Abusive Head TraumaVEAVE IVNCT07735780
Knowledge and Intentions of French Adults Regarding Abusive Head Trauma in Infants: An Online Survey
An observational study of Abusive Head Trauma, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Abusive head trauma (AHT) is a leading cause of infant mortality and long-term neurodevelopmental disability, yet existing prevention programmes have shown limited effectiveness in reducing its incidence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abusive Head Trauma
- How many people
- 3,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Oct 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited through a collaboration with IPSOS BVA, a survey research organization, using a pre-existing online panel designed to be representative of the French adult general population (based on quotas), as well as social media for supplementation in one subsample. Panel members have previously provided informed consent to participate in surveys on a broad range of topics, including health-related subjects. We will recruit 3000 adults aged 18-60 years, representative of the French population, as well as 200 male adults aged 18-40 to supplement the overall sample with a population more at risk of being potential perpatrators as reported in the scientific literature.
Who may be able to join
- Adults (any gender) between 18-80 years
- Living in France
- Fluent in French
Who cannot join
- Non-French speakers, as the questionnaire is only available in French
- Refusal to participate in the research
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Knowledge and Behavioural Intentions of French Adults (18-80 Years) Regarding Abusive Head Trauma in Infants: Description and Associated Determinants From an Online Survey
Abusive head trauma (AHT) is a leading cause of infant mortality and long-term neurodevelopmental disability, yet existing prevention programmes have shown limited effectiveness in reducing its incidence. This may reflect insufficient understanding of upstream determinants of behaviour, including population-level knowledge of AHT.
This cross-sectional online study aims to assess AHT-related knowledge, behavioural intentions, and their determinants in a sample representative of the French adult population aged 18-80 years. Participants will be recruited through a quota-based online panel and social media.
Read more
Participants will complete a standardised procedure including exposure to short videos depicting either a shaking gesture (dangerous) or non-dangerous infant-handling behaviors (playing, rocking), followed by questionnaires assessing interpretation of the gesture, knowledge of its consequences, and AHT-related knowledge. After standardised information on AHT is provided, behavioral intentions and theoretical knowledge will be reassessed.
This study will provide the first nationally representative data on AHT-related knowledge in France and inform the development of targeted, evidence-based prevention strategies.
Read the detailed description
Abusive Head Trauma (AHT) in infants is the most severe form of physical child abuse. It is defined as "an injury to the skull or intracranial contents of an infant or young child (under 5 years of age) resulting from inflicted blunt impact and/or violent shaking" (Parks, CDC). AHT is a leading cause of infant mortality, with mortality rates ranging from 7% to 26% (Niederkrotenthaler, Child Abuse Negl 2013; Hobbs, Arch Dis Child 2005; Ferguson, Crit Care Med 2017), and a major cause of long-term neurodevelopmental disability among survivors (Jayawant, Arch Dis Child 2007; Ferguson, Crit Care Med 2017). AHT predominantly affects infants younger than 2 years, with peak incidence between 2 and 4 months of age (Lee, J Dev Behav Pediatr 2007; Emrick, Child Abuse Negl 2019). Annual incidence has been estimated at 14 to 34 cases per 100,000 infants (Paget, Child Abuse Rev 2020; Rebbe, Child Abuse Rev 2020). Adult males are the most frequently identified perpetrators (Edwards, Child Abuse Rev 2020).
Over the past three decades, prevention programs have primarily focused on educating parents and caregivers about infant crying, the dangers of shaking, and strategies for stress regulation (Chang, Trauma Violence Abuse 2024; Scott, Child Abuse Negl 2022; Prokofevia, Child Abuse Negl 2026). However, several meta-analyses have reported no significant reduction in AHT incidence following such interventions (Viswanathan, JAMA 2024). These findings underscore the need to better understand upstream determinants of behavior, including knowledge, which is a key construct in many behavior change theories (Ajzen, 2005).
International studies (eg, Germany (Berthold, Pediatr Res 2019), Saudi Arabia (AlOmran, Pan Afr Med J 2022), China (Gao, Child Abuse Negl 2021), Ireland (Mann, Eur J Pediatr 2015)) report that 41% to 69% of respondents had never heard of AHT. However, these studies have several limitations. Most are single-center, involve small sample sizes, and exhibit heterogeneous methodological quality. Recruitment has typically been restricted to parents, excluding other adults who regularly care for or interact with infants. In addition, most studies assess knowledge of AHT and its consequences without providing a clear definition of AHT or explicitly evaluating recognition of the shaking behavior that can lead to AHT. Only one study has used video-based stimuli to assess recognition of shaking; however, it relied on a neutral prompt without confirmation of the nature of the depicted action, thereby limiting the validity of the knowledge assessment. Observed levels of knowledge vary widely across studies, likely reflecting both true population heterogeneity and methodological inconsistency. Data on determinants of AHT-related knowledge remain scarce. In France, in particular, no nationally representative data are available; existing studies are limited to small, single-center samples recruited in maternity settings.
This cross-sectional online survey aims to assess AHT-related knowledge, behavioral intentions, and determinants of knowledge in a sample representative of the French adult population.
Recruitment will be conducted by IPSOS BVA (organization specialized in survey and panel research) using two channels: (1) a quota-based online panel, representative of the French adult population, and (2) social media. This approach will yield three independent samples of adults aged 18-80 years residing in France. Sample 1 (n = 1,000; general population, representative) will be recruited via the online panel and supplemented with a targeted oversample of 200 men aged 18-40 years, the demographic group most frequently identified as perpetrators of AHT, recruited through social media. Sample 2 (n = 1,000; general population, representative) and Sample 3 (n = 1,000; general population, representative) will both be recruited via the online panel.
All participants will complete the same sequential procedure. First, participants will complete an 8-item sociodemographic questionnaire. Each sample will then be exposed to one short video stimulus (6-8 seconds; motion design): Sample 1 will view Video 1 (depicting a shaking gesture, representing a situation that may cause AHT); Sample 2 will view Video 2 (depicting a knee-bouncing gesture, representing a non-dangerous play activity); and Sample 3 will view Video 3 (depicting a rocking gesture, representing a non-dangerous soothing activity). After viewing their assigned video, participants will complete a 5-item questionnaire assessing their perception of the depicted gesture, their knowledge about the potential consequences of the gesture, and their knowledge about AHT. Subsequently, all participants will then view Video 1 (shaking gesture), accompanied by explicit information indicating that the depicted behaviour may cause AHT, along with a standardised operational definition of AHT. Participants will then complete a 4-item questionnaire assessing behavioral intentions and theoretical knowledge related to AHT.
AHT-related knowledge will be assessed by combining questionnaire responses into predefined categories: "perfect responder", graded levels of "intermediate responders", "incorrect responder", and "incoherent responder". Classification rules will be established a priori by a panel of experts in AHT. Descriptive analyses will be conducted to characterise the study population and to describe levels of AHT-related knowledge and behavioral intentions. Associations between participant characteristics (potential determinants) and AHT-related knowledge will be examined using appropriate statistical methods.
This study will provide the first nationally representative data on AHT-related knowledge among adults in France and will inform the development of targeted, evidence-based AHT prevention strategies.
- Conditions
- Abusive Head Trauma
- Keywords
- Abusive Head Trauma, Knowledge, Intentions, Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 1200 participants (1000 recruited through an online panel, oversample of 200 male adults aged 18-40 years recruited through social media) first exposed to Video 1 (depicting a shaking gesture in motion design, potentially causing AHT). | |
| Group 2 | 1000 participants (recruited through an online panel) first exposed to Video 2 (depicting a bouncing on knees gesture in motion design, not a dangerous playing situation). | |
| Group 3 | 1000 participants (recruited through an online panel) first exposed to Video 3 (depicting a rocking gesture in motion design, not a dangerous situation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of correct answers
Proportion of participants providing correct answers to AHT-related knowledge questions (AHT-related knowledge).
AHT-related knowledge will be assessed using a categorical variable classifying participants as "perfect," "intermediate" (with sub-levels), "incorrect," or "incoherent" responders, based on their answers to knowledge questions administered after viewing the assigned video (video 1, 2, or 3) and prior to disclosure of the definition of AHT. The response combinations used to construct this categorical variable will be determined by consensus among a panel of AHT experts.
Measured: At baseline
Secondary outcomes (2)
Proportion of risk gesture
Proportion of participants reporting ever having experienced an urge to perform a gesture at risk of causing AHT and the coping strategies employed to resist acting on such urges (AHT-related intentions).
AHT-related intentions and coping strategies will be assessed through two questions administered after disclosure of the definition of AHT: (1) a question assessing whether the participant has ever experienced an urge to perform a gesture at risk of causing AHT (eg, shaking an infant); and (2) among those responding affirmatively, an open-ended or multiple-choice question assessing the coping strategies employed to resist acting on such urges.
Measured: at baseline
Determinants, among sociodemographic variables, of AHT-related knowledge in the French adult population
The following sociodemographic variables will be collected and explored as potential determinants of AHT-related knowledge: age (continuous), sex (categorical), parity (categorical), educational level (categorical), socioeconomic position (categorical), and subjective experience of poverty (categorical). Associations between these variables and AHT-related knowledge will be examined using appropriate statistical methods for categorical and continuous determinants.
Measured: at baselin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abusive Head TraumaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- IPSOS BVA
- Responsible party
- Sponsor
- Investigators
- Enora Le ROUX, PhD, Principal investigator, Paris-Saclay West Clinical Research Unit, Sainte-Pérrine Hospital, APHPMartin CHALUMEAU, MD, PhD, Study director, Department of General Pediatrics and Infectious Diseases, Necker Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735780
- Sponsor's protocol ID
- APHP260554
- Acronym
- VEAVE IV
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Behavioural Intentions of French Adults (18-80 Years) Regarding Abusive Head Trauma in Infants: Description and Associated Determinants From an Online Survey
- ClinicalTrials.gov ID
- NCT07735780
- Acronym / sponsor ID
- VEAVE IV / APHP260554
- Conditions
- Abusive Head Trauma
- Keywords
- Abusive Head Trauma, Knowledge, Intentions, Skills
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- IPSOS BVA
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 30 Jul 2026 (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.
Abusive head trauma (AHT) is a leading cause of infant mortality and long-term neurodevelopmental disability, yet existing prevention programmes have shown limited effectiveness in reducing its incidence. This may reflect insufficient understanding of upstream determinants of behaviour, including population-level knowledge of AHT.
This cross-sectional online study aims to assess AHT-related knowledge, behavioural intentions, and their determinants in a sample representative of the French adult population aged 18-80 years. Participants will be recruited through a quota-based online panel and social media.
Participants will complete a standardised procedure including exposure to short videos depicting either a shaking gesture (dangerous) or non-dangerous infant-handling behaviors (playing, rocking), followed by questionnaires assessing interpretation of the gesture, knowledge of its consequences, and AHT-related knowledge. After standardised information on AHT is provided, behavioral intentions and theoretical knowledge will be reassessed.
This study will provide the first nationally representative data on AHT-related knowledge in France and inform the development of targeted, evidence-based prevention strategies.
Detailed description
Abusive Head Trauma (AHT) in infants is the most severe form of physical child abuse. It is defined as "an injury to the skull or intracranial contents of an infant or young child (under 5 years of age) resulting from inflicted blunt impact and/or violent shaking" (Parks, CDC). AHT is a leading cause of infant mortality, with mortality rates ranging from 7% to 26% (Niederkrotenthaler, Child Abuse Negl 2013; Hobbs, Arch Dis Child 2005; Ferguson, Crit Care Med 2017), and a major cause of long-term neurodevelopmental disability among survivors (Jayawant, Arch Dis Child 2007; Ferguson, Crit Care Med 2017). AHT predominantly affects infants younger than 2 years, with peak incidence between 2 and 4 months of age (Lee, J Dev Behav Pediatr 2007; Emrick, Child Abuse Negl 2019). Annual incidence has been estimated at 14 to 34 cases per 100,000 infants (Paget, Child Abuse Rev 2020; Rebbe, Child Abuse Rev 2020). Adult males are the most frequently identified perpetrators (Edwards, Child Abuse Rev 2020).
Over the past three decades, prevention programs have primarily focused on educating parents and caregivers about infant crying, the dangers of shaking, and strategies for stress regulation (Chang, Trauma Violence Abuse 2024; Scott, Child Abuse Negl 2022; Prokofevia, Child Abuse Negl 2026). However, several meta-analyses have reported no significant reduction in AHT incidence following such interventions (Viswanathan, JAMA 2024). These findings underscore the need to better understand upstream determinants of behavior, including knowledge, which is a key construct in many behavior change theories (Ajzen, 2005).
International studies (eg, Germany (Berthold, Pediatr Res 2019), Saudi Arabia (AlOmran, Pan Afr Med J 2022), China (Gao, Child Abuse Negl 2021), Ireland (Mann, Eur J Pediatr 2015)) report that 41% to 69% of respondents had never heard of AHT. However, these studies have several limitations. Most are single-center, involve small sample sizes, and exhibit heterogeneous methodological quality. Recruitment has typically been restricted to parents, excluding other adults who regularly care for or interact with infants. In addition, most studies assess knowledge of AHT and its consequences without providing a clear definition of AHT or explicitly evaluating recognition of the shaking behavior that can lead to AHT. Only one study has used video-based stimuli to assess recognition of shaking; however, it relied on a neutral prompt without confirmation of the nature of the depicted action, thereby limiting the validity of the knowledge assessment. Observed levels of knowledge vary widely across studies, likely reflecting both true population heterogeneity and methodological inconsistency. Data on determinants of AHT-related knowledge remain scarce. In France, in particular, no nationally representative data are available; existing studies are limited to small, single-center samples recruited in maternity settings.
This cross-sectional online survey aims to assess AHT-related knowledge, behavioral intentions, and determinants of knowledge in a sample representative of the French adult population.
Recruitment will be conducted by IPSOS BVA (organization specialized in survey and panel research) using two channels: (1) a quota-based online panel, representative of the French adult population, and (2) social media. This approach will yield three independent samples of adults aged 18-80 years residing in France. Sample 1 (n = 1,000; general population, representative) will be recruited via the online panel and supplemented with a targeted oversample of 200 men aged 18-40 years, the demographic group most frequently identified as perpetrators of AHT, recruited through social media. Sample 2 (n = 1,000; general population, representative) and Sample 3 (n = 1,000; general population, representative) will both be recruited via the online panel.
All participants will complete the same sequential procedure. First, participants will complete an 8-item sociodemographic questionnaire. Each sample will then be exposed to one short video stimulus (6-8 seconds; motion design): Sample 1 will view Video 1 (depicting a shaking gesture, representing a situation that may cause AHT); Sample 2 will view Video 2 (depicting a knee-bouncing gesture, representing a non-dangerous play activity); and Sample 3 will view Video 3 (depicting a rocking gesture, representing a non-dangerous soothing activity). After viewing their assigned video, participants will complete a 5-item questionnaire assessing their perception of the depicted gesture, their knowledge about the potential consequences of the gesture, and their knowledge about AHT. Subsequently, all participants will then view Video 1 (shaking gesture), accompanied by explicit information indicating that the depicted behaviour may cause AHT, along with a standardised operational definition of AHT. Participants will then complete a 4-item questionnaire assessing behavioral intentions and theoretical knowledge related to AHT.
AHT-related knowledge will be assessed by combining questionnaire responses into predefined categories: "perfect responder", graded levels of "intermediate responders", "incorrect responder", and "incoherent responder". Classification rules will be established a priori by a panel of experts in AHT. Descriptive analyses will be conducted to characterise the study population and to describe levels of AHT-related knowledge and behavioral intentions. Associations between participant characteristics (potential determinants) and AHT-related knowledge will be examined using appropriate statistical methods.
This study will provide the first nationally representative data on AHT-related knowledge among adults in France and will inform the development of targeted, evidence-based AHT prevention strategies.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –1200 participants (1000 recruited through an online panel, oversample of 200 male adults aged 18-40 years recruited through social media) first exposed to Video 1 (depicting a shaking gesture in motion design, potentially causing AHT). |
| Group 2 | – | –1000 participants (recruited through an online panel) first exposed to Video 2 (depicting a bouncing on knees gesture in motion design, not a dangerous playing situation). |
| Group 3 | – | –1000 participants (recruited through an online panel) first exposed to Video 3 (depicting a rocking gesture in motion design, not a dangerous situation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited through a collaboration with IPSOS BVA, a survey research organization, using a pre-existing online panel designed to be representative of the French adult general population (based on quotas), as well as social media for supplementation in one subsample. Panel members have previously provided informed consent to participate in surveys on a broad range of topics, including health-related subjects. We will recruit 3000 adults aged 18-60 years, representative of the French population, as well as 200 male adults aged 18-40 to supplement the overall sample with a population more at risk of being potential perpatrators as reported in the scientific literature.
Key inclusion criteria (3 listed)
- Adults (any gender) between 18-80 years
- Living in France
- Fluent in French
Key exclusion criteria (2 listed)
- Non-French speakers, as the questionnaire is only available in French
- Refusal to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of correct answers
Time frame: At baseline
Proportion of participants providing correct answers to AHT-related knowledge questions (AHT-related knowledge). AHT-related knowledge will be assessed using a categorical variable classifying participants as "perfect," "intermediate" (with sub-levels), "incorrect," or "incoherent" responders, based on their answers to knowledge questions administered after viewing the assigned video (video 1, 2, or 3) and prior to disclosure of the definition of AHT. The response combinations used to construct this categorical variable will be determined by consensus among a panel of AHT experts.
2 secondary outcomes
Proportion of risk gesture
Time frame: at baseline
Determinants, among sociodemographic variables, of AHT-related knowledge in the French adult population
Time frame: at baselin
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 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Enora Le ROUX, PhD principal investigator
Paris-Saclay West Clinical Research Unit, Sainte-Pérrine Hospital, APHP
Martin CHALUMEAU, MD, PhD study director
Department of General Pediatrics and Infectious Diseases, Necker Hospital, APHP
Questions about this trial
What is this clinical trial studying?
An observational study of Abusive Head Trauma, run by Assistance Publique - Hôpitaux de Paris.
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 3 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Enora Le ROUX, PhD (+ 33 1 40 03 23 66, enora.leroux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of correct answers (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.