Challenging BehaviourNCT03086876
Evaluation of Parent Intervention for Challenging Behaviour in Children With Intellectual Disabilities (EPICC-ID)
A study testing Level 4 Stepping Stones Triple P (SSTP) in people with Challenging Behaviour, run by University College, London at 4 sites in United Kingdom.
Trial summary
Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. Read more about this study
- Who is it for?
- Ages 30 to 59 months
- Conditions the study is for
- Challenging Behaviour
- What is being tested?
- Level 4 Stepping Stones Triple P (SSTP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Jun 2017to 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 30 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: Parents 18 years or over; Child aged 30-59 months at identification;
- Child has moderate to severe intellectual disability (parent reported Adaptive Behaviour Assessment System (ABAS) General Adaptive Functioning 20-69);
- Written informed consent by parent/caregiver;
- Reports of challenging behaviour over a 6-month period but no less than 2 months.
Who cannot join
- Child has mild, profound or no LD on parent reported ABAS;
- Parent/carer has insufficient English language to complete study questionnaires;
- Another sibling is taking part in the study.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool
Central and North West London NHS Foundation Trust
London
Guy's and St Thomas NHS Foundation Trust
London
Northumberland, Tyne and Wear NHS Foundation Trust
Newcastle
About this study
Official title: Clinical and Cost Effectiveness of a Parent Mediated Intervention to Reduce Challenging Behaviour in Pre-schoolers With Moderate to Severe Learning Disability: a Randomised Controlled Trial
Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.The trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual (TAU) whilst the TAU group receive available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data is also being collected to carry out a cost effectiveness and utility evaluation. Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.
Read the detailed description
About 1-2% of the population have a Learning disability (LD). This is a lifelong condition characterised by an intelligence quotient (IQ) of less than 70, general developmental delay and limitations in day to day activities. Children and adults with LD are some of the most under-served groups in society, with well documented health disparities and at four times the risk of developing a mental disorder. Reports indicate that challenging behaviour, e.g. temper tantrums, aggression or self injury, occurs in as many as 40,000 young people under 18 years living in England. There is a significant evidence from research in the general population that parenting groups which support parents in developing skills to manage such behaviours in their child can be helpful. These programmes, if offered to parents early on, may reduce and even prevent serious emotional problems and possible criminality from developing in the child later in life. Cost benefits are associated with improved health and social outcomes in the young person.
The National Institute of Health and Care Excellence (NICE) guideline on behaviour that challenges reviewed all the available evidence and found very few thoroughly researched programmes specifically developed for children and young people with LD and challenging behaviour. NICE, therefore, recommended that further research should be undertaken to address the lack of evidence based interventions to reduce challenging behaviour in the population of young people with LD.
In this study, the investigators propose to evaluate a programme called level 4 Stepping Stones Triple P (SSTP) delivered by trained practitioners to groups of parents of young children aged 30-59 months with moderate to severe LD. The programme lasts for 9 weeks and has shown positive results in small trials outside the United Kingdom, indicating that it is a potentially helpful. However, it needs to be tested within the UK health system before recommendations can be made to roll it out. Level 4 SSTP helps parents understand and manage their child's behaviour and parents may benefit from peer support in a group setting. The investigators shall recruit 258 parents who will be allocated to one of two groups by chance: one will receive SSTP and treatment as usual and the other treatment as usual, a list of resources and the Contact a Family guide to challenging behaviour. Treatment as usual includes support and advice by General Practitioner's or child development teams. The investigators shall use parental reports and observations of child behaviour to examine whether SSTP reduces challenging behaviour at four (short term) and 12 (long term) months after randomisation. They will also ask other caregivers' about the child's behaviour, the child's and the parent's health related quality of life, difficulties with care, parent stress, service use and how the parent has found the intervention using both questionnaires and face to face interviews.The investigators shall interview the service managers and the therapists about their experience of hosting and delivering the intervention. Parents will also be recruited to the Parent Advisory Group to advise about various aspects of the study, e.g. materials, interview topic guides, dissemination. The researchers and clinicians have expertise in LD, child health and early intervention and have conducted several large trials with this population. The trial will last 48 months and will follow all statutory research governance requirements to ensure that it is high quality, safe and ethical.
- Conditions
- Challenging Behaviour
- Being tested
- Level 4 Stepping Stones Triple P (SSTP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level 4 Stepping Stones Triple P (SSTP)Behavioural
Stepping Stones Triple P is a system of psychoeducational and behavioural approaches to parenting a child with LD and challenging behaviour that aims to increase parental confidence and skills so that parents are able to manage the child's behavior effectively. SSTP comprises different levels based on increasing family complexity.
| Study group | Role | What they receive |
|---|---|---|
| Stepping Stones Triple P | Experimental | Trained practitioners will deliver Level 4 SSTP to parents in 6 weekly group sessions and will also provide 3 telephone of face to face contacts to each participant but they will not be involved in routine care for participants in either arm. Each therapist responsible for delivering SSTP will be trained in the Group Stepping Stones Training and Accreditation programme which includes three training days and a further half day accreditation workshop after 6 weeks. The group sessions not only educate but actively train the parents in skills and the individual consultations aim to facilitate independent problem solving. The learning objectives focus on maintaining behavioural change, using skills within a group learning environment, learning from peers in the group and sharing difficulties or achievements, providing support, considering if more intensive work is required, referring further if needed, talking about risk and protective factors operating within families. Receives: Behavioral: Level 4 Stepping Stones Triple P (SSTP) |
| Treatment as usual (TAU) | No intervention | TAU will be available to participants in both arms of the trial. It may include a range of services such as: 1. Health visitor services; 2. Primary care engagement and advice; 3. Potentially some version of early intervention maybe provided by either community paediatric services or Child and Adolescent Mental Health Services, although our understanding is that very little is available for children of this age. 4. Parenting advice and support sessions by carers groups or other third sector organisations. Parents allocated to TAU will receive a list of national and local resources and the Contact a Family guide to challenging behavior with tips and advice on social and health care supports. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behaviour Check List (CBCL)
Children's challenging behaviour will be measured at 12 months post randomisation using the parent completed preschool Child Behaviour Checklist (CBCL)
Measured: 12 months
Secondary outcomes (10)
Revised Family Observation Schedule (FOS-RIII)
Direct observations will be carried out by masked research assistants using the Revised Family Observation Schedule (FOS-RIII) as an objective measure of challenging behaviour
Measured: 12 months
Child Behaviour Checklist Caregiver-Teacher Report Forms (C-TRF)
Caregiver (not parent) reported child behaviour (Child Behaviour Checklist Caregiver-Teacher Report Forms; C-TRF). Most children in the sample age range will have additional care outside the parental home allowing us to have additional perspectives on the child's behaviour.
Measured: 12 months
General Health Questionnaire (GHQ)
We will measure parent psychiatric morbidity using the General Health Questionnaire. This well established instrument will provide additional information about common psychiatric morbidity in the parent.
Measured: 12 months
Questionnaire on Resources and Stress (QRS-F short form)
Parent stress will be measured using the Questionnaire on Resources and Stress QRS-F short form. This validated questionnaire measures stress in caregivers of chronically ill or children with LD.
Measured: 12 months
Caregiving Problem Checklist-Difficult Child Behaviour
Frequency of behaviour severity during care-giving tasks will be measured using the Caregiving Problem Checklist-Difficult Child Behaviour. This measure assesses the frequency of difficult child behaviour when the parent is completing care-giving tasks.
Measured: 12 months
Parenting Sense of Competence Scale (PSOC)
Satisfaction and efficacy as parent will be measured using the Parenting Sense of Competence Scale, PSOC. The Parenting Sense of Competence scale measures parent rated competence on the dimensions of Satisfaction and Efficacy as a parent.
Measured: 12 months
Child and Adolescent Service Use Schedule (CA-SUS)
Health and social care service use will be measured using the Child and Adolescent Service Use Schedule, CA-SUS. A modified version of the Child and Adolescent Service Use Schedule will be used in the trial.
Measured: 12 months
Pediatric Quality of Life (PedsQL)
Health related quality of life will be measured using the Pediatric Quality of Life, PedsQL. The measure covers Physical, Emotional, Social, School Functioning domains. It contains a parent proxy report for children aged 2 years and over. It will be used in the study to derive QALYS for the health economic evaluation.
Measured: 12 months
EuroQoL (EQ-5D)
Health related quality of life in the parent/other caregiver will be measured using the EQ-5D; 47. This self-completed questionnaire will capture parental and caregiver perspective on his/her health status which will be used in the economic evaluation.
Measured: 12 months
Client Satisfaction Questionnaire (CSQ)
Parent intervention acceptability will be measured using the Client Satisfaction Questionnaire. The questionnaire will allow parents to provide feedback about the intervention by commenting on their satisfaction with and experience of the intervention, including ease of use, format and helpfulness. It has been specifically developed for research in SSTP.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Jun 2017
- Primary completion17 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Challenging BehaviourStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Hassiotis, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086876
- Sponsor's protocol ID
- 15/162/02
- Status last verified
- Apr 2022
- First submitted
- 16 Mar 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ondruskova T, Oulton K, Royston R; EPICC-ID Research Group; Hassiotis A. Process evaluation of a parenting intervention for pre-schoolers with intellectual disabilities who display behaviours that challenge in the UK. J Appl Res Intellect Disabil. 2024 Sep;37(5):e13263. doi: 10.1111/jar.13263.
PubMed 39045819Ondruskova T, Royston R, Absoud M, Ambler G, Qu C, Barnes J, Hunter R, Panca M, Kyriakopoulos M, Oulton K, Paliokosta E, Sharma AN, Slonims V, Summerson U, Sutcliffe A, Thomas M, Dhandapani B, Leonard H, Hassiotis A. Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT. Health Technol Assess. 2024 Jan;28(6):1-94. doi: 10.3310/JKTY6144.
PubMed 38329108Farris O, Royston R, Absoud M, Ambler G, Barnes J, Hunter R, Kyriakopoulos M, Oulton K, Paliokosta E, Panca M, Paulauskaite L, Poppe M, Ricciardi F, Sharma A, Slonims V, Summerson U, Sutcliffe A, Thomas M, Hassiotis A. Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe intellectual disability (EPICC-ID) study protocol: a multi-centre, parallel-group randomised controlled trial. BMC Psychiatry. 2020 Jan 30;20(1):35. doi: 10.1186/s12888-020-2451-6.
PubMed 32000729
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost Effectiveness of a Parent Mediated Intervention to Reduce Challenging Behaviour in Pre-schoolers With Moderate to Severe Learning Disability: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03086876
- Acronym / sponsor ID
- 15/162/02
- Conditions
- Challenging Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 22 Mar 2017 (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 with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.The trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual (TAU) whilst the TAU group receive available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data is also being collected to carry out a cost effectiveness and utility evaluation. Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.
Detailed description
About 1-2% of the population have a Learning disability (LD). This is a lifelong condition characterised by an intelligence quotient (IQ) of less than 70, general developmental delay and limitations in day to day activities. Children and adults with LD are some of the most under-served groups in society, with well documented health disparities and at four times the risk of developing a mental disorder. Reports indicate that challenging behaviour, e.g. temper tantrums, aggression or self injury, occurs in as many as 40,000 young people under 18 years living in England. There is a significant evidence from research in the general population that parenting groups which support parents in developing skills to manage such behaviours in their child can be helpful. These programmes, if offered to parents early on, may reduce and even prevent serious emotional problems and possible criminality from developing in the child later in life. Cost benefits are associated with improved health and social outcomes in the young person.
The National Institute of Health and Care Excellence (NICE) guideline on behaviour that challenges reviewed all the available evidence and found very few thoroughly researched programmes specifically developed for children and young people with LD and challenging behaviour. NICE, therefore, recommended that further research should be undertaken to address the lack of evidence based interventions to reduce challenging behaviour in the population of young people with LD.
In this study, the investigators propose to evaluate a programme called level 4 Stepping Stones Triple P (SSTP) delivered by trained practitioners to groups of parents of young children aged 30-59 months with moderate to severe LD. The programme lasts for 9 weeks and has shown positive results in small trials outside the United Kingdom, indicating that it is a potentially helpful. However, it needs to be tested within the UK health system before recommendations can be made to roll it out. Level 4 SSTP helps parents understand and manage their child's behaviour and parents may benefit from peer support in a group setting. The investigators shall recruit 258 parents who will be allocated to one of two groups by chance: one will receive SSTP and treatment as usual and the other treatment as usual, a list of resources and the Contact a Family guide to challenging behaviour. Treatment as usual includes support and advice by General Practitioner's or child development teams. The investigators shall use parental reports and observations of child behaviour to examine whether SSTP reduces challenging behaviour at four (short term) and 12 (long term) months after randomisation. They will also ask other caregivers' about the child's behaviour, the child's and the parent's health related quality of life, difficulties with care, parent stress, service use and how the parent has found the intervention using both questionnaires and face to face interviews.The investigators shall interview the service managers and the therapists about their experience of hosting and delivering the intervention. Parents will also be recruited to the Parent Advisory Group to advise about various aspects of the study, e.g. materials, interview topic guides, dissemination. The researchers and clinicians have expertise in LD, child health and early intervention and have conducted several large trials with this population. The trial will last 48 months and will follow all statutory research governance requirements to ensure that it is high quality, safe and ethical.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepping Stones Triple P | Experimental | Behavioral: Level 4 Stepping Stones Triple P (SSTP)Trained practitioners will deliver Level 4 SSTP to parents in 6 weekly group sessions and will also provide 3 telephone of face to face contacts to each participant but they will not be involved in routine care for participants in either arm. Each therapist responsible for delivering SSTP will be trained in the Group Stepping Stones Training and Accreditation programme which includes three training days and a further half day accreditation workshop after 6 weeks. The group sessions not only educate but actively train the parents in skills and the individual consultations aim to facilitate independent problem solving. The learning objectives focus on maintaining behavioural change, using skills within a group learning environment, learning from peers in the group and sharing difficulties or achievements, providing support, considering if more intensive work is required, referring further if needed, talking about risk and protective factors operating within families. |
| Treatment as usual (TAU) | No intervention | –TAU will be available to participants in both arms of the trial. It may include a range of services such as: 1. Health visitor services; 2. Primary care engagement and advice; 3. Potentially some version of early intervention maybe provided by either community paediatric services or Child and Adolescent Mental Health Services, although our understanding is that very little is available for children of this age. 4. Parenting advice and support sessions by carers groups or other third sector organisations. Parents allocated to TAU will receive a list of national and local resources and the Contact a Family guide to challenging behavior with tips and advice on social and health care supports. |
Who may qualify
- Ages
- 30 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: Parents 18 years or over; Child aged 30-59 months at identification;
- Child has moderate to severe intellectual disability (parent reported Adaptive Behaviour Assessment System (ABAS) General Adaptive Functioning 20-69);
- Written informed consent by parent/caregiver;
- Reports of challenging behaviour over a 6-month period but no less than 2 months.
Key exclusion criteria (3 listed)
- Child has mild, profound or no LD on parent reported ABAS;
- Parent/carer has insufficient English language to complete study questionnaires;
- Another sibling is taking part in the study.
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 |
|---|---|---|
| Level 4 Stepping Stones Triple P (SSTP)Stepping Stones Triple P is a system of psychoeducational and behavioural approaches to parenting a child with LD and challenging behaviour that aims to increase parental confidence and skills so that parents are able to manage the child's behavior effectively. SSTP comprises different levels based on increasing family complexity. | Behavioural | Stepping Stones Triple P |
Primary outcome
Child Behaviour Check List (CBCL)
Time frame: 12 months
Children's challenging behaviour will be measured at 12 months post randomisation using the parent completed preschool Child Behaviour Checklist (CBCL)
10 secondary outcomes
Revised Family Observation Schedule (FOS-RIII)
Time frame: 12 months
Child Behaviour Checklist Caregiver-Teacher Report Forms (C-TRF)
Time frame: 12 months
General Health Questionnaire (GHQ)
Time frame: 12 months
Questionnaire on Resources and Stress (QRS-F short form)
Time frame: 12 months
Caregiving Problem Checklist-Difficult Child Behaviour
Time frame: 12 months
Parenting Sense of Competence Scale (PSOC)
Time frame: 12 months
Child and Adolescent Service Use Schedule (CA-SUS)
Time frame: 12 months
Pediatric Quality of Life (PedsQL)
Time frame: 12 months
EuroQoL (EQ-5D)
Time frame: 12 months
Client Satisfaction Questionnaire (CSQ)
Time frame: 4 months
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 21 Apr 2022.
- Derived from this study: PubMed 39045819Ondruskova T, Oulton K, Royston R; EPICC-ID Research Group; Hassiotis A. Process evaluation of a parenting intervention for pre-schoolers with intellectual disabilities who display behaviours that challenge in the UK. J Appl Res Intellect Disabil. 2024 Sep;37(5):e13263. doi: 10.1111/jar.13263.
- Derived from this study: PubMed 38329108Ondruskova T, Royston R, Absoud M, Ambler G, Qu C, Barnes J, Hunter R, Panca M, Kyriakopoulos M, Oulton K, Paliokosta E, Sharma AN, Slonims V, Summerson U, Sutcliffe A, Thomas M, Dhandapani B, Leonard H, Hassiotis A. Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT. Health Technol Assess. 2024 Jan;28(6):1-94. doi: 10.3310/JKTY6144.
- Derived from this study: PubMed 32000729Farris O, Royston R, Absoud M, Ambler G, Barnes J, Hunter R, Kyriakopoulos M, Oulton K, Paliokosta E, Panca M, Paulauskaite L, Poppe M, Ricciardi F, Sharma A, Slonims V, Summerson U, Sutcliffe A, Thomas M, Hassiotis A. Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe intellectual disability (EPICC-ID) study protocol: a multi-centre, parallel-group randomised controlled trial. BMC Psychiatry. 2020 Jan 30;20(1):35. doi: 10.1186/s12888-020-2451-6.
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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.
Angela Hassiotis principal investigator
University College, London
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Level 4 Stepping Stones Triple P (SSTP) in people with Challenging Behaviour, run by University College, London at 4 sites 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 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Child Behaviour Check List (CBCL) (time frame: 12 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 NCT03086876, which also lists 3 linked publications.
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 21 Apr 2022.