Autism Spectrum DisorderIFPADNCT04244721
Effectiveness of a Parent-mediated Intervention With PACT on Children With ASD
A study testing Preschool Autism Communication Therapy (PACT) and Treatment As Usual (TAU) in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Autism Spectrum Disorder (ASD) is a neuro-developmental disorders. There are different types of interventions. Among these interventions Early Start Denver Model (ESDM) and Preschool Autism Communication Therapy (PACT) have proved efficacy at short and long term. Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Preschool Autism Communication Therapy (PACT) and Treatment As Usual (TAU)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to Aug 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 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with autism Spectrum disorder
- Symptoms in autism with a severity superior to 4 as measure by ADOS-2
- Positive ADI (Autism Diagnostic Interview)
- Diagnostic done by a multidisciplinary team
- Nonverbal IQ above 12 months Having health assurance
Who cannot join
- For the child
- Child with a twin brother or sister with ASD or having a brother or sister already included in this study
- Epilepsy requiring medication
- Severe hearing or visual impairment
- Identification of a genetic anomaly causes participation in the intervention or validity of the data (determined by the principal investigator on a case-by-case basis)
- For the parents
Show all 13Show fewer
- Severe hearing or visual impairment
- Severe psychiatric disorder
- Unstable somatic disorders preventing intervention
- Lack of Internet access
- Parent not available for regular follow-up
- Opposition of one parent to the child's participation in a study
- Already receiving PACT therapy or any other intensive intervention (e.g. Denver)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Vinatier
Bron, 69678
GEOFFRAY Marie-Maude, PhD, +33 (0)4 72 75 53 24, marie-maude.geoffray@ch-le-vinatier.fr
Olivia Dr FEBVEY-COMBES, 0472115162 ext. +33, olivia.febvey-combes@chu-lyon.fr
About this study
Official title: Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children With ASD
Autism Spectrum Disorder (ASD) is a neuro-developmental disorders. There are different types of interventions. Among these interventions Early Start Denver Model (ESDM) and Preschool Autism Communication Therapy (PACT) have proved efficacy at short and long term. PACT is the therapy with the highest evidences when Parents delivered the intervention themselves.
Read the detailed description
In PACT, parents are guided, generally in face to face, by a professional to improve the synchrony and communication with their children with ASD. Then, it is recommended to the parents to practice the therapy daily at home. In France, this type of early intervention is poorly developed and is only accessible in specialized centers located in large urban centers. Guiding parents by videoconferencing could make this intervention accessible to families in undeserved areas. The objective of this study is to evaluate the effectiveness of a PACT intervention delivered by parents and guided by videoconferencing, on the autism in their children with ASD, aged 18 to 36 months at the inclusion.
This is a mixed (quantitative and qualitative), multicenter, controlled, randomized, open-label study, comparing a group of children receiving usual care and one of whose parents is trained and accompanied by videoconferencing to developmental techniques as described in the PACT, to a group of children benefiting only from the usual care provided by the community. The primary endpoint was the severity of autism measured with the ADOS-2 (2012 Autism Diagnostic Observation Schedule) severity score (CSS) at 12 months. A total of 212 children will be included in the study (106 / group).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Preschool Autism Communication Therapy (PACT), Treatment As Usual (TAU)
- Keywords
- interventions Early Start Denver Model (ESDM), Preschool Autism Communication Therapy (PACT)
- 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.
Preschool Autism Communication Therapy (PACT)Other
Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child.
Children will receive therapies available in the community as speech language therapist or occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| a group of children receiving the usual therapy (TAU) | Sham comparator | Children will receive therapies available in the community as speech language therapist or occupational therapist. Receives: Other: Treatment As Usual (TAU) |
| a group of children receiving TAU plus the PACT intervention. | Experimental | Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child. Receives: Other: Preschool Autism Communication Therapy (PACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism severity
Change between baseline and 12 months in the overall raw score at ADOS-2 (Autism Diagnostic Observation Schedule version 2), Module 1
Measured: 12 months
Secondary outcomes (8)
Social Interactions of the child
Social Interactions measured with the total score of the BOSCC (Brief Observation of Social Communication Change).
The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behavior, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behavior, and anxious behaviors. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms.
Measured: 6 and 12 months
Parent-child synchrony and initiative in communication
Parent-child synchrony and initiative in communication measure with DCMA (Dyadic Communication Measure for autism)
Measured: 6 and 12 months
Number of words produced by the child
Number of words produced by the child measured with global score of the french scale " Développement du Langage de Production en Français " (DLPF)
Measured: 12 months
Number of words produced by the child
Number of words produced by the child measured with global score of the Mullen Scale of early learning (MSEL)
Measured: 12 months
Adaptative behavior
Adaptative behavior measured with VABS (Vineland Adaptative Behaviour Scales 2).
The Vineland Adaptive Behavior Scales (VABS; Sparrow et al., 1984) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
Measured: 12 months
Autism Family Experience
Measured with the questionnaire Autism Family Experience. The Autism Family Experience Questionnaire (AFEQ) is a parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. The AFEQ included both positively and negatively worded statements and is scored on an order scale: 1 = always to 5 = never, with an option for "Not Applicable". 4 domains are evaluated : experience of being a parent, family life, child development understanding and social relationships, child symptoms.A higher score means a worse outcome.
Measured: 12 months
Characteristics of the parents
Measured with General Health Questionnaire (GHQ-28). The GHQ-28 is a 28-item self-report used to psychological stress. The GHQ focuses on two main classes of phenomena: 1) inability to carry out one's normal healthy functions; and 2) emergence of new phenomena that are distressing.
It consists of 28 items, divided into 4 sub-scales. It contains 4 sub-scales: A (somatic symptoms), B (anxiety/insomnia), C (social dysfunction), and D (severe depression). There are 4 possible answers to each question. The Likert scoring system assigns a value from 0 to 3 to each of the 4 possible answers. A higher score means a worse outcome.
Measured: 12 months
Characteristics of the parents
Measured with ISP (Indice of Parental Stress). A self-report inventory designed to measure the overall level of parenting stress an individual is experiencing and it examine stressors associated specifically with the parental role and do not include stresses associated with other life roles and events. The PSI-SR has strong psychometric properties and has been used in a number of studies of autism and parent training. It contains 36 items, each rated on a five-point Likert scale (1-5), with higher scores indicative of more parenting stress and includes Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC) sub-scales.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start30 Jun 2020
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (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 Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Model description
- To make the comparison between the two groups on autism symptoms outcome measured with ADOS-2, with a power of 80% and an improvement of 0.6 points, we need 198 children (99 per group). After taking into account of a 20% consensual withdrawals and poor compliance with PACT, 238 children (119 per group) will be required. Each center will therefore have to include 50 children during the inclusion period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244721
- Sponsor's protocol ID
- 2018-A02516-49
- Acronym
- IFPAD
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2020
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jurek L, Occelli P, Denis A, Amestoy A, Maffre T, Dauchez T, Oreve MJ, Baghdadli A, Schroder C, Jay A, Zelmar A, Revah-Levy A, Gallifet N, Aldred C, Garg S, Green J, Touzet S, Geoffray MM; IFPAD study group. Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol. BMJ Open. 2021 Apr 7;11(4):e044669. doi: 10.1136/bmjopen-2020-044669.
PubMed 33827837
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children With ASD
- ClinicalTrials.gov ID
- NCT04244721
- Acronym / sponsor ID
- IFPAD / 2018-A02516-49
- Conditions
- Autism Spectrum Disorder
- Keywords
- interventions Early Start Denver Model (ESDM), Preschool Autism Communication Therapy (PACT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Jan 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.
Autism Spectrum Disorder (ASD) is a neuro-developmental disorders. There are different types of interventions. Among these interventions Early Start Denver Model (ESDM) and Preschool Autism Communication Therapy (PACT) have proved efficacy at short and long term. PACT is the therapy with the highest evidences when Parents delivered the intervention themselves.
Detailed description
In PACT, parents are guided, generally in face to face, by a professional to improve the synchrony and communication with their children with ASD. Then, it is recommended to the parents to practice the therapy daily at home. In France, this type of early intervention is poorly developed and is only accessible in specialized centers located in large urban centers. Guiding parents by videoconferencing could make this intervention accessible to families in undeserved areas. The objective of this study is to evaluate the effectiveness of a PACT intervention delivered by parents and guided by videoconferencing, on the autism in their children with ASD, aged 18 to 36 months at the inclusion.
This is a mixed (quantitative and qualitative), multicenter, controlled, randomized, open-label study, comparing a group of children receiving usual care and one of whose parents is trained and accompanied by videoconferencing to developmental techniques as described in the PACT, to a group of children benefiting only from the usual care provided by the community. The primary endpoint was the severity of autism measured with the ADOS-2 (2012 Autism Diagnostic Observation Schedule) severity score (CSS) at 12 months. A total of 212 children will be included in the study (106 / group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- To make the comparison between the two groups on autism symptoms outcome measured with ADOS-2, with a power of 80% and an improvement of 0.6 points, we need 198 children (99 per group). After taking into account of a 20% consensual withdrawals and poor compliance with PACT, 238 children (119 per group) will be required. Each center will therefore have to include 50 children during the inclusion period.
| Arm | Type | Receives |
|---|---|---|
| a group of children receiving the usual therapy (TAU) | Sham comparator | Other: Treatment As Usual (TAU)Children will receive therapies available in the community as speech language therapist or occupational therapist. |
| a group of children receiving TAU plus the PACT intervention. | Experimental | Other: Preschool Autism Communication Therapy (PACT)Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child with autism Spectrum disorder
- Symptoms in autism with a severity superior to 4 as measure by ADOS-2
- Positive ADI (Autism Diagnostic Interview)
- Diagnostic done by a multidisciplinary team
- Nonverbal IQ above 12 months Having health assurance
Key exclusion criteria (13 listed)
- For the child
- Child with a twin brother or sister with ASD or having a brother or sister already included in this study
- Epilepsy requiring medication
- Severe hearing or visual impairment
- Identification of a genetic anomaly causes participation in the intervention or validity of the data (determined by the principal investigator on a case-by-case basis)
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 |
|---|---|---|
| Preschool Autism Communication Therapy (PACT)Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child. | Other | a group of children receiving TAU plus the PACT intervention. |
| Treatment As Usual (TAU)Children will receive therapies available in the community as speech language therapist or occupational therapist. | Other | a group of children receiving the usual therapy (TAU) |
Primary outcome
Autism severity
Time frame: 12 months
Change between baseline and 12 months in the overall raw score at ADOS-2 (Autism Diagnostic Observation Schedule version 2), Module 1
8 secondary outcomes
Social Interactions of the child
Time frame: 6 and 12 months
Parent-child synchrony and initiative in communication
Time frame: 6 and 12 months
Number of words produced by the child
Time frame: 12 months
Number of words produced by the child
Time frame: 12 months
Adaptative behavior
Time frame: 12 months
Autism Family Experience
Time frame: 12 months
Characteristics of the parents
Time frame: 12 months
Characteristics of the parents
Time frame: 12 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 28 Jul 2025.
- Derived from this study: PubMed 33827837Jurek L, Occelli P, Denis A, Amestoy A, Maffre T, Dauchez T, Oreve MJ, Baghdadli A, Schroder C, Jay A, Zelmar A, Revah-Levy A, Gallifet N, Aldred C, Garg S, Green J, Touzet S, Geoffray MM; IFPAD study group. Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol. BMJ Open. 2021 Apr 7;11(4):e044669. doi: 10.1136/bmjopen-2020-044669.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preschool Autism Communication Therapy (PACT) and Treatment As Usual (TAU) in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. 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 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. Some participants in this study may receive a placebo. 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?
Contact Lydie SARTELET (0437915531 ext. +33, lydie.sartelet@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism severity (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 NCT04244721, 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 28 Jul 2025.