Autism Spectrum DisorderFSNCT04358484
Implementation of Incredible Years for Autism and Language Delay Program in Spain
A study testing Incredible Years - ASD and Language Delay® in people with Autism Spectrum Disorder and Language Delay, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
Children with autism spectrum disorders (ASD) usually present coexisting problems in emotion and behavior regulation, similarly as premature children with communication or socialization difficulties. Caring for children with neurodevelopmental difficulties is an important stressor for parents. Read more about this study
- Who is it for?
- Ages 24 to 71 months
- Conditions the study is for
- Autism Spectrum Disorder, Language Delay, Prematurity
- What is being tested?
- Incredible Years - ASD and Language Delay®
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2020to May 2021
- 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 24 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents who have signed the Informed Consent.
- Parents of children diagnosed with ASD.
- Parents of children between the ages of 2 and 5 years, 11months.
- Fluency in Spanish.
- Parents who have signed the informed consent.
- Parents of children born with gestational age less than 37 weeks.
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- Parents of children with communication or socialization difficulties (Vineland-III scores 1SD below the mean in any of the communication or socialization subdomains).
- Parents of children between the ages of 2 and 5 years, 11months.
- Fluency in Spanish
Who cannot join
- Attending another structured/manualized parenting program (focused on improving strategies for parents to help their children with behavioral and emotion regulation) at the time of the study.
- Parents of looked after children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for a Randomized Pilot Study (FIRST STEPS): Implementation of the Incredible Years-ASLD® Program in Spanish Preschoolers With Autism and Premature Children With Communication or Socialization Difficulties
Children with autism spectrum disorders (ASD) usually present coexisting problems in emotion and behavior regulation, similarly as premature children with communication or socialization difficulties. Caring for children with neurodevelopmental difficulties is an important stressor for parents. Therefore, it is essential that families are offered evidence-based interventions at an early stage within the public health service. Group therapy is a cost-effective intervention that can help parents of children diagnosed with autism and those born prematurely. The Incredible Years - ASLD program is an example of this sort of therapy, consisting of a group intervention for parents of preschool children with a diagnosis of ASD or Language Delay. In Spain, group interventions for children with ASD and preterm children presenting with Language Delay are scarce in the public health service. The Incredible Years - ASLD program has not been translated into Spanish and it has not been previously implemented in our country.
The Incredible Years - ASLD group intervention will be carried out in three public Healthcare centers. It is intended to recruit 72 patients diagnosed with ASD or premature children with communication or socialization difficulties, which will be randomized to an Intervention Group or to Treatment as Usual (TAU) Group. The Intervention Group will receive fourteen sessions of the Incredible Years - ASLD program in addition to Treatment as Usual (TAU). In terms of clinical implications, this randomized pilot study could demonstrate the feasibility of implementing this intervention in the regular clinical settings within the Spanish public health service and could be a first step for future controlled studies that demonstrate its effectiveness.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder involving social communication disturbances and a restricted pattern of interests, present before age 3. Premature infants are at particular risk for neurodevelopmental disturbances, such as language delay, difficulties in social communication and ASD.
ASD is often associated with behavior difficulties, emotion regulation difficulties, psychiatric comorbidities and a dysfunctional response to sensory stimuli. Children with premature birth also present difficulties related to emotion and behavior regulation.
Due to these difficulties, caring for children with neurodevelopmental disorders can be very stressful for parents, which could in turn lead to lower effectiveness of interventions and greater mental health difficulties in parents.
Therefore, parenting interventions should not only address children's difficulties, these interventions should also aim to provide support for parents. Since no interventions have specifically addressed these two aspects in the treatment of neurodevelopmental disorders, several therapies have been adapted for this population. This is the case of the intervention at hand: Incredible Years - ASD and Language Delay (IY-ASLD).
In this intervention, in addition to learning strategies to promote the development of skills in children, parents receive support from other parents and from the therapists. The effectiveness of the Incredible Years program has been widely demonstrated in multiple randomized clinical trials, showing an improvement in terms of parental stress levels, depression and parental coping, as well as in children behavior difficulties. Incredible Years is also considered an evidence-based intervention according to the NICE guidelines.
The Incredible Years Program has been adapted for parents of children between ages 2 and 5 diagnosed with ASD, presenting ASD symptoms or language delay. A pilot study conducted in the UK has demonstrated high levels of acceptability, as well as a decrease in levels of parental stress associated with the care of their children. The results of a pilot randomized clinical trial in Wales have been recently published, supporting the feasibility of this intervention in the NHS and showing good levels of acceptability and fidelity to the program and compliance. The Incredible Years - ASLD Program has not been implemented in Spain and to the best of our knowledge it has not been used with parents of children of premature birth with communication and socialization difficulties.
This study aims to demonstrate the feasibility of reliably implementing the IY-ASLD parental program in different outpatient services of the Spanish public health service, as well as exploring its effectiveness in terms of reducing parental distress and improving children outcomes.
The IY - ASLD program will be implemented in three sites across Spain: Hospital Sant Joan de Déu Barcelona (HSJD), Hospital General Universitario Gregorio Marañón (HGUGM) and Hospital Materno Infantil (HMI) de Málaga. In the first site the program will be implemented with parents of premature children with communication and socialization impairment, and in the other two sites the program will be applied with parents of children diagnosed with ASD. The IY-ASLD program will consist of 22 weekly online group sessions for parents of children between 2-5 years of age. The sessions will be conducted by a therapist and a co-therapist, both trained in the program. A total of n = 72 parents (48 with ASD children and 24 with premature children) will be recruited and will be randomized to a control group (36 parents: 24 with ASD children and 12 with premature children) or group intervention (36 parents: 24 with ASD children and 12 with premature children).
- Conditions
- Autism Spectrum Disorder, Language Delay, Prematurity
- Being tested
- Incredible Years - ASD and Language Delay®
- Keywords
- Autism Spectrum Disorder, Language Delay, Prematurity, Incredible Years, Parenting Intervention
- Medical subject headings
- Autism Spectrum Disorder, Language Development Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incredible Years - ASD and Language Delay®Behavioural
The IY - ASLD Program will consist of 22 weekly online group sessions for parents of children between 2-5 years of age with symptoms or a diagnosis of ASD or delayed language acquisition. The program will be conducted by a therapist and a co-therapist, trained in the model.
Fidelity to the intervention will be assessed in accordance with the regulations of the program. All of the therapists and co-therapists will be trained in the intervention by accredited trainers. The three main therapists will be supervised by accredited supervisors of the IY Program, seeking accreditation in the intervention. As the intervention IY - ASLD has not been translated into Spanish, the English materials will be used with simultaneous translation into Spanish language.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants attend The Incredible Years - ASLD parenting intervention and continue to receive usual care at their healthcare center Receives: Behavioral: Incredible Years - ASD and Language Delay® |
| Treatment As Usual (TAU) Group | No intervention | Participants continue to receive usual care at their Healthcare Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Program Parent Final Satisfaction Questionnaire
Questionnaire for parents assessing their satisfaction with the IY-ASLD Program received.
Measured: Administered to the intervention group at treatment completion (approximately 22 weeks after baseline).
Register sheet of attendance
Register of weekly attendance, aimed to determine levels of compliance with the intervention.
Measured: Administered to the intervention group weekly throughout treatment (22 weeks total)
Autism Program Parent Weekly Evaluation.
Questionnaire assessing levels of satisfaction with each therapy session.This survey was specifically developed for the Incredible Years Program and can be found in the Incredible Years manual
Measured: Administered to the intervention group weekly throughout treatment (22 weeks total)
Incredible Years® Parent Strategies Questionnaire for Children with Autism (2-5 years)
Questionnaire assessing type of parental strategies specifically aimed at helping children with ASD.
Measured: Administered to the intervention group. Baseline (prior to programme initiation) and immediately after the intervention.
Secondary outcomes (4)
Parental Stress Index (PSI-SF) by Abidin.
Inventory assessing levels of parental stress regarding the care of their children.
Measured: Administered to both arms.First assessment before the groups randomization, pre-intervention assessment just before the programme initiation (due to the delay of the intervention because the COVID-19 pandemic), and immediately after the intervention.
Beck Depression Inventory (BDI)
Inventory of depressive symptoms for adults, reported by parents.
Measured: Administered to both arms. First assessment before the groups randomization, pre-intervention assessment just before the programme initiation (due to the delay of the intervention because the COVID-19 pandemic), and immediately after the intervention.
Autism Specify Five Minutes Speech Sample - ASFMSS
It measures the construct Expressed emotion in parents of children with neurodevelopmental difficulties.
Measured: Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.
Alabama Parenting Questionnaire Preschool revision (APQ-Pr).
It assesses parenting practices, including positive, inconsistent and punitive parenting styles.
Measured: Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start2 Jan 2020
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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 will be recruited from three different sites across Spain: HSJD Barcelona, HGUGM Madrid and HMI Málaga. The first site will recruit parents of premature children and the other two sites will recruit parents of children diagnosed with ASD. Participants who meet inclusion criteria and sign the informed consent will complete a pre-intervention assessment. Families will be randomized to the intervention arm or to the treatment as usual (TAU) group, using stratified randomization regarding cognitive level. Those in the intervention arm will attend the IY-ASLD program and those in the TAU group will continue to receive usual care in their healthcare centers. Due to the COVID-19 pandemic the intervention has been postponed and there will be a re-assessment of parental stress and depressive symptoms in both groups just before starting the intervention. After the IY-ASLD is finished, participants in both groups will complete a post-intervention assessment.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laia Villalta, Medicine, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358484
- Sponsor's protocol ID
- PIC-220-19
- Acronym
- FS
- Status last verified
- Feb 2021
- First submitted
- 20 Mar 2020
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valencia-Agudo F, Villalta-Macia L, Urbiola-Merina E, Garriz-Luis A, Lopez-Moreno L, Rivas-Rodriguez M, Parellada M, Romero-Gonzalez M. FIRST STEPS: A Pilot Randomized Study Analyzing the Preliminary Efficacy of the Incredible Years for Autism Spectrum and Language Delays (IY-ASLD(R)). J Autism Dev Disord. 2026 Mar 18. doi: 10.1007/s10803-026-07268-6. Online ahead of print.
PubMed 41849025Valencia F, Urbiola E, Romero-Gonzalez M, Navas I, Elias M, Garriz A, Ramirez A, Villalta L. Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD(R) program in Spanish children with autism and preterm children with communication and/or socialization difficulties. Trials. 2021 Apr 20;22(1):291. doi: 10.1186/s13063-021-05229-1.
PubMed 33879224
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Randomized Pilot Study (FIRST STEPS): Implementation of the Incredible Years-ASLD® Program in Spanish Preschoolers With Autism and Premature Children With Communication or Socialization Difficulties
- ClinicalTrials.gov ID
- NCT04358484
- Acronym / sponsor ID
- FS / PIC-220-19
- Conditions
- Autism Spectrum Disorder, Language Delay, Prematurity
- Keywords
- Autism Spectrum Disorder, Language Delay, Prematurity, Incredible Years, Parenting Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 24 Apr 2020 (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 autism spectrum disorders (ASD) usually present coexisting problems in emotion and behavior regulation, similarly as premature children with communication or socialization difficulties. Caring for children with neurodevelopmental difficulties is an important stressor for parents. Therefore, it is essential that families are offered evidence-based interventions at an early stage within the public health service. Group therapy is a cost-effective intervention that can help parents of children diagnosed with autism and those born prematurely. The Incredible Years - ASLD program is an example of this sort of therapy, consisting of a group intervention for parents of preschool children with a diagnosis of ASD or Language Delay. In Spain, group interventions for children with ASD and preterm children presenting with Language Delay are scarce in the public health service. The Incredible Years - ASLD program has not been translated into Spanish and it has not been previously implemented in our country.
The Incredible Years - ASLD group intervention will be carried out in three public Healthcare centers. It is intended to recruit 72 patients diagnosed with ASD or premature children with communication or socialization difficulties, which will be randomized to an Intervention Group or to Treatment as Usual (TAU) Group. The Intervention Group will receive fourteen sessions of the Incredible Years - ASLD program in addition to Treatment as Usual (TAU). In terms of clinical implications, this randomized pilot study could demonstrate the feasibility of implementing this intervention in the regular clinical settings within the Spanish public health service and could be a first step for future controlled studies that demonstrate its effectiveness.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder involving social communication disturbances and a restricted pattern of interests, present before age 3. Premature infants are at particular risk for neurodevelopmental disturbances, such as language delay, difficulties in social communication and ASD.
ASD is often associated with behavior difficulties, emotion regulation difficulties, psychiatric comorbidities and a dysfunctional response to sensory stimuli. Children with premature birth also present difficulties related to emotion and behavior regulation.
Due to these difficulties, caring for children with neurodevelopmental disorders can be very stressful for parents, which could in turn lead to lower effectiveness of interventions and greater mental health difficulties in parents.
Therefore, parenting interventions should not only address children's difficulties, these interventions should also aim to provide support for parents. Since no interventions have specifically addressed these two aspects in the treatment of neurodevelopmental disorders, several therapies have been adapted for this population. This is the case of the intervention at hand: Incredible Years - ASD and Language Delay (IY-ASLD).
In this intervention, in addition to learning strategies to promote the development of skills in children, parents receive support from other parents and from the therapists. The effectiveness of the Incredible Years program has been widely demonstrated in multiple randomized clinical trials, showing an improvement in terms of parental stress levels, depression and parental coping, as well as in children behavior difficulties. Incredible Years is also considered an evidence-based intervention according to the NICE guidelines.
The Incredible Years Program has been adapted for parents of children between ages 2 and 5 diagnosed with ASD, presenting ASD symptoms or language delay. A pilot study conducted in the UK has demonstrated high levels of acceptability, as well as a decrease in levels of parental stress associated with the care of their children. The results of a pilot randomized clinical trial in Wales have been recently published, supporting the feasibility of this intervention in the NHS and showing good levels of acceptability and fidelity to the program and compliance. The Incredible Years - ASLD Program has not been implemented in Spain and to the best of our knowledge it has not been used with parents of children of premature birth with communication and socialization difficulties.
This study aims to demonstrate the feasibility of reliably implementing the IY-ASLD parental program in different outpatient services of the Spanish public health service, as well as exploring its effectiveness in terms of reducing parental distress and improving children outcomes.
The IY - ASLD program will be implemented in three sites across Spain: Hospital Sant Joan de Déu Barcelona (HSJD), Hospital General Universitario Gregorio Marañón (HGUGM) and Hospital Materno Infantil (HMI) de Málaga. In the first site the program will be implemented with parents of premature children with communication and socialization impairment, and in the other two sites the program will be applied with parents of children diagnosed with ASD. The IY-ASLD program will consist of 22 weekly online group sessions for parents of children between 2-5 years of age. The sessions will be conducted by a therapist and a co-therapist, both trained in the program. A total of n = 72 parents (48 with ASD children and 24 with premature children) will be recruited and will be randomized to a control group (36 parents: 24 with ASD children and 12 with premature children) or group intervention (36 parents: 24 with ASD children and 12 with premature children).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be recruited from three different sites across Spain: HSJD Barcelona, HGUGM Madrid and HMI Málaga. The first site will recruit parents of premature children and the other two sites will recruit parents of children diagnosed with ASD. Participants who meet inclusion criteria and sign the informed consent will complete a pre-intervention assessment. Families will be randomized to the intervention arm or to the treatment as usual (TAU) group, using stratified randomization regarding cognitive level. Those in the intervention arm will attend the IY-ASLD program and those in the TAU group will continue to receive usual care in their healthcare centers. Due to the COVID-19 pandemic the intervention has been postponed and there will be a re-assessment of parental stress and depressive symptoms in both groups just before starting the intervention. After the IY-ASLD is finished, participants in both groups will complete a post-intervention assessment.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Incredible Years - ASD and Language Delay®Participants attend The Incredible Years - ASLD parenting intervention and continue to receive usual care at their healthcare center |
| Treatment As Usual (TAU) Group | No intervention | –Participants continue to receive usual care at their Healthcare Center |
Who may qualify
- Ages
- 24 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Parents who have signed the Informed Consent.
- Parents of children diagnosed with ASD.
- Parents of children between the ages of 2 and 5 years, 11months.
- Fluency in Spanish.
- Parents who have signed the informed consent.
Key exclusion criteria (2 listed)
- Attending another structured/manualized parenting program (focused on improving strategies for parents to help their children with behavioral and emotion regulation) at the time of the study.
- Parents of looked after children.
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 |
|---|---|---|
| Incredible Years - ASD and Language Delay®The IY - ASLD Program will consist of 22 weekly online group sessions for parents of children between 2-5 years of age with symptoms or a diagnosis of ASD or delayed language acquisition. The program will be conducted by a therapist and a co-therapist, trained in the model. Fidelity to the intervention will be assessed in accordance with the regulations of the program. All of the therapists and co-therapists will be trained in the intervention by accredited trainers. The three main therapists will be supervised by accredited supervisors of the IY Program, seeking accreditation in the intervention. As the intervention IY - ASLD has not been translated into Spanish, the English materials will be used with simultaneous translation into Spanish language. | Behavioural | Intervention Group |
Primary outcome
Autism Program Parent Final Satisfaction Questionnaire
Time frame: Administered to the intervention group at treatment completion (approximately 22 weeks after baseline).
Questionnaire for parents assessing their satisfaction with the IY-ASLD Program received.
Register sheet of attendance
Time frame: Administered to the intervention group weekly throughout treatment (22 weeks total)
Register of weekly attendance, aimed to determine levels of compliance with the intervention.
Autism Program Parent Weekly Evaluation.
Time frame: Administered to the intervention group weekly throughout treatment (22 weeks total)
Questionnaire assessing levels of satisfaction with each therapy session.This survey was specifically developed for the Incredible Years Program and can be found in the Incredible Years manual
Incredible Years® Parent Strategies Questionnaire for Children with Autism (2-5 years)
Time frame: Administered to the intervention group. Baseline (prior to programme initiation) and immediately after the intervention.
Questionnaire assessing type of parental strategies specifically aimed at helping children with ASD.
4 secondary outcomes
Parental Stress Index (PSI-SF) by Abidin.
Time frame: Administered to both arms.First assessment before the groups randomization, pre-intervention assessment just before the programme initiation (due to the delay of the intervention because the COVID-19 pandemic), and immediately after the intervention.
Beck Depression Inventory (BDI)
Time frame: Administered to both arms. First assessment before the groups randomization, pre-intervention assessment just before the programme initiation (due to the delay of the intervention because the COVID-19 pandemic), and immediately after the intervention.
Autism Specify Five Minutes Speech Sample - ASFMSS
Time frame: Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.
Alabama Parenting Questionnaire Preschool revision (APQ-Pr).
Time frame: Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Derived from this study: PubMed 41849025Valencia-Agudo F, Villalta-Macia L, Urbiola-Merina E, Garriz-Luis A, Lopez-Moreno L, Rivas-Rodriguez M, Parellada M, Romero-Gonzalez M. FIRST STEPS: A Pilot Randomized Study Analyzing the Preliminary Efficacy of the Incredible Years for Autism Spectrum and Language Delays (IY-ASLD(R)). J Autism Dev Disord. 2026 Mar 18. doi: 10.1007/s10803-026-07268-6. Online ahead of print.
- Derived from this study: PubMed 33879224Valencia F, Urbiola E, Romero-Gonzalez M, Navas I, Elias M, Garriz A, Ramirez A, Villalta L. Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD(R) program in Spanish children with autism and preterm children with communication and/or socialization difficulties. Trials. 2021 Apr 20;22(1):291. doi: 10.1186/s13063-021-05229-1.
- 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.
Laia Villalta, Medicine principal investigator
Fundació Sant Joan de Déu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incredible Years - ASD and Language Delay® in people with Autism Spectrum Disorder and Language Delay, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 9 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: status not confirmed, as of the sponsor's last update on 8 Feb 2021. 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 Spain. 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?
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?
Autism Program Parent Final Satisfaction Questionnaire (time frame: Administered to the intervention group at treatment completion (approximately 22 weeks after baseline).). The study lists 4 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 NCT04358484, which also lists 2 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 8 Feb 2021.