Child AbuseNCT04382677
Families Together: Intervention for Reunified Families
A study testing Promoting First Relationships ® and Resource & Referral in people with Child Abuse and Child Neglect, run by University of Washington at 1 site in United States.
Trial summary
Birth parents of young children who have been placed into foster care are a highly vulnerable population of caregivers. Little is known about the ability of existing prevention programs to intervene with birth parents who have recently been reunified with their children under the age of six. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Abuse, Child Neglect
- What is being tested?
- Promoting First Relationships ® and Resource & Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Birth parents reunited with their child (age 1-5 years) after a foster or kin care placement in trial return home status
- Parenting the child at study enrollment
- Child Welfare case served by the following Washington State offices: all of Region 2 South, Lynnwood, Tacoma, Everett, Smokey Point, and Lakewood
- Birth parents must be age 18 or older, mothers and fathers are eligible (one parent per study child enrolled)
- Conversant in English
- Access to a telephone
- Housing situation allows for home visits
Who cannot join
- Experiencing an acute crisis (e.g., hospitalization, incarceration)
- Previously received the Promoting First Relationships ® intervention or Child Parent Psychotherapy (CPP)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Child, Family, and Population Health Nursing
Seattle, Washington, 98105
About this study
Official title: Intervention to Improve Outcomes for Foster Children Reunited With Their Birth Families
Birth parents of young children who have been placed into foster care are a highly vulnerable population of caregivers. Little is known about the ability of existing prevention programs to intervene with birth parents who have recently been reunified with their children under the age of six. This project aims to evaluate a brief, home-visiting intervention model with a sample of reunified birth parents, examining its effectiveness to improve parenting and child wellbeing, and reduce reoccurrence of maltreatment and reunification failure.
Read the detailed description
There is no brief, home visiting, evidence-based intervention designed for and evaluated with Child Welfare System (CWS) birth parents and their children under six, once they are reunified. Why is this important? Because reunified birth parents represent one of the highest risk subpopulations of parents whose challenges contribute both to their child's exposure to stress and trauma and to the intergenerational transmission of impaired parenting, maltreatment, and foster care placement.
Reunified birth parents are more likely than other parents to have been foster children and survivors of childhood maltreatment. They have higher rates of co-morbid mental health disorders, substance abuse, poverty, low education, and homelessness. When their children are placed in out-of-home care as infants or toddlers, they are more likely to have longer stays in foster care than any other age group. Foster children are at risk for serious emotional, behavioral, neurological, and physiological health problems, and for continued relationship disruptions, maltreatment, and foster care placements throughout their life course. Birth parents need intervention services when they reunite with their child to support the already fragile parent-child relationship. Even when birth parents work hard to fulfill court requirements to regain custody of their child, they are often left without the skills necessary to establish a strong and lasting connection with their child. This failure of service, we believe, leads reunified families to experience a high rate of maltreatment reoccurrence and reentry into foster care.
In this application we will evaluate the effectiveness of a community based, home visiting intervention program with a population of birth parents recently reunified with their child under the age of six after a foster care placement. In order to do this, we first adapt the program by adding material relevant to reunified birth families and adapt the material for older children. We will evaluate the effectiveness of Promoting First Relationships ® (PFR; Kelly et al., 2008) to meet the parenting needs of this vulnerable population. Promoting First Relationships was originally designed for children birth to three, and we will expand the curriculum to meet the needs of children through age six. Through a strong, established community partnership between the state, a community mental health agency, and the University of Washington, we will 1) adapt Promoting First Relationships ® (PFR) for reunified birth families and older children; 2) test the effectiveness of PFR to improve parental quality and parent-child interaction as compared to a Resource and Referral service; 3) test the effectiveness of PFR on reducing social, emotional, and behavioral problems in a population of children at risk for elevated emotional and behavioral disorders; 4) test the effectiveness of PFR in reducing referrals to Child Protective Services (CPS) and re-entry into foster care.
Participants complete baseline assessments during an observation-only period. The parent-child dyad is randomized following the baseline assessment. They then receive the study intervention for 7-43 weeks, after which no further intervention is delivered. Outcome assessments are conducted during the post-intervention follow-up period immediately after completion of the intervention and again 6 months later. Outcome assessments are obtained (if possible) even when the intervention is not completed, for intent-to-treat analyses.
- Conditions
- Child Abuse, Child Neglect
- Being tested
- Promoting First Relationships ®, Resource & Referral
- Keywords
- Child Welfare, Child Protective Services, Parenting, Child maltreatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting First Relationships ®Behavioural
Also called PFR
Promoting First Relationships ® is based on attachment theory and is strengths-based. The 12 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to their concerns, and establishing a positive, supportive relationship. The provider videotapes playtime between parent and child, and alternates weeks watching the video with the parent, reflecting about the needs of both parent and child (reflective observation). PFR consultation strategies include Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts. These core strategies enhance parents' sense of security and competency. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify their own feelings and needs around parenting.
Resource & ReferralOther
Also called R&R
This condition consists of 1) Resource \& Referral assistance provided over the phone, and 2) Local Services Resource Packet. Throughout the intervention period, the provider makes monthly phone calls to offer further support to families, answer questions, and provide additional resources. The provider has at least four interactions with each family served. In addition, families in this condition have the Resource and Referral Specialist's phone number and they can call if an additional need arises. The resource packet includes local information organized by type of need or resource. These packets are updated regularly as services change over time.
| Study group | Role | What they receive |
|---|---|---|
| Promoting First Relationships | Experimental | The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers. Receives: Behavioral: Promoting First Relationships ® |
| Resource & Referral | Other | The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls. Receives: Other: Resource & Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Welfare Services Removal From Birth Parent Home
Official child welfare administrative records indicating whether the child in they dyad was removed from the birth parent home. 18 months post enrollment is approximately 1 year post intervention for those who completed interventions on schedule
Measured: 18 months post enrollment in the study
Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)
Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.
Measured: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)
Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.
Measured: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Change in Parenting Knowledge of Child Development
14-item Likert-scale questionnaire developed by the study, "Raising a Child," is a measure of caregivers' knowledge of children's social-emotional needs and developmentally appropriate expectations. Items are scored on a scale ranging from 1 to 4 points. The Raising a Child scale score is the sum of the 14 items; the range is 14 to 56 with higher scores indicating greater parenting knowledge (better outcome).
Measured: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Parenting Knowledge of Child Development
14-item Likert-scale questionnaire developed by the study, "Raising a Child," is a measure of caregivers' knowledge of children's social-emotional needs and developmentally appropriate expectations. Items are scored on a scale ranging from 1 to 4 points. The Raising a Child scale score is the sum of the 14 items; the range is 14 to 56 with higher scores indicating greater parenting knowledge (better outcome).
Measured: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Secondary outcomes (4)
Change in Child Externalizing Problem Behavior
Child externalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach \& Rescorla, 2000). The externalizing scale has 24 items; raw scores can range from 0 to 48 with higher scores indicating more externalizing behaviors.
Measured: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Child Externalizing Problem Behavior
Child externalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach \& Rescorla, 2000). The externalizing scale has 24 items; raw scores can range from 0 to 48 with higher scores indicating more externalizing behaviors.
Measured: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Change in Child Internalizing Problem Behavior
Child internalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach \& Rescorla, 2000). The internalizing scale has 36 items; raw scores can range from 0 to 72 with higher scores indicating more internalizing behaviors.
Measured: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Child Internalizing Problem Behavior
Child internalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach \& Rescorla, 2000). The internalizing scale has 36 items; raw scores can range from 0 to 72 with higher scores indicating more internalizing behaviors.
Measured: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start20 Dec 2017
- Primary completion27 May 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Monica Oxford, University of Washington
- Investigators
- Monica L Oxford, MSW, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382677
- Sponsor's protocol ID
- D-110816-S
- Other IDs
- R01HD090176
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2020
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oxford ML, Hash JB, Lohr MJ, Fleming CNB, Nelson DC, Spieker SJ. A Randomized Controlled Trial of Promoting First Relationships(R) Program With Parent-Child Dyads Reunified After Child Welfare System Separation. Child Maltreat. 2026 Oct 1:10775595261488410. doi: 10.1177/10775595261488410. Online ahead of print.
PubMed 42820846
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve Outcomes for Foster Children Reunited With Their Birth Families
- ClinicalTrials.gov ID
- NCT04382677
- Acronym / sponsor ID
- D-110816-S
- Conditions
- Child Abuse, Child Neglect
- Keywords
- Child Welfare, Child Protective Services, Parenting, Child maltreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Posted 14 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Birth parents of young children who have been placed into foster care are a highly vulnerable population of caregivers. Little is known about the ability of existing prevention programs to intervene with birth parents who have recently been reunified with their children under the age of six. This project aims to evaluate a brief, home-visiting intervention model with a sample of reunified birth parents, examining its effectiveness to improve parenting and child wellbeing, and reduce reoccurrence of maltreatment and reunification failure.
Detailed description
There is no brief, home visiting, evidence-based intervention designed for and evaluated with Child Welfare System (CWS) birth parents and their children under six, once they are reunified. Why is this important? Because reunified birth parents represent one of the highest risk subpopulations of parents whose challenges contribute both to their child's exposure to stress and trauma and to the intergenerational transmission of impaired parenting, maltreatment, and foster care placement.
Reunified birth parents are more likely than other parents to have been foster children and survivors of childhood maltreatment. They have higher rates of co-morbid mental health disorders, substance abuse, poverty, low education, and homelessness. When their children are placed in out-of-home care as infants or toddlers, they are more likely to have longer stays in foster care than any other age group. Foster children are at risk for serious emotional, behavioral, neurological, and physiological health problems, and for continued relationship disruptions, maltreatment, and foster care placements throughout their life course. Birth parents need intervention services when they reunite with their child to support the already fragile parent-child relationship. Even when birth parents work hard to fulfill court requirements to regain custody of their child, they are often left without the skills necessary to establish a strong and lasting connection with their child. This failure of service, we believe, leads reunified families to experience a high rate of maltreatment reoccurrence and reentry into foster care.
In this application we will evaluate the effectiveness of a community based, home visiting intervention program with a population of birth parents recently reunified with their child under the age of six after a foster care placement. In order to do this, we first adapt the program by adding material relevant to reunified birth families and adapt the material for older children. We will evaluate the effectiveness of Promoting First Relationships ® (PFR; Kelly et al., 2008) to meet the parenting needs of this vulnerable population. Promoting First Relationships was originally designed for children birth to three, and we will expand the curriculum to meet the needs of children through age six. Through a strong, established community partnership between the state, a community mental health agency, and the University of Washington, we will 1) adapt Promoting First Relationships ® (PFR) for reunified birth families and older children; 2) test the effectiveness of PFR to improve parental quality and parent-child interaction as compared to a Resource and Referral service; 3) test the effectiveness of PFR on reducing social, emotional, and behavioral problems in a population of children at risk for elevated emotional and behavioral disorders; 4) test the effectiveness of PFR in reducing referrals to Child Protective Services (CPS) and re-entry into foster care.
Participants complete baseline assessments during an observation-only period. The parent-child dyad is randomized following the baseline assessment. They then receive the study intervention for 7-43 weeks, after which no further intervention is delivered. Outcome assessments are conducted during the post-intervention follow-up period immediately after completion of the intervention and again 6 months later. Outcome assessments are obtained (if possible) even when the intervention is not completed, for intent-to-treat analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promoting First Relationships | Experimental | Behavioral: Promoting First Relationships ®The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers. |
| Resource & Referral | Other | Other: Resource & ReferralThe service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Birth parents reunited with their child (age 1-5 years) after a foster or kin care placement in trial return home status
- Parenting the child at study enrollment
- Child Welfare case served by the following Washington State offices: all of Region 2 South, Lynnwood, Tacoma, Everett, Smokey Point, and Lakewood
- Birth parents must be age 18 or older, mothers and fathers are eligible (one parent per study child enrolled)
- Conversant in English
Key exclusion criteria (2 listed)
- Experiencing an acute crisis (e.g., hospitalization, incarceration)
- Previously received the Promoting First Relationships ® intervention or Child Parent Psychotherapy (CPP)
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 |
|---|---|---|
| Promoting First Relationships ®Also: PFRPromoting First Relationships ® is based on attachment theory and is strengths-based. The 12 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to their concerns, and establishing a positive, supportive relationship. The provider videotapes playtime between parent and child, and alternates weeks watching the video with the parent, reflecting about the needs of both parent and child (reflective observation). PFR consultation strategies include Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts. These core strategies enhance parents' sense of security and competency. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify their own feelings and needs around parenting. | Behavioural | Promoting First Relationships |
| Resource & ReferralAlso: R&RThis condition consists of 1) Resource \& Referral assistance provided over the phone, and 2) Local Services Resource Packet. Throughout the intervention period, the provider makes monthly phone calls to offer further support to families, answer questions, and provide additional resources. The provider has at least four interactions with each family served. In addition, families in this condition have the Resource and Referral Specialist's phone number and they can call if an additional need arises. The resource packet includes local information organized by type of need or resource. These packets are updated regularly as services change over time. | Other | Resource & Referral |
Primary outcome
Child Welfare Services Removal From Birth Parent Home
Time frame: 18 months post enrollment in the study
Official child welfare administrative records indicating whether the child in they dyad was removed from the birth parent home. 18 months post enrollment is approximately 1 year post intervention for those who completed interventions on schedule
Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)
Time frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.
Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)
Time frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.
Change in Parenting Knowledge of Child Development
Time frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
14-item Likert-scale questionnaire developed by the study, "Raising a Child," is a measure of caregivers' knowledge of children's social-emotional needs and developmentally appropriate expectations. Items are scored on a scale ranging from 1 to 4 points. The Raising a Child scale score is the sum of the 14 items; the range is 14 to 56 with higher scores indicating greater parenting knowledge (better outcome).
Change in Parenting Knowledge of Child Development
Time frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
14-item Likert-scale questionnaire developed by the study, "Raising a Child," is a measure of caregivers' knowledge of children's social-emotional needs and developmentally appropriate expectations. Items are scored on a scale ranging from 1 to 4 points. The Raising a Child scale score is the sum of the 14 items; the range is 14 to 56 with higher scores indicating greater parenting knowledge (better outcome).
4 secondary outcomes
Change in Child Externalizing Problem Behavior
Time frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Child Externalizing Problem Behavior
Time frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Change in Child Internalizing Problem Behavior
Time frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Child Internalizing Problem Behavior
Time frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42820846Oxford ML, Hash JB, Lohr MJ, Fleming CNB, Nelson DC, Spieker SJ. A Randomized Controlled Trial of Promoting First Relationships(R) Program With Parent-Child Dyads Reunified After Child Welfare System Separation. Child Maltreat. 2026 Oct 1:10775595261488410. doi: 10.1177/10775595261488410. Online ahead of print.
- 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.
Monica L Oxford, MSW, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting First Relationships ® and Resource & Referral in people with Child Abuse and Child Neglect, run by University of Washington 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 2 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 14 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?
Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Child Welfare Services Removal From Birth Parent Home (time frame: 18 months post enrollment in the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382677, which also lists 1 linked publication.
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 14 Apr 2026.