Substance-Related DisordersNCT03866694
Growing Together: Women in Opioid Treatment and Their Infants
A study testing BRIGHT and STAR/TAU+ in people with Substance-Related Disorders, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This study evaluates the effectiveness of the home-based therapeutic parenting intervention BRIGHT with pregnant women and postpartum mothers with opioid use disorders (OUDs) and their infants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- BRIGHT and STAR/TAU+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2018to 31 Mar 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient at BUMC RESPECT clinic with history of opioid use or history of polysubstance use
- 18 years or older
- Being treated with methadone, naltrexone, or suboxone
- In 3rd trimester of pregnancy
- Deemed by MDs able to give informed consent
- Planning to parent infant after birth
- Willing to participate in RCT
Who cannot join
- Planning to relinquish custody of neonate
- Residing, or expected to reside post-birth 20+ miles from Boston
- Deemed by MDs unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growing Together: A Pragmatic Clinical Trial of a Parenting Intervention for Women in Opioid Treatment and Their Infants
This study evaluates the effectiveness of the home-based therapeutic parenting intervention BRIGHT with pregnant women and postpartum mothers with opioid use disorders (OUDs) and their infants. It examines whether participation in the BRIGHT intervention improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, infant social-emotional development and decreases the likelihood of child maltreatment. Approximately half of the participants will receive the BRIGHT intervention, monthly handouts, and the standard of care at the maternal-fetal medical clinic and the other half will receive STAR, or Enhanced Treatment as Usual (TAU+), which includes monthly handouts and the standard of care from the medical clinic.
Read the detailed description
Growing Together is a two-armed pragmatic randomized controlled trial of a trauma and evidence-informed therapeutic parenting intervention, BRIGHT. This trial lasts approximately 9 months.
BRIGHT has been offered to young children ages birth through 6 years and their parents affected by substance use disorders (SUDs) to mitigate the effects of trauma, promote resilience, and enhance the quality of parent-child relationships and parenting skills. BRIGHT has been successfully piloted and evaluated within residential treatment and outpatient opioid treatment programs for pregnant women/mothers with SUDs and OUDs with young children .
For this study, BRIGHT has been adapted for home-based delivery for pregnant women receiving treatment for OUDs and is offered from the 3rd trimester of pregnancy until the infant is about 6 months old. Participants in both arms will be recruited from a high-risk maternal-fetal medicine clinic and followed for approximately 15 months. The two arms of the trial are 1) the BRIGHT (Building Resilience through Intervention, Growing Healthier Together) intervention, and 2) STAR. Both arms of the study will receive the typical standard of care of at a high-risk maternal-fetal medical clinic and 7 monthly psycho-educational handouts on child development specifically for mothers in recovery.
The investigators are testing the effectiveness of the adapted version of BRIGHT by utilizing measures to examine if participation in BRIGHT decreases the likelihood of child maltreatment, improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, and infant social-emotional development.
- Conditions
- Substance-Related Disorders
- Being tested
- BRIGHT, STAR/TAU+
- Keywords
- maternal opioid use, substance use, parent-child relationship, parenting, social and emotional development, mental health and well-being, perinatal, postpartum, health disparities
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIGHTBehavioural
Dyadic therapeutic parenting intervention (BRIGHT) beginning in third trimester of pregnancy through six months postpartum focusing on child-parent relationship, mental health, infant social-emotional development, and recovery. Monthly handouts for mothers in recovery with information about child development and recovery from substance misuse while parenting and the standard of care at participant's high risk maternal-fetal medical clinic.
STAR/TAU+Other
Monthly handouts for mothers in recovery with information about child development and recovery from substance misuse while parenting and the standard of care at participant's high risk maternal-fetal medical clinic
| Study group | Role | What they receive |
|---|---|---|
| BRIGHT | Experimental | Building Resilience through Intervention: Growing Healthier Together (BRIGHT) weekly home-based intervention from the third trimester of pregnancy through 6 months postpartum. A licensed clinician meets with mother and infant to promote attunement and optimal parent-child interactions. Additionally, the mother receives monthly handouts focused on information about child development and recovery from substance misuse while parenting, along with the standard of care at a high risk maternal-fetal medical clinic Receives: Behavioral: BRIGHT |
| STAR/TAU+ | Active comparator | The mother receives monthly handouts focused on information about child development and recovery from substance misuse while parenting, along with the standard of care at a high risk maternal-fetal medical clinic. Receives: Other: STAR/TAU+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coding Interactive Behavior (CIB) system (Observer-rated parent-infant video), measuring Maternal Sensitivity (representing the parent-child relationship)
CIB is a rating of mother-child interactions which has three 5-point Likert subscales: Maternal Sensitivity (MSense, primary outcome), Maternal intrusiveness (MIntrude), and Child involvement. (CInvolve). High scores on CIB scales indicate more evidence of the behavior/dimension. Moderate scores typically indicate presence of the behavior/dimension approximately 50% of the time. Low scores indicate that the behavior/dimension is never/infrequently observed. The CIB has been validated with healthy and at-risk populations. The study is assessing the change in CIB score between the time points.
Measured: t1 (6-8 Weeks postpartum), t2 (6-8 months postpartum)
The Adult- Adolescent Parenting Inventory-2 (AAPI), measuring the Risk of Child Maltreatment
Responses to the inventory provide an index of risk for practicing behaviors known to be attributable to child abuse and neglect. Answers are recorded on a scale from Strongly Agree to Strongly Disagree. Subscales include: Construct A - Inappropriate Expectations of Children, Construct B - Parental Lack of Empathy Towards Children's Needs, Construct C - Strong Parental Belief in the Use of Corporal Punishment, Construct D - Reversing Parent-Child Family Roles, Construct E - Oppressing Children's Power and Independence. 32-item inventory assessing parenting and child-rearing attitudes associated with risk for child maltreatment. Five parenting interaction constructs include, 1) inappropriate expectations for child, 2) empathic awareness of child's needs, 3) belief in corporal punishment, 4) role reversal and 5) oppressing children's power. Construct validity is well-established. Test-re-test reliability is .76. The study is assessing the change in AAPI score between the time points.
Measured: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
Secondary outcomes (10)
Karitane Parenting Confidence Scale (KPCS), measuring Parenting Capacity
15-item self-report measure of perceived parental self-efficacy, for parents of infants birth-12 months .82 The KPCS has good internal validity and test-re-test reliability is .88. Each item on the KPCS is scored 0, 1, 2, or 3, with scores summed to produce a total score. The general rule is that a high score indicates the parent is feeling confident on that item.
Measured: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
Parenting Stress Index/Short Form (PSI/SF), measuring Parenting Capacity
36-item self-report measure of parenting stress in 3 domains: parental distress, parent-child dysfunctional interaction, and parent's perceptions of child's difficulty. A high total stress score (above 90) indicates a greater level of parenting stress. The PSI/SF has excellent external validity, and test-re-test reliability is .76. Screening and triage measure for evaluating the parenting system and identifying issues that may lead to problems in the child's or parent's behavior. Focuses on three major domains of stress: child characteristics, parent characteristics and situational/demographic life stress. 1-5 Likert scale. 3 subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Child and Parent domains combine to form Total Stress Scale.
Measured: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
The Parental Reflective Functioning Questionnaire (PRFQ), measuring Parenting Capacity
Multidimensional assessment of parental reflective functioning in parents with children 0-5 years old. 1-7 Likert scale (1= Strongly Disagree, 7= Strongly Agree). 39-item measure of levels of reflective functioning - parent's ability to reflect upon and "see" their child's internal experiences, including wishes, fears, intentions, and emotions that drive children's behavior. Higher levels of reflective functioning indicate abilities to respond in a more empathetic and supportive manner. The PRFQ has good internal consistency and discriminant validity.
Measured: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
The Brief Symptom Inventory (BSI), measuring Maternal Mental Health (including continuation of OUD treatment)
Provides an overview of a patient's psychological symptoms and their intensity at a specific point in time. 0-4 Likert scale, lower scores are "better." 53-item self-report measure of mothers' psychological distress. Dimensions include depression, somatization, obsession-compulsion, anxiety, hostility, phobic anxiety, interpersonal sensitivity, paranoid ideation, and psychoticism. The BSI is known to have good reliability and validity.
Measured: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
The Life Stressor Checklist- Revised (LSC-R), measuring Maternal Mental Health (including continuation of OUD treatment)
22-item, self-report measure of traumatic or stressful life events. Stressful events are rated for occurrence (yes/no) and the age(s) of occurrence. The LSC-R maintains good criterion validity and test-retest reliability. A lower score is "better."
Measured: t0 (3rd trimester)
Connor-Davidson Resilience Scale-10 (CD-RISC 10), measuring Maternal Mental Health (including continuation of OUD treatment)
10-item assessment of resilience, specifically hardiness and persistence, has demonstrated strong psychometric properties. CDRS measures "bounce-back" and adaptability in relationship to stress. 0-4 Likert scale (0= Not true at all; 4= True nearly all the time). Higher scores are considered "better."
Measured: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
Post Traumatic Stress Disorder Checklist (PCL-5), measuring Maternal Mental Health (including continuation of OUD treatment)
20-item self-report questionnaire, corresponds to DSM-5 symptom criteria for PTSD. Rating scales span 0-4 for each symptom. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. Preliminary validation work suggests a cut point of 38. 0-4 Likert scale (0= Not at all; 4= Extremely) Lower scores are considered "better."
Measured: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
Addiction Severity Index (ASI), measuring Maternal Mental Health (including continuation of OUD treatment)
Semi-structured interview designed to address misuse of alcohol and drugs in the past 30 days and lifetime use in days and years. Lower numbers are considered "better."
Measured: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
Devereaux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), measuring Infant Social-Emotional Development
Standardized assessment of protective factors and screens for social/emotional risks and development in very young children, has demonstrated very good reliability and validity.89 Parents report perceptions of their child's qualities/abilities, yielding 2 scales: infant initiative and attachment, with an overall protective factors scale. It is recommended as a research tool to assess infants' and toddlers' social-emotional outcomes. 0-4 Likert scale (0= Never, 4= Very Frequently), higher values represent better outcomes
Measured: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
Parent Development Interview (PDI)- Short Form Revised 2016, measuring Parental Reflective Functioning
A semi-structured clinical interview that asks parents to describe the child, their internal experience of parenting, and their experience of the relationship with the child. The PI is coded by a trained and reliable PI coder using the Reflective Functioning Scale. -1 through 9 scale (-1: Negative; 9: Full or Exceptional). Higher scores indicate a high level of reflective functioning sophistication.
Measured: t0 (3rd trimester), t2 (6-8 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start13 Dec 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in this randomized controlled trial are assigned to one of two groups, BRIGHT or STAR. BRIGHT is a therapeutic parenting intervention that begins in the third trimester of pregnancy and continues through six months postpartum. BRIGHT and STAR receive the standard of care at a high risk maternal-fetal medical clinic and 7 psycho-educational handouts over the course of the study.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Institute for Health and Recovery (IHR), Boston University
- Responsible party
- Sponsor
- Investigators
- Ruth Paris, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866694
- Sponsor's protocol ID
- R40MC31764
- Status last verified
- Mar 2022
- First submitted
- 20 Nov 2018
- Last updated
- 20 Jul 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Together: A Pragmatic Clinical Trial of a Parenting Intervention for Women in Opioid Treatment and Their Infants
- ClinicalTrials.gov ID
- NCT03866694
- Acronym / sponsor ID
- R40MC31764
- Conditions
- Substance-Related Disorders
- Keywords
- maternal opioid use, substance use, parent-child relationship, parenting, social and emotional development, mental health and well-being, perinatal, postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Institute for Health and Recovery (IHR), Boston University
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 7 Mar 2019 (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.
This study evaluates the effectiveness of the home-based therapeutic parenting intervention BRIGHT with pregnant women and postpartum mothers with opioid use disorders (OUDs) and their infants. It examines whether participation in the BRIGHT intervention improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, infant social-emotional development and decreases the likelihood of child maltreatment. Approximately half of the participants will receive the BRIGHT intervention, monthly handouts, and the standard of care at the maternal-fetal medical clinic and the other half will receive STAR, or Enhanced Treatment as Usual (TAU+), which includes monthly handouts and the standard of care from the medical clinic.
Detailed description
Growing Together is a two-armed pragmatic randomized controlled trial of a trauma and evidence-informed therapeutic parenting intervention, BRIGHT. This trial lasts approximately 9 months.
BRIGHT has been offered to young children ages birth through 6 years and their parents affected by substance use disorders (SUDs) to mitigate the effects of trauma, promote resilience, and enhance the quality of parent-child relationships and parenting skills. BRIGHT has been successfully piloted and evaluated within residential treatment and outpatient opioid treatment programs for pregnant women/mothers with SUDs and OUDs with young children .
For this study, BRIGHT has been adapted for home-based delivery for pregnant women receiving treatment for OUDs and is offered from the 3rd trimester of pregnancy until the infant is about 6 months old. Participants in both arms will be recruited from a high-risk maternal-fetal medicine clinic and followed for approximately 15 months. The two arms of the trial are 1) the BRIGHT (Building Resilience through Intervention, Growing Healthier Together) intervention, and 2) STAR. Both arms of the study will receive the typical standard of care of at a high-risk maternal-fetal medical clinic and 7 monthly psycho-educational handouts on child development specifically for mothers in recovery.
The investigators are testing the effectiveness of the adapted version of BRIGHT by utilizing measures to examine if participation in BRIGHT decreases the likelihood of child maltreatment, improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, and infant social-emotional development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in this randomized controlled trial are assigned to one of two groups, BRIGHT or STAR. BRIGHT is a therapeutic parenting intervention that begins in the third trimester of pregnancy and continues through six months postpartum. BRIGHT and STAR receive the standard of care at a high risk maternal-fetal medical clinic and 7 psycho-educational handouts over the course of the study.
| Arm | Type | Receives |
|---|---|---|
| BRIGHT | Experimental | Behavioral: BRIGHTBuilding Resilience through Intervention: Growing Healthier Together (BRIGHT) weekly home-based intervention from the third trimester of pregnancy through 6 months postpartum. A licensed clinician meets with mother and infant to promote attunement and optimal parent-child interactions. Additionally, the mother receives monthly handouts focused on information about child development and recovery from substance misuse while parenting, along with the standard of care at a high risk maternal-fetal medical clinic |
| STAR/TAU+ | Active comparator | Other: STAR/TAU+The mother receives monthly handouts focused on information about child development and recovery from substance misuse while parenting, along with the standard of care at a high risk maternal-fetal medical clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A patient at BUMC RESPECT clinic with history of opioid use or history of polysubstance use
- 18 years or older
- Being treated with methadone, naltrexone, or suboxone
- In 3rd trimester of pregnancy
- Deemed by MDs able to give informed consent
Key exclusion criteria (3 listed)
- Planning to relinquish custody of neonate
- Residing, or expected to reside post-birth 20+ miles from Boston
- Deemed by MDs unable to give informed consent
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 |
|---|---|---|
| BRIGHTDyadic therapeutic parenting intervention (BRIGHT) beginning in third trimester of pregnancy through six months postpartum focusing on child-parent relationship, mental health, infant social-emotional development, and recovery. Monthly handouts for mothers in recovery with information about child development and recovery from substance misuse while parenting and the standard of care at participant's high risk maternal-fetal medical clinic. | Behavioural | BRIGHT |
| STAR/TAU+Monthly handouts for mothers in recovery with information about child development and recovery from substance misuse while parenting and the standard of care at participant's high risk maternal-fetal medical clinic | Other | STAR/TAU+ |
Primary outcome
Coding Interactive Behavior (CIB) system (Observer-rated parent-infant video), measuring Maternal Sensitivity (representing the parent-child relationship)
Time frame: t1 (6-8 Weeks postpartum), t2 (6-8 months postpartum)
CIB is a rating of mother-child interactions which has three 5-point Likert subscales: Maternal Sensitivity (MSense, primary outcome), Maternal intrusiveness (MIntrude), and Child involvement. (CInvolve). High scores on CIB scales indicate more evidence of the behavior/dimension. Moderate scores typically indicate presence of the behavior/dimension approximately 50% of the time. Low scores indicate that the behavior/dimension is never/infrequently observed. The CIB has been validated with healthy and at-risk populations. The study is assessing the change in CIB score between the time points.
The Adult- Adolescent Parenting Inventory-2 (AAPI), measuring the Risk of Child Maltreatment
Time frame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
Responses to the inventory provide an index of risk for practicing behaviors known to be attributable to child abuse and neglect. Answers are recorded on a scale from Strongly Agree to Strongly Disagree. Subscales include: Construct A - Inappropriate Expectations of Children, Construct B - Parental Lack of Empathy Towards Children's Needs, Construct C - Strong Parental Belief in the Use of Corporal Punishment, Construct D - Reversing Parent-Child Family Roles, Construct E - Oppressing Children's Power and Independence. 32-item inventory assessing parenting and child-rearing attitudes associated with risk for child maltreatment. Five parenting interaction constructs include, 1) inappropriate expectations for child, 2) empathic awareness of child's needs, 3) belief in corporal punishment, 4) role reversal and 5) oppressing children's power. Construct validity is well-established. Test-re-test reliability is .76. The study is assessing the change in AAPI score between the time points.
10 secondary outcomes
Karitane Parenting Confidence Scale (KPCS), measuring Parenting Capacity
Time frame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
Parenting Stress Index/Short Form (PSI/SF), measuring Parenting Capacity
Time frame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
The Parental Reflective Functioning Questionnaire (PRFQ), measuring Parenting Capacity
Time frame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
The Brief Symptom Inventory (BSI), measuring Maternal Mental Health (including continuation of OUD treatment)
Time frame: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
The Life Stressor Checklist- Revised (LSC-R), measuring Maternal Mental Health (including continuation of OUD treatment)
Time frame: t0 (3rd trimester)
Connor-Davidson Resilience Scale-10 (CD-RISC 10), measuring Maternal Mental Health (including continuation of OUD treatment)
Time frame: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
Post Traumatic Stress Disorder Checklist (PCL-5), measuring Maternal Mental Health (including continuation of OUD treatment)
Time frame: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
Addiction Severity Index (ASI), measuring Maternal Mental Health (including continuation of OUD treatment)
Time frame: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
Devereaux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), measuring Infant Social-Emotional Development
Time frame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
Parent Development Interview (PDI)- Short Form Revised 2016, measuring Parental Reflective Functioning
Time frame: t0 (3rd trimester), t2 (6-8 months postpartum)
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 20 Jul 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.
Ruth Paris, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIGHT and STAR/TAU+ in people with Substance-Related Disorders, run by Boston University Charles River Campus 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 7 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 20 Jul 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?
Coding Interactive Behavior (CIB) system (Observer-rated parent-infant video), measuring Maternal Sensitivity (representing the parent-child relationship) (time frame: t1 (6-8 Weeks postpartum), t2 (6-8 months postpartum)). 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 20 Jul 2026.