Evaluation of a Therapeutic Education Program for Pregnant Women With a First Child Diagnosed With an Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Manchester Assessment of Caregiver-infant Interaction (MACI) "caregiver non-directiveness" subscore
研究概览
简要总结
Autism Spectrum Disorder (ASD) is a heterogeneous set of severe developmental abnormalities of the nervous system characterized by deficits affecting social interactions and verbal and non-verbal communication, as well as the presence of restricted interests, repetitive behaviors, and atypical sensory manifestations . ASD affects approximately 1% of the general population (Elsabbagh et al., 2012). Studies of siblings of individuals with ASD show that ASD is present in 7-20% of the offspring in families where a child has had a diagnosis of ASD and this prevalence increases if there are two diagnosed children.
Several studies show the benefits of interventions targeting parents' interaction strategies in the early phases of development of infants at high risk for ASDs, in reducing the risk itself or its severity. Very early intervention, due to the presence of significant brain plasticity at these stages, may be particularly effective in changing these emerging trajectories, from a "preventive intervention" perspective that would aim to mitigate developmental risk and alter prodromal symptom trajectories, rather than eliminate a condition.
Our hypothesis is that the implementation of a specific therapeutic education program during a new pregnancy in the mother of a child with a diagnosis of ASD (MER Program) could improve the mother's well-being, increase parenting communication skills, and thereby improve interaction with the newborn at high risk for ASD. If the infant is affected, it may also reduce the symptoms of the disorder. Indirectly, it could also improve the well-being of the other parent involved in the interaction.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
To ensure blinding, the primary endpoint, assessed on video, will be measured at the end of the study by a blinded investigator from the randomization group and from a different center than the inclusion center.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mothers of children with a diagnosis of ASD, in pregnancy (before the 26th week of amenorrhea);
- •The diagnosis of ASD of the older child has been made, according to the DSM IV-TR or DSM 5 criteria, formalized by a diagnostic evaluation including: the Autism Diagnostic Observation Schedule ADOS, the Autism Diagnostic Interview - Revised version (ADI-R) accompanied by a cognitive evaluation of the child (Wechsler/Mullen Scales of Early Learning/Raven's Progressive Matrices);
- •Informed consent from mother and sec
排除标准
- •Presence of a clearly identified and unstabilized severe psychiatric disorder in the mother (confirmed by medical interview and DIGS questionnaire conducted at the time of the inclusion visit) and/or intellectual disability;
- •Engagement in another form of individual therapeutic intervention.
- •Refusal of either parent (for child assessment, primary criterion)
- •Parents not proficient in French language
- •Persons (mother or second parent) under legal protection, guardianship or trusteeship, persons deprived of liberty, under court protection, under psychiatric care, under constraint, admitted to a health or social institution for purposes other than research
- •Persons with cognitive disorders or intellectual disabilities
研究组 & 干预措施
control group
Pregnant women followed by the center in the period before the intervention is implemented (the start of which is determined by randomization)
experimental group
Pregnant women followed by the center during the period after the intervention is implemented (the start of which is determined by randomization)
干预措施: The M.E.R. program (Other)
结局指标
主要结局
Manchester Assessment of Caregiver-infant Interaction (MACI) "caregiver non-directiveness" subscore
时间窗: 5 months after delivery
mother-baby interaction in the experimental group versus the control group at 5 months postpartum. This subscore is the most sensitive to intervention and predictive of ASD diagnosis.
次要结局
- mother's intelligence quotient(between 11 weeks and 26 weeks of gestation)
- Edimburgh Postnatal Depression Scale (EPDS)(10 months after birth)
- parental anxiety score (HAM)(10 months after birth)
- Appraisal of Life Events Scale (ALES)(at 3 months after intervention)
- quality of life score-Bref (WhoQol-Bref)(10 months after birth)
- Wechsler Mullen scale(between 11 weeks and 26 weeks of gestation)
- Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore(at 3 months after intervention)
- Social Responsiveness Scale (SRS)(between 11 weeks and 26 weeks of gestation)