment facility.
- Child and adult agree to participate in the assessment and treatment intervention.
Key exclusion criteria (1 listed)
- 1. Evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by CDISC).
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 |
|---|---|---|
| Home-based Family TherapyAlso: home-based Ecologically-based Family therapy12 home-based family therapy sessions | Behavioural | Home-Based family therapy |
| office-based family therapyAlso: Office-based Ecologically-based Family Therapy12 office-based family therapy sessions | Behavioural | Office-based family therapy |
| WHEAlso: Women's Health Education Intervention12 Women's Health Education Sessions | Behavioural | Women's Health Education |
Primary outcome
Substance use
Time frame: baseline, 3, 6, 12 and 18-months
Change in frequency of reported substance use
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 22 Sep 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.
Natasha Slesnick, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Home-based Family Therapy, office-based family therapy and WHE in people with Substance Abuse, run by Ohio State University 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 5 inclusion and 1 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 22 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Substance use (time frame: baseline, 3, 6, 12 and 18-months). 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 Sep 2015.