Parent-Child RelationsNCT03916172
Evaluation of Psychological Intervention for Parents of Adolescents
A study testing The Open Door Approach to Parenting Teenagers (APT) in people with Parent-Child Relations, run by Open Door Young People's Service at 1 site in United Kingdom.
Trial summary
Adolescence is a challenging period for young people and their parents. Changes during adolescence bring increases in social, psychological and behavioural problems (such as gang membership and drug abuse), and most long-lasting mental health problems start during this period. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- The Open Door Approach to Parenting Teenagers (APT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2018to Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a parent of an adolescent aged 11-18 years
- Adolescent currently lives with parent for a minimum of 2 days/week
- Parent demonstrates clinically significant levels of concern on primary measure (Stress Index for Parents of Adolescents)
- Parent must be proficient in English so they may fully understand the material presented to them during the research study
Who cannot join
- Parent currently receiving treatment for psychotic illness
- Parent previously received APT intervention
- Adolescent has severe developmental disorder (e.g. Autism Spectrum Disorder) or serious life threatening health impairment
- Adolescent currently receiving individual psychotherapeutic treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Open Door Young People's Consultation Service
London, N8 8PL
Alex Desiatnikov, 020 8348 5947, research@opendooronline.org
Lara Taylor, 02083485947, research@opendooronline.org
About this study
Official title: Randomised Evaluation of Brief Psychological Intervention for Parents of Adolescents: The Open Door Approach to Parenting Teenagers (APT), in London, England
Adolescence is a challenging period for young people and their parents. Changes during adolescence bring increases in social, psychological and behavioural problems (such as gang membership and drug abuse), and most long-lasting mental health problems start during this period. One of the strongest predictors of adolescent outcomes is the quality of parenting they receive at this stage. Parents often struggle with parenting adolescents, leading to feelings of stress and incompetence which, when reaching clinical levels, result in physical and mental health difficulties for parents and their children. This puts significant strain on community, social and mental health services. While the effectiveness of programmes to support parents of adolescents is certain, most are group-based and struggle to retain participants, especially amongst those who need help most: clinically stressed, and single parents. There are no standard care pathways for these parents, which leads to chronic problems and high long-term cost. The present study aims to measure the effectiveness of the Open Door's Approach to Parenting Teenagers (APT) - a manualised, six-session individual parenting intervention focusing on the relationship between parent and adolescent. This brief intervention, developed with awareness of the organisational realities and overarching aims of the National Health Service (NHS), has shown good results amongst clinically stressed parents in a pilot trial. The next phase in evaluating this approach is ruling out spontaneous recovery, by randomly assigning participants to APT or a waiting list control and comparing their results after the intervention, and again after 3 months. If successful, this study will have a major impact on communities around the United Kingdom (UK) - offering an evidence-based, non-proprietary intervention that can be easily disseminated.
Read the detailed description
This study is the next step in the evaluation trajectory of the Open Door Approach to Parenting Teenagers (APT), and is a randomised controlled trial investigating whether receiving APT is more effective than being on a Waiting List (WL) in a sample of 60 parents of adolescents. We hypothesise that in comparison to those on the WL, those receiving APT will show significant improvements in:
- parental stress;
- parent-adolescent relationship;
- adolescent and parent wellbeing and mental health outcomes;
Secondary aims of the study will include:
- Ascertaining treatment fidelity
- Disseminating outcomes to inform policymakers, commissioners and providers, to facilitate evidence-based decisions about community services.
Procedure This trial will be carried out at two clinical sites in North London over 12months.
Method:
Parents and adolescents in the APT condition will be measured 3 times: at baseline, end-of-treatment, and follow-ups at three after the end-of-treatment. Those in WL will be measured three times from pre-treatment to three months follow-up. Then they will be offered APT. Measures are grouped into four batteries: for the parent, the adolescent, the therapist and an observer, and they will measure changes in parental stress, perceptions of the parent about their adolescent's psychopathology and relational problems, aspects of parenting relevant to aetiology and treatment of adolescent issues. The batteries also include variables mediating recovery, therapeutic alliance, health services utilisation and therapists' adherence to the ATP model.
Analysis plan:
The primary outcome will be analysed using within- and between-groups mean differences to estimate treatment effects. Results will be disseminated through scientific papers, academic conferences, the Open Door (OD) website, and reports will be distributed among educational and health institutions in our local network. If results have merit, the intervention manual will be published, and training will be offered to professionals outside OD. If successful, we anticipate this study to have a major impact on communities around the UK. It is a non-proprietary intervention that can be easily disseminated.
- Conditions
- Parent-Child Relations
- Being tested
- The Open Door Approach to Parenting Teenagers (APT)
- Keywords
- Adolescence, Stress, Parent-adolescent relationship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Open Door Approach to Parenting Teenagers (APT)Behavioural
APT works on a one-to-one or couple basis. It offers 6 weekly 50-minute appointments with an optional 7th review session. The practitioners delivering the intervention have qualifications in psychology, or significant experience of working with adolescent populations, and have undertaken training and supervision in the model. Its aim is to help the parent manage the parenting of their teenager more effectively and establish a more balanced relationship by eliciting their views, feelings, and understanding of their teenager and their relationship, discussing their parental identity and role, carefully examining communication, responses, and information giving, and supporting appropriate boundary making. This is achieved through a collaborative development of strategies, psychoeducation and behavioural experiments.
| Study group | Role | What they receive |
|---|---|---|
| APT Treatment | Experimental | Participants in this arm will receive the Open Door Approach to Parenting Teenagers (APT). It offers 6 weekly 50-minute appointments with an optional 7th review session. Receives: Behavioral: The Open Door Approach to Parenting Teenagers (APT) |
| Waiting List | No intervention | Participants in this group will be placed on a waiting list and will receive APT treatment after no longer than 25 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Index for Parents of Adolescents (SIPA)
This is a 112-item, self report that is structured into three main domain scores: Adolescent Domain (AD), Parent Domain (PD), and Adolescent-Parent Relationship Domain (APRD). The AD has 4 subscale scores: Moodiness/Emotional Lability (MEL), Social Isolation/Withdrawal (ISO), Delinquency/Antisocial (DEL), and Failure to Achieve or Persevere (ACH). The PD also has 4 subscale: Life Restrictions (LFR), Relationship with Spouse/Partner (REL), Social Alienation (SOC) and Incompetence/Guilt (INC). The APRD has no subscales. The Index of Total Parenting Stress (TPS) is a composite score computed from all items. Scores are then classified into broad ranges: normal, borderline, clinically significant and clinically severe.
Measured: 5 months
Secondary outcomes (16)
Strengths And Difficulties Questionnaire Parent Version (SDQ-P)
Strengths and Difficulties Questionnaires (SDQ): a brief, parent-report, behavioural questionnaire. It comprises 25 items measuring emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour. The measure has excellent psychometric properties, and national norms have been extracted from a large national survey of child and adolescent mental health carried out by the Office for National Statistics. For all time-points except baseline, a follow-up version of the measure will be used, which adds questions regarding the intervention's impact.
Measured: 5 months
Strengths and Difficulties Questionnaire Young Person Version (SDQ-YP)
Strengths and Difficulties Questionnaires (SDQ): a brief, self-report, behavioural questionnaire. It comprises 25 items measuring emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour. The measure has excellent psychometric properties, and national norms have been extracted from a large national survey of child and adolescent mental health carried out by the Office for National Statistics. For all time-points except baseline, a follow-up version of the measure will be used, which adds questions regarding the intervention's impact.
Measured: 5 Months
Alabama Parenting Questionnaire - Short Form (APQ-SF)
A 12-item, self- report measure that focuses on parenting behaviours. The parent APQ measures five dimensions of parenting that are relevant to the aetiology and treatment of child and adolescent problems: positive involvement with children, supervision and monitoring, use of positive discipline techniques, consistency in the use of such discipline and use of corporal punishment. The APQ has good psychometric properties and has shown good discrimination between clinical and non-clinical groups.
Measured: 5 months
Patient Health Questionnaire Module 9 (PHQ-9)
A screen for depression, extensively used in the literature and clinical practice, with excellent psychometric properties.
Measured: 5 months
Generalised Anxiety Disorder Screener (GAD-7)
A 7-item screen with good sensitivity and specificity to capture and distinguish anxiety symptoms and disorders. Extensively used in clinical and research contexts.
Measured: 5 months
Alabama Parenting Questionnaire Young Person version (APQ-YP)
This measure is complementary to the parent version described above. It measures adolescents' perceptions about the parenting they receive.
Measured: 5 months
EQ-5D-5L
This is a standardised instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. It consists of a descriptive system and the EQ Visual Analogue Scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
Measured: 5 months
Reflective Function Questionnaire (RFQ)
A brief, easy-to-administer screening measure of reflective functioning. It comprises 8 items yielding two sub-scales assessing certainty and uncertainty of mental states.
Measured: 5 months
Conflict Behaviour Questionnaire (CBQ)
A 20-item questionnaire that assesses perceived communication and conflict in the parent-adolescent relationship. The CBQ has good psychometric properties and has been found to successfully discriminate between distressed and non-distressed families. Both parent-report and self-report for adolescent versions will be used.
Measured: 5 months
Parenting Scale (PS)
This is a 30-item questionnaires that measures two dysfunctional discipline styles in parents: Laxness and Over-reactivity, and also measures verbosity. This scale has good psychometric properties and has been found to discriminate between parents of clinic and non-clinic children.
Measured: 5 months
Goal Based Measure
Developed by the Child Outcomes Research Consortium. Part of Open Door's regular practice. It is a simple form that lists the patient's goals for the treatment, and every session the patient rates their accomplishment from zero to ten.
Measured: 5 months
Working Alliance Inventory-Short Form-Client (WAI-SF-C)
This measure will only be included in the end- of-treatment battery. This is a 12 item questionnaire , which assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. This brief measure has excellent psychometric properties.
Measured: 5 months
Working Alliance Inventory-Short Form-Therapist (WAI-SF-T)
The therapist counterpart for the measure listed above. It will be completed by therapists at the end of treatment and is a 12-item scale that measures the alliance elements described above.
Measured: 5 months
Working Alliance Inventory-Observer (WAI-O)
The observer counterpart of the measure described above. It is a 32-item scale that measures the alliance elements described above.
Measured: 5 months
Experience of Services Questionnaire
This measure will only be included in the end-of-treatment battery. This is part of Open Door's regular practice. The questionnaire addresses the quality of service provided: how well the intervention met the participants' needs, increased their skills, decreased the adolescent's problem behaviours, and whether the participants would recommend the program to others.
Measured: 5 months
Adherence to the APT Model
The APT manualised model includes checklists to be filled out by observers for each of the six sessions. Only 1 session per participant will be scored and scoring will be performed by supervisors on a randomly selected intervention session's video. These checklists contain both concrete actions the therapist must carry out during the selected session and elements regarding both the therapeutic stance, such as level of activity/passivity of the therapist.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start12 Dec 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Open Door Young People's Service
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Desiatnikov, Open Door Young People's Service
- Investigators
- Alex Desiatnikov, Principal investigator, Open Door Young People's Consultation Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916172
- Sponsor's protocol ID
- 254697
- Status last verified
- Apr 2019
- First submitted
- 12 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Desatnik A, Jones C, Fonagy P, Britton J, Hayward V, Glover R, Taylor L, Lorenzini N. Study protocol for a randomised evaluation of a brief psychological intervention for clinically stressed parents of adolescents: Approach for Parenting Teenagers (APT). BMC Psychol. 2026 Mar 21;14(1):637. doi: 10.1186/s40359-026-04048-w.
PubMed 41865035
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Evaluation of Brief Psychological Intervention for Parents of Adolescents: The Open Door Approach to Parenting Teenagers (APT), in London, England
- ClinicalTrials.gov ID
- NCT03916172
- Acronym / sponsor ID
- 254697
- Conditions
- Parent-Child Relations
- Keywords
- Adolescence, Stress, Parent-adolescent relationship
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Open Door Young People's ServiceUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Apr 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.
Adolescence is a challenging period for young people and their parents. Changes during adolescence bring increases in social, psychological and behavioural problems (such as gang membership and drug abuse), and most long-lasting mental health problems start during this period. One of the strongest predictors of adolescent outcomes is the quality of parenting they receive at this stage. Parents often struggle with parenting adolescents, leading to feelings of stress and incompetence which, when reaching clinical levels, result in physical and mental health difficulties for parents and their children. This puts significant strain on community, social and mental health services. While the effectiveness of programmes to support parents of adolescents is certain, most are group-based and struggle to retain participants, especially amongst those who need help most: clinically stressed, and single parents. There are no standard care pathways for these parents, which leads to chronic problems and high long-term cost. The present study aims to measure the effectiveness of the Open Door's Approach to Parenting Teenagers (APT) - a manualised, six-session individual parenting intervention focusing on the relationship between parent and adolescent. This brief intervention, developed with awareness of the organisational realities and overarching aims of the National Health Service (NHS), has shown good results amongst clinically stressed parents in a pilot trial. The next phase in evaluating this approach is ruling out spontaneous recovery, by randomly assigning participants to APT or a waiting list control and comparing their results after the intervention, and again after 3 months. If successful, this study will have a major impact on communities around the United Kingdom (UK) - offering an evidence-based, non-proprietary intervention that can be easily disseminated.
Detailed description
This study is the next step in the evaluation trajectory of the Open Door Approach to Parenting Teenagers (APT), and is a randomised controlled trial investigating whether receiving APT is more effective than being on a Waiting List (WL) in a sample of 60 parents of adolescents. We hypothesise that in comparison to those on the WL, those receiving APT will show significant improvements in:
- parental stress;
- parent-adolescent relationship;
- adolescent and parent wellbeing and mental health outcomes;
Secondary aims of the study will include:
- Ascertaining treatment fidelity
- Disseminating outcomes to inform policymakers, commissioners and providers, to facilitate evidence-based decisions about community services.
Procedure This trial will be carried out at two clinical sites in North London over 12months.
Method:
Parents and adolescents in the APT condition will be measured 3 times: at baseline, end-of-treatment, and follow-ups at three after the end-of-treatment. Those in WL will be measured three times from pre-treatment to three months follow-up. Then they will be offered APT. Measures are grouped into four batteries: for the parent, the adolescent, the therapist and an observer, and they will measure changes in parental stress, perceptions of the parent about their adolescent's psychopathology and relational problems, aspects of parenting relevant to aetiology and treatment of adolescent issues. The batteries also include variables mediating recovery, therapeutic alliance, health services utilisation and therapists' adherence to the ATP model.
Analysis plan:
The primary outcome will be analysed using within- and between-groups mean differences to estimate treatment effects. Results will be disseminated through scientific papers, academic conferences, the Open Door (OD) website, and reports will be distributed among educational and health institutions in our local network. If results have merit, the intervention manual will be published, and training will be offered to professionals outside OD. If successful, we anticipate this study to have a major impact on communities around the UK. It is a non-proprietary intervention that can be easily disseminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APT Treatment | Experimental | Behavioral: The Open Door Approach to Parenting Teenagers (APT)Participants in this arm will receive the Open Door Approach to Parenting Teenagers (APT). It offers 6 weekly 50-minute appointments with an optional 7th review session. |
| Waiting List | No intervention | –Participants in this group will be placed on a waiting list and will receive APT treatment after no longer than 25 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being a parent of an adolescent aged 11-18 years
- Adolescent currently lives with parent for a minimum of 2 days/week
- Parent demonstrates clinically significant levels of concern on primary measure (Stress Index for Parents of Adolescents)
- Parent must be proficient in English so they may fully understand the material presented to them during the research study
Key exclusion criteria (4 listed)
- Parent currently receiving treatment for psychotic illness
- Parent previously received APT intervention
- Adolescent has severe developmental disorder (e.g. Autism Spectrum Disorder) or serious life threatening health impairment
- Adolescent currently receiving individual psychotherapeutic treatment
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 |
|---|---|---|
| The Open Door Approach to Parenting Teenagers (APT)APT works on a one-to-one or couple basis. It offers 6 weekly 50-minute appointments with an optional 7th review session. The practitioners delivering the intervention have qualifications in psychology, or significant experience of working with adolescent populations, and have undertaken training and supervision in the model. Its aim is to help the parent manage the parenting of their teenager more effectively and establish a more balanced relationship by eliciting their views, feelings, and understanding of their teenager and their relationship, discussing their parental identity and role, carefully examining communication, responses, and information giving, and supporting appropriate boundary making. This is achieved through a collaborative development of strategies, psychoeducation and behavioural experiments. | Behavioural | APT Treatment |
Primary outcome
Stress Index for Parents of Adolescents (SIPA)
Time frame: 5 months
This is a 112-item, self report that is structured into three main domain scores: Adolescent Domain (AD), Parent Domain (PD), and Adolescent-Parent Relationship Domain (APRD). The AD has 4 subscale scores: Moodiness/Emotional Lability (MEL), Social Isolation/Withdrawal (ISO), Delinquency/Antisocial (DEL), and Failure to Achieve or Persevere (ACH). The PD also has 4 subscale: Life Restrictions (LFR), Relationship with Spouse/Partner (REL), Social Alienation (SOC) and Incompetence/Guilt (INC). The APRD has no subscales. The Index of Total Parenting Stress (TPS) is a composite score computed from all items. Scores are then classified into broad ranges: normal, borderline, clinically significant and clinically severe.
16 secondary outcomes
Strengths And Difficulties Questionnaire Parent Version (SDQ-P)
Time frame: 5 months
Strengths and Difficulties Questionnaire Young Person Version (SDQ-YP)
Time frame: 5 Months
Alabama Parenting Questionnaire - Short Form (APQ-SF)
Time frame: 5 months
Patient Health Questionnaire Module 9 (PHQ-9)
Time frame: 5 months
Generalised Anxiety Disorder Screener (GAD-7)
Time frame: 5 months
Alabama Parenting Questionnaire Young Person version (APQ-YP)
Time frame: 5 months
EQ-5D-5L
Time frame: 5 months
Reflective Function Questionnaire (RFQ)
Time frame: 5 months
Conflict Behaviour Questionnaire (CBQ)
Time frame: 5 months
Parenting Scale (PS)
Time frame: 5 months
Goal Based Measure
Time frame: 5 months
Working Alliance Inventory-Short Form-Client (WAI-SF-C)
Time frame: 5 months
Working Alliance Inventory-Short Form-Therapist (WAI-SF-T)
Time frame: 5 months
Working Alliance Inventory-Observer (WAI-O)
Time frame: 5 months
Experience of Services Questionnaire
Time frame: 5 months
Adherence to the APT Model
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 41865035Desatnik A, Jones C, Fonagy P, Britton J, Hayward V, Glover R, Taylor L, Lorenzini N. Study protocol for a randomised evaluation of a brief psychological intervention for clinically stressed parents of adolescents: Approach for Parenting Teenagers (APT). BMC Psychol. 2026 Mar 21;14(1):637. doi: 10.1186/s40359-026-04048-w.
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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.
Alex Desiatnikov principal investigator
Open Door Young People's Consultation Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Open Door Approach to Parenting Teenagers (APT) in people with Parent-Child Relations, run by Open Door Young People's Service at 1 site in United Kingdom.
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 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Desiatnikov (02083485947, research@opendooronline.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Index for Parents of Adolescents (SIPA) (time frame: 5 months). 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 NCT03916172, 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 16 Apr 2019.