Substance Use DisordersNCT06489522
Parenting Intervention for Mothers With Substance Use Disorder
A study testing THRIVE in people with Substance Use Disorders and Children of Mothers With Substance Use Disorders, run by Boston Medical Center at 1 site in United States.
Trial summary
Children of mothers with substance use disorder (SUD) constitute a growing and highly vulnerable population. Evidence-based parenting interventions have the potential to both support parents' recovery and mental health by helping them cope with stress of parenthood and promote the optimal development of their children… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Substance Use Disorders, Children of Mothers With Substance Use Disorders
- What is being tested?
- THRIVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to 30 Oct 2025
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mothers:
- English speaking
- ≥ 18 years of age
- Mother to an index child between 3 years, 0 months to 6 years, 11 months of age who receives primary care at Boston Medical Center
- Primary caregiver to the index child,
- Engaged in formal SUD recovery supports (e.g., medication for opioid use disorder, support groups specific to people in recovery and falls into one of these two enrollment groups: A) "high-risk" substance use disorder defined >=1 episode of relapse within the past two years OR B) "low-risk" defined as zero episodes of relapse within the past two years.
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- Children:
- Between 3 years, 0 months to 6 years, 11 months of age,
- Enrolled mother is primary caregiver.
- THRIVE Therapist:
- Embedded social worker in the SOFAR program delivering the THRIVE intervention
- Clinical Stakeholders:
- Patient Navigators, program manager, pediatricians, peer recovery coaches involved in the care of mother-child dyads in the SOFAR Program.
Who cannot join
- Mothers:
- Has an index child who has complex medical problems (e.g., autism spectrum disorder) that significantly impact the child's ability to interact with the parent (determination by child's primary care pediatrician)
- Severe cognitive limitation or medical or psychiatric condition that limits their capacity to provide informed consent
- Concurrent participation in another parent training intervention
- Children:
- Has any complex medical problems (as assessed by their pediatrician) that significantly impact the child's ability to interact with the mother.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center, SOFAR Clinic
Boston, Massachusetts, 02118
About this study
Official title: Supporting the Implementation of a Parenting Intervention for Mothers With Substance Use Disorder in the Pediatric Medical Home
Children of mothers with substance use disorder (SUD) constitute a growing and highly vulnerable population. Evidence-based parenting interventions have the potential to both support parents' recovery and mental health by helping them cope with stress of parenthood and promote the optimal development of their children by supporting responsive parenting. The Supporting Our Families through Addiction and Recovery (SOFAR) pediatric medical home for families and children impacted by SUDs, with integrated behavioral health (IBH), provides an opportune setting for addressing the needs of mothers and children impacted by SUDs. While many families are thriving in the program, there is a strong unmet need for evidence-based parent-training interventions, particularly during the preschool period.
This study aims to evaluate the implementation of a brief, parent child interaction therapy (PCIT)-based intervention, entitled Threat, harm, risk, investigation, vulnerability and engagement (THRIVE), that will be offered in the SOFAR Clinic at Boston Medical Center. THRIVE is a safe, 6-session telehealth intervention that has been tested in pediatric and community-based settings. The evidence-based suggests that THRIVE is associated with significant improvements in child behaviors and parenting stress.
The investigators hypothesize that offering THRIVE through the SOFAR pediatric primary care program will be feasible and acceptable, improving access to and engagement in evidence-based parenting interventions among mothers with substance use disorder who receive parenting support through our integrated behavioral health model. In addition to studying the implementation of this evidence-based intervention, this study will allow the researchers to test data collection procedures (pre and post-interventions assessments) to inform a future clinical trial.
- Being tested
- THRIVE
- Keywords
- Parent Child Interaction Therapy (PCIT), Effective parenting skills, THRIVE, SOFAR clinic, Boston Medical Center
- 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.
THRIVEBehavioural
THRIVE is a brief, parent child interaction therapy (PCIT) based telehealth intervention delivered over 6-sessions that has been tested in pediatric and community-based settings.
| Study group | Role | What they receive |
|---|---|---|
| Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) intervention | Experimental | The THRIVE intervention will be offered by a trained therapist to participants (mother-child dyads) in the SOFAR Clinic. Receives: Behavioral: THRIVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the THRIVE intervention
The Therapy Attitude Inventory survey will be used to collect assess mother/birthing parent acceptability of the THRIVE intervention. It is a 16 item instrument with 5 potential response per Question. Scores can range from 16 to 80 and higher scores are associated with higher acceptability.
Measured: 12 months
Fidelity of the THRIVE intervention
The Treatment Integrity Checklist will be used to assess fidelity. It will be completed by research staff via review of video-recorded THRIVE sessions to monitor adherence to THRIVE core components.
Measured: 12 months
Feasibility of the THRIVE intervention based on enrollment
The number of families ineligible, approached, and enrolled will be documented from study records.
Measured: 12 months
Total number of THRIVE intervention sessions
The total number of sessions completed will be abstracted from the study records.
Measured: 12 months
Duration of THRIVE intervention sessions
The duration of the sessions will be documented in minutes.
Measured: 12 months
Percent of days homework completed
Percent of days homework completed will be obtained from study records
Measured: 12 months
Feasibility of the THRIVE intervention based on retention
Retention will be assessed by the time to loss of follow-up.
Measured: 12 months
Perceived reasons for discontinuation of THRIVE
The perceived reasons for discontinuation will be documented in the study records.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start17 Jan 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Approximately 10 high-risk mother-child dyads (defined as a mother having an episode of relapse in the past two years) and approximately 10 low-risk mother-child dyads (defined as mother not having any episodes of relapse in the past two-years) will be enrolled. There will be 1 therapist and 9 clinical stakeholders (Patient Navigators, program manager, pediatricians, peer recovery coaches involved in the care of mother-child dyads in the SOFAR Program).
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Mei Elansary, MD MPhil, Principal investigator, Boston Medical Center, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489522
- Sponsor's protocol ID
- H-44513
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting the Implementation of a Parenting Intervention for Mothers With Substance Use Disorder in the Pediatric Medical Home
- ClinicalTrials.gov ID
- NCT06489522
- Acronym / sponsor ID
- H-44513
- Keywords
- Parent Child Interaction Therapy (PCIT), Effective parenting skills, THRIVE, SOFAR clinic, Boston Medical Center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 8 Jul 2024 (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.
Children of mothers with substance use disorder (SUD) constitute a growing and highly vulnerable population. Evidence-based parenting interventions have the potential to both support parents' recovery and mental health by helping them cope with stress of parenthood and promote the optimal development of their children by supporting responsive parenting. The Supporting Our Families through Addiction and Recovery (SOFAR) pediatric medical home for families and children impacted by SUDs, with integrated behavioral health (IBH), provides an opportune setting for addressing the needs of mothers and children impacted by SUDs. While many families are thriving in the program, there is a strong unmet need for evidence-based parent-training interventions, particularly during the preschool period.
This study aims to evaluate the implementation of a brief, parent child interaction therapy (PCIT)-based intervention, entitled Threat, harm, risk, investigation, vulnerability and engagement (THRIVE), that will be offered in the SOFAR Clinic at Boston Medical Center. THRIVE is a safe, 6-session telehealth intervention that has been tested in pediatric and community-based settings. The evidence-based suggests that THRIVE is associated with significant improvements in child behaviors and parenting stress.
The investigators hypothesize that offering THRIVE through the SOFAR pediatric primary care program will be feasible and acceptable, improving access to and engagement in evidence-based parenting interventions among mothers with substance use disorder who receive parenting support through our integrated behavioral health model. In addition to studying the implementation of this evidence-based intervention, this study will allow the researchers to test data collection procedures (pre and post-interventions assessments) to inform a future clinical trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 10 high-risk mother-child dyads (defined as a mother having an episode of relapse in the past two years) and approximately 10 low-risk mother-child dyads (defined as mother not having any episodes of relapse in the past two-years) will be enrolled. There will be 1 therapist and 9 clinical stakeholders (Patient Navigators, program manager, pediatricians, peer recovery coaches involved in the care of mother-child dyads in the SOFAR Program).
| Arm | Type | Receives |
|---|---|---|
| Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) intervention | Experimental | Behavioral: THRIVEThe THRIVE intervention will be offered by a trained therapist to participants (mother-child dyads) in the SOFAR Clinic. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- English speaking
- ≥ 18 years of age
- Mother to an index child between 3 years, 0 months to 6 years, 11 months of age who receives primary care at Boston Medical Center
- Primary caregiver to the index child,
- Engaged in formal SUD recovery supports (e.g., medication for opioid use disorder, support groups specific to people in recovery and falls into one of these two enrollment groups: A) "high-risk" substance use disorder defined >=1 episode of relapse within the past two years OR B) "low-risk" defined as zero episodes of relapse within the past two years.
Key exclusion criteria (6 listed)
- Has an index child who has complex medical problems (e.g., autism spectrum disorder) that significantly impact the child's ability to interact with the parent (determination by child's primary care pediatrician)
- Severe cognitive limitation or medical or psychiatric condition that limits their capacity to provide informed consent
- Concurrent participation in another parent training intervention
- Has any complex medical problems (as assessed by their pediatrician) that significantly impact the child's ability to interact with the mother.
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 |
|---|---|---|
| THRIVETHRIVE is a brief, parent child interaction therapy (PCIT) based telehealth intervention delivered over 6-sessions that has been tested in pediatric and community-based settings. | Behavioural | Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) intervention |
Primary outcome
Acceptability of the THRIVE intervention
Time frame: 12 months
The Therapy Attitude Inventory survey will be used to collect assess mother/birthing parent acceptability of the THRIVE intervention. It is a 16 item instrument with 5 potential response per Question. Scores can range from 16 to 80 and higher scores are associated with higher acceptability.
Fidelity of the THRIVE intervention
Time frame: 12 months
The Treatment Integrity Checklist will be used to assess fidelity. It will be completed by research staff via review of video-recorded THRIVE sessions to monitor adherence to THRIVE core components.
Feasibility of the THRIVE intervention based on enrollment
Time frame: 12 months
The number of families ineligible, approached, and enrolled will be documented from study records.
Total number of THRIVE intervention sessions
Time frame: 12 months
The total number of sessions completed will be abstracted from the study records.
Duration of THRIVE intervention sessions
Time frame: 12 months
The duration of the sessions will be documented in minutes.
Percent of days homework completed
Time frame: 12 months
Percent of days homework completed will be obtained from study records
Feasibility of the THRIVE intervention based on retention
Time frame: 12 months
Retention will be assessed by the time to loss of follow-up.
Perceived reasons for discontinuation of THRIVE
Time frame: 12 months
The perceived reasons for discontinuation will be documented in the study records.
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 7 Apr 2026.
- 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.
Mei Elansary, MD MPhil principal investigator
Boston Medical Center, Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE in people with Substance Use Disorders and Children of Mothers With Substance Use Disorders, run by Boston Medical 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 13 inclusion and 6 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 7 Apr 2026. 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?
Acceptability of the THRIVE intervention (time frame: 12 months). The study lists 8 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 7 Apr 2026.