Autism Spectrum DisordersGIETSANCT04607616
Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder
A study testing Baseline sessions TAU, Interactive guidance therapy and Developmental and diagnostic assessments in people with Autism Spectrum Disorders, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple… Read more about this study
- Who is it for?
- Ages 18 months to 3 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Baseline sessions TAU, Interactive guidance therapy and Developmental and diagnostic assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesFrance
- Study dates
- 26 Mar 2021to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 18 months to 3 years child at screening
- Child with a diagnosis of Autism Spectrum Disorder (DSM 5) or pervasive Developmental Disorder (ICD 10)
- Child with ADI R and ADOS-2 fulfilling the criteria for TSA / PDD at diagnosis
- Developmental age > 12 months in motility with the Brunet-Lézine test
- Child with availability of parent most present in daily life, only this parent participating directly in play sessions
- Signed Informed consent form by both parents
- Patient affiliated to the health insurance system
Who cannot join
- Level of language in French of parents insufficient to benefit from the care and fill in the questionnaires
- Psychiatric parental pathology interfering with interactions with the child, qualitatively assessed by the referring psychiatrist
- Severe sensory illness of the child (blindness, deafness, degenerative disease)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Saint Eloi
Montpellier, 34000
Hôpital Ville Evrard
Montreuil, 93100
Hôpital Pitié Salpétriere
Paris, 75013
Hôpital Necker Enfants Malades
Paris, 75015
About this study
The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored
Read the detailed description
The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design.
Early Interventions in Autism Spectrum Disorders (ASD) undergo a major development. The investigators identify three generations of early support: 1) Behavioral studies ; 2) Early Intensive Behavioral Interventions (EIBI), inspired by ABA, focused on targeted ASD disorders 3) Naturalistic Behavioral Developmental Behavioral Interventions (NDBI), more ecological, focused on the child's skills.
Among them, methods of video feedback target parental sensitivity (identification, interpretation, response, contingency and synchrony). The VIPP (Video Interactive Positive Parenting) in children less than one year of age, has shown moderate and long term effects on parent-child interaction. The PACT (Preschool Autism Communication Trial) showed immediate and in the long term effects on the synchronization of the parental response, the child initiation, less importantly on the joint attention, and on the autistic symptoms. The dyadic communication allows for changes in autistic symptoms.
Interactive guidance is a brief video-feedback therapy, based on the analysis of "the here and now" with the parent (s), of videotaped interactions with their child. The objective is to strengthen parental skills, their sensitivity, their ability to decipher and respond to the specific needs of their child.
The interest of IGT in the field of ASD, compared to VIPP and PACT, is to offer a standardized feedback intervention adapted to each dyad, according to the child's and parents skills and difficulties, structured on the "here and now" more than on a predetermined sequence of goals.
The investigators use the Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored.
They expect
- to improve the interactive and communicative basic skills of the child, soon after the ASD diagnosis, by accompanying the parents in the identification and understanding of their child's disorders.
- to propose a method highlighting parental skills, in a collaborative and pleasant way
- To increase the parental alliance in the implementation of a tailored intervention for the child
- To facilitate access to healthcare and reduce the parental wandering in the implementation of intervention
- Conditions
- Autism Spectrum Disorders
- Being tested
- Baseline sessions TAU, Interactive guidance therapy, Developmental and diagnostic assessments, Developmental assessment -Parental scales, Qualitative analysis
- Keywords
- Autism Spectrum Disorders, Interactive guidance therapy, Video feed-back
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline sessions TAUBehavioural
TAU consists of sessions lasting around one/one and a half hour ; the consultant is practicing as usual. The interventions focus on child's behavior, parent infant relationship, with moments of play with the child, advices, informations about child development and Autism.
Interactive guidance therapyBehavioural
The objective is to reinforce the identification, deciphering, interpretation, and answer to child's signals by the parent, in order to to promote a synchronous and attuned response to the child's needs.
Sessions last around one/one and a half hour. Parent plays 7-10 minutes with the child, in the presence of the therapist, with toys chosen according to the child's developmental stage. Then therapist proposes an immediate viewing of the play session. The therapist selects short moments of positive interaction. He has determined a " focus ", depending on the play, previous sessions, the child's difficulties and parent's interventions. He accompanies, guides and supports the parent to describe the interaction, the alternance in play, joint attention, shared affect, in a co-construction: the parent discovers the child's and his own skills.
Developmental and diagnostic assessmentsDiagnostic test
MSEL, CARS, ECAR, CIM10, DMS5, ADOS, ADIR
Developmental assessment -Parental scalesBehavioural
Vineland II, IFDC, IDE
Qualitative analysisBehavioural
Interpretative Phenomenological Analysis. Parents' semi structured interview about the Interactive Guidance experience. Qualitative analysis of transcripts (recurrent themes, meta themes).
| Study group | Role | What they receive |
|---|---|---|
| 3 baselines sessions Treatment As Usual (TAU) | Experimental | Patients received 3 baseline sessions before interactive guidance therapy Receives: Behavioral: Baseline sessions TAU; Behavioral: Interactive guidance therapy; Diagnostic Test: Developmental and diagnostic assessments; Behavioral: Developmental assessment -Parental scales; Behavioral: Qualitative analysis |
| 4 baselines sessions TAU | Experimental | Patients received 4 baseline sessions before interactive guidance therapy Receives: Behavioral: Baseline sessions TAU; Behavioral: Interactive guidance therapy; Diagnostic Test: Developmental and diagnostic assessments; Behavioral: Developmental assessment -Parental scales; Behavioral: Qualitative analysis |
| 5 baselines sessions TAU | Experimental | Patients received 5 baseline sessions before interactive guidance therapy Receives: Behavioral: Baseline sessions TAU; Behavioral: Interactive guidance therapy; Diagnostic Test: Developmental and diagnostic assessments; Behavioral: Developmental assessment -Parental scales; Behavioral: Qualitative analysis |
| 6 baselines sessions TAU | Experimental | Patients received 6 baseline sessions before interactive guidance therapy Receives: Behavioral: Baseline sessions TAU; Behavioral: Interactive guidance therapy; Diagnostic Test: Developmental and diagnostic assessments; Behavioral: Developmental assessment -Parental scales; Behavioral: Qualitative analysis |
| 7 baselines sessions TAU | Experimental | Patients received 7 baseline sessions before interactive guidance therapy Receives: Behavioral: Baseline sessions TAU; Behavioral: Interactive guidance therapy; Diagnostic Test: Developmental and diagnostic assessments; Behavioral: Developmental assessment -Parental scales; Behavioral: Qualitative analysis |
| 8 baselines sessions TAU | Experimental | Patients received 8 baseline sessions before interactive guidance therapy Receives: Behavioral: Baseline sessions TAU; Behavioral: Interactive guidance therapy; Diagnostic Test: Developmental and diagnostic assessments; Behavioral: Developmental assessment -Parental scales; Behavioral: Qualitative analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in a joint attention situation
Coordinated Joint Attention (COJ) rate is evaluated during the parents-child play-time
Measured: Up to 15 months
Percentage of time spent in a joint attention situation
Supported Joint Attention (SUJ) rate is evaluated during the parents-child play-time
Measured: Up to 15 months
Secondary outcomes (15)
Parent-child interactive features/ joint attention
- SUJ and COJ rate initiated by child
Measured: Up to 15 months
Parent-child interactive features / DCMA scale
- DCMA: dyadic communication measure in autism
Measured: Up to 15 months
Parent-child interactive features / Parental synchrony
- number of parental responses in synchrony with child
Measured: Up to 15 months
Parent-child interactive features / Communication
- Number conversational turns of speech between the child and the parent
Measured: Up to 15 months
Parent-child interactive features / Initiation of communication
- Initiation of communication by the child with the parent : in proportion to the child's acts of communication
Measured: Up to 15 months
Child development / MSEL
- MSEL : is Mullen Scale of Early Learning evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Measured: Up to 15 months
Child development / CDI
- CDI is Child Development Inventory evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Measured: Up to 15 months
Child development / IFDC
- IFDC is French adaptation of MacArthur-Bates Communicative Development Inventories evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Measured: Up to 15 months
Autistic Symptoms / CARS
CARS is Childhood Autism Rating Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Measured: Up to 15 months
Autistic Symptoms ECAR
ECA R is "Evaluation des comportements autistiques Révisée" Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Measured: Up to 15 months
Autistic Symptoms ADOS-2
ADOS-2 is Autism diagnostic observation Schedule evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Measured: Up to 15 months
Autistic Symptoms ADIR
ADI R is Autism Diagnosis Interview Revised evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Measured: Up to 15 months
Adaptive behavior of the child
Vineland 2 Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Measured: Up to 15 months
Change process
Psychotherapy Process Q-set evaluated at baseline visit 1 and last baseline visit (depend of randomization), guidance session 1 and guidance session 10
Measured: Up to 15 months
Content analysis of guidance session by parent
Targeted interview of parents with the psychologist on the content of guidance session
Measured: At 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start26 Mar 2021
- Primary completion23 May 2022
- Study completionMay 2026 (estimated)
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 Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ville Evrard Hospital, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Benoit QUIROT, MD, Study director, EPS Ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607616
- Sponsor's protocol ID
- APHP180671
- Other IDs
- 2019-A02707-50
- Acronym
- GIETSA
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96.
2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72.
Rusconi-Serpa S, Sancho Rossignol A, McDonough SC. Video feedback in parent-infant treatments. Child Adolesc Psychiatr Clin N Am. 2009 Jul;18(3):735-51. doi: 10.1016/j.chc.2009.02.009.
PubMed 19486848
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04607616
- Acronym / sponsor ID
- GIETSA / APHP180671
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism Spectrum Disorders, Interactive guidance therapy, Video feed-back
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ville Evrard Hospital, URC-CIC Paris Descartes Necker Cochin
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 29 Oct 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.
The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored
Detailed description
The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design.
Early Interventions in Autism Spectrum Disorders (ASD) undergo a major development. The investigators identify three generations of early support: 1) Behavioral studies ; 2) Early Intensive Behavioral Interventions (EIBI), inspired by ABA, focused on targeted ASD disorders 3) Naturalistic Behavioral Developmental Behavioral Interventions (NDBI), more ecological, focused on the child's skills.
Among them, methods of video feedback target parental sensitivity (identification, interpretation, response, contingency and synchrony). The VIPP (Video Interactive Positive Parenting) in children less than one year of age, has shown moderate and long term effects on parent-child interaction. The PACT (Preschool Autism Communication Trial) showed immediate and in the long term effects on the synchronization of the parental response, the child initiation, less importantly on the joint attention, and on the autistic symptoms. The dyadic communication allows for changes in autistic symptoms.
Interactive guidance is a brief video-feedback therapy, based on the analysis of "the here and now" with the parent (s), of videotaped interactions with their child. The objective is to strengthen parental skills, their sensitivity, their ability to decipher and respond to the specific needs of their child.
The interest of IGT in the field of ASD, compared to VIPP and PACT, is to offer a standardized feedback intervention adapted to each dyad, according to the child's and parents skills and difficulties, structured on the "here and now" more than on a predetermined sequence of goals.
The investigators use the Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored.
They expect
- to improve the interactive and communicative basic skills of the child, soon after the ASD diagnosis, by accompanying the parents in the identification and understanding of their child's disorders.
- to propose a method highlighting parental skills, in a collaborative and pleasant way
- To increase the parental alliance in the implementation of a tailored intervention for the child
- To facilitate access to healthcare and reduce the parental wandering in the implementation of intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 3 baselines sessions Treatment As Usual (TAU) | Experimental | Behavioral: Baseline sessions TAU, Behavioral: Interactive guidance therapy, Diagnostic Test: Developmental and diagnostic assessments, Behavioral: Developmental assessment -Parental scales, Behavioral: Qualitative analysisPatients received 3 baseline sessions before interactive guidance therapy |
| 4 baselines sessions TAU | Experimental | Behavioral: Baseline sessions TAU, Behavioral: Interactive guidance therapy, Diagnostic Test: Developmental and diagnostic assessments, Behavioral: Developmental assessment -Parental scales, Behavioral: Qualitative analysisPatients received 4 baseline sessions before interactive guidance therapy |
| 5 baselines sessions TAU | Experimental | Behavioral: Baseline sessions TAU, Behavioral: Interactive guidance therapy, Diagnostic Test: Developmental and diagnostic assessments, Behavioral: Developmental assessment -Parental scales, Behavioral: Qualitative analysisPatients received 5 baseline sessions before interactive guidance therapy |
| 6 baselines sessions TAU | Experimental | Behavioral: Baseline sessions TAU, Behavioral: Interactive guidance therapy, Diagnostic Test: Developmental and diagnostic assessments, Behavioral: Developmental assessment -Parental scales, Behavioral: Qualitative analysisPatients received 6 baseline sessions before interactive guidance therapy |
| 7 baselines sessions TAU | Experimental | Behavioral: Baseline sessions TAU, Behavioral: Interactive guidance therapy, Diagnostic Test: Developmental and diagnostic assessments, Behavioral: Developmental assessment -Parental scales, Behavioral: Qualitative analysisPatients received 7 baseline sessions before interactive guidance therapy |
| 8 baselines sessions TAU | Experimental | Behavioral: Baseline sessions TAU, Behavioral: Interactive guidance therapy, Diagnostic Test: Developmental and diagnostic assessments, Behavioral: Developmental assessment -Parental scales, Behavioral: Qualitative analysisPatients received 8 baseline sessions before interactive guidance therapy |
Who may qualify
- Ages
- 18 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 18 months to 3 years child at screening
- Child with a diagnosis of Autism Spectrum Disorder (DSM 5) or pervasive Developmental Disorder (ICD 10)
- Child with ADI R and ADOS-2 fulfilling the criteria for TSA / PDD at diagnosis
- Developmental age > 12 months in motility with the Brunet-Lézine test
- Child with availability of parent most present in daily life, only this parent participating directly in play sessions
Key exclusion criteria (3 listed)
- Level of language in French of parents insufficient to benefit from the care and fill in the questionnaires
- Psychiatric parental pathology interfering with interactions with the child, qualitatively assessed by the referring psychiatrist
- Severe sensory illness of the child (blindness, deafness, degenerative disease)
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 |
|---|---|---|
| Baseline sessions TAUTAU consists of sessions lasting around one/one and a half hour ; the consultant is practicing as usual. The interventions focus on child's behavior, parent infant relationship, with moments of play with the child, advices, informations about child development and Autism. | Behavioural | 3 baselines sessions Treatment As Usual (TAU), 4 baselines sessions TAU, 5 baselines sessions TAU, 6 baselines sessions TAU, 7 baselines sessions TAU, 8 baselines sessions TAU |
| Interactive guidance therapyThe objective is to reinforce the identification, deciphering, interpretation, and answer to child's signals by the parent, in order to to promote a synchronous and attuned response to the child's needs. Sessions last around one/one and a half hour. Parent plays 7-10 minutes with the child, in the presence of the therapist, with toys chosen according to the child's developmental stage. Then therapist proposes an immediate viewing of the play session. The therapist selects short moments of positive interaction. He has determined a " focus ", depending on the play, previous sessions, the child's difficulties and parent's interventions. He accompanies, guides and supports the parent to describe the interaction, the alternance in play, joint attention, shared affect, in a co-construction: the parent discovers the child's and his own skills. | Behavioural | 3 baselines sessions Treatment As Usual (TAU), 4 baselines sessions TAU, 5 baselines sessions TAU, 6 baselines sessions TAU, 7 baselines sessions TAU, 8 baselines sessions TAU |
| Developmental and diagnostic assessmentsMSEL, CARS, ECAR, CIM10, DMS5, ADOS, ADIR | Diagnostic test | 3 baselines sessions Treatment As Usual (TAU), 4 baselines sessions TAU, 5 baselines sessions TAU, 6 baselines sessions TAU, 7 baselines sessions TAU, 8 baselines sessions TAU |
| Developmental assessment -Parental scalesVineland II, IFDC, IDE | Behavioural | 3 baselines sessions Treatment As Usual (TAU), 4 baselines sessions TAU, 5 baselines sessions TAU, 6 baselines sessions TAU, 7 baselines sessions TAU, 8 baselines sessions TAU |
| Qualitative analysisInterpretative Phenomenological Analysis. Parents' semi structured interview about the Interactive Guidance experience. Qualitative analysis of transcripts (recurrent themes, meta themes). | Behavioural | 3 baselines sessions Treatment As Usual (TAU), 4 baselines sessions TAU, 5 baselines sessions TAU, 6 baselines sessions TAU, 7 baselines sessions TAU, 8 baselines sessions TAU |
Primary outcome
Percentage of time spent in a joint attention situation
Time frame: Up to 15 months
Coordinated Joint Attention (COJ) rate is evaluated during the parents-child play-time
Percentage of time spent in a joint attention situation
Time frame: Up to 15 months
Supported Joint Attention (SUJ) rate is evaluated during the parents-child play-time
15 secondary outcomes
Parent-child interactive features/ joint attention
Time frame: Up to 15 months
Parent-child interactive features / DCMA scale
Time frame: Up to 15 months
Parent-child interactive features / Parental synchrony
Time frame: Up to 15 months
Parent-child interactive features / Communication
Time frame: Up to 15 months
Parent-child interactive features / Initiation of communication
Time frame: Up to 15 months
Child development / MSEL
Time frame: Up to 15 months
Child development / CDI
Time frame: Up to 15 months
Child development / IFDC
Time frame: Up to 15 months
Autistic Symptoms / CARS
Time frame: Up to 15 months
Autistic Symptoms ECAR
Time frame: Up to 15 months
Autistic Symptoms ADOS-2
Time frame: Up to 15 months
Autistic Symptoms ADIR
Time frame: Up to 15 months
Adaptive behavior of the child
Time frame: Up to 15 months
Change process
Time frame: Up to 15 months
Content analysis of guidance session by parent
Time frame: At 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96.
- Background2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72.
- Background: PubMed 19486848Rusconi-Serpa S, Sancho Rossignol A, McDonough SC. Video feedback in parent-infant treatments. Child Adolesc Psychiatr Clin N Am. 2009 Jul;18(3):735-51. doi: 10.1016/j.chc.2009.02.009.
- 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.
Benoit QUIROT, MD study director
EPS Ville Evrard
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline sessions TAU, Interactive guidance therapy and Developmental and diagnostic assessments in people with Autism Spectrum Disorders, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of time spent in a joint attention situation (time frame: Up to 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607616, 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 6 May 2026.