NCT07735780

Brief 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. 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.

Trial Health

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Trial Health Score

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Enrollment
3,200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

29 days

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

Abusive Head TraumaKnowledgeIntentionsSkills

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline

Secondary Outcomes (2)

  • Proportion of risk gesture

    at baseline

  • Determinants, among sociodemographic variables, of AHT-related knowledge in the French adult population

    at baselin

Study Arms (3)

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Adults (any gender) between 18-80 years
  • Living in France
  • Fluent in French

You may not qualify if:

  • Non-French speakers, as the questionnaire is only available in French
  • Refusal to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Enora Le ROUX, PhD

    Paris-Saclay West Clinical Research Unit, Sainte-Pérrine Hospital, APHP

    PRINCIPAL INVESTIGATOR
  • Martin CHALUMEAU, MD, PhD

    Department of General Pediatrics and Infectious Diseases, Necker Hospital, APHP

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 30, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07