对第一个孩子被诊断患有自闭症谱系障碍的孕妇的治疗教育计划的评估 (AUTMER)

Randomized controlled trial with deferred start, French multicenter stepped-wedge type.

The start date of the intervention in each center will be done by randomization, defining 2 periods: a control period located before the start of the intervention, and an experimental period located after the start of the intervention.

This design allows the principal investigating team to train the centers associated in turn with the intervention, and to have a control group with structured follow-up but without intervention.

All subjects will be included before 26 ADT and assigned to the control or experimental group, depending on the time of inclusion and the randomization of the center to which they belong.

The follow-up will be conducted in 2 phases: 1. during pregnancy and 2. After the birth of the child.

Subjects included were pregnant women who already had a child with an ASD diagnosis, the second parent if present, and the newborn at risk for an ASD diagnosis.

The primary objective of this study is to evaluate the effect of an innovative therapeutic education program (the MER program) versus control in pregnant women with a first child followed for ASD on the quality of interaction strategies of the mother-infant dyad at 10 months postpartum.

The primary endpoint was the caregiver non-directiveness subscore of the Manchester Assessment of Caregiver-infant Interaction (MACI) scale at 10 months postpartum. This subscore is both the most sensitive to intervention and predictive of ASD diagnosis.

The first secondary objective is the evaluation of the effect of the MER versus control program on:

• maternal pregnancy-related anxiety (PRAQ-R2 score) ;
• Anxious and depressive symptomatology and quality of life (WhoQoL-Bref score) in the mother and the second parent during pregnancy (EPDS score) and up to 20 months of age of the newborn (HAM-Anxiety and HAM-Depression scores);
• perceived stress related to pregnancy (ALES score)
• mother-infant interaction at 10 and 20 months (MACI score and subscore);
• autistic signs in at-risk infants at 20 months (ADOS Toddler score);

The second secondary objective was to study variables that could impact the effect of the intervention, including

• adherence: compliance with sessions, satisfaction of participants (PEI-Parent score) ;
• other variables that could modulate the effect of the intervention: sociodemographic variables (socioeconomic level, family configuration, number of children); clinical profile of the mother (intellectual efficiency (Raven's PM score), psychiatric comorbidities (DIGS, SRS score)); clinical profile of the child already diagnosed (ADI-R and ADOS score; developmental level); clinical profile of the infant at risk (gestational age, MSEL, IBQ-R and ECBQ scores).

The third secondary objective was to describe the barriers and levers to the implementation of the intervention.

Characteristics related to the implementation of the intervention (recruitment, uptake, fidelity, and implementation) will be collected, as well as the profile of mothers who did not participate in the project.