自閉症スペクトラム障害と診断された第一子を持つ妊婦に対する治療教育プログラムの評価 (AUTMER)
自閉症スペクトラム障害（ASD）と診断された第一子を持つ妊婦に対する治療教育プログラムの評価
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.
The M.E.R (Mères Ecoute Ressources) programme is a therapeutic education intervention aimed at mothers of children with ASD during a new pregnancy. This programme, which is being piloted in France and Europe, involves a number of dimensions, both educational and behavioural (strategies for stimulating the baby, use of specific communication and interaction tools) and psychological (reduction of stress, anxiety, etc. in the mother).
The programme comprises 8 one-to-one sessions lasting 1.5 hours every 15 days. The first and last of these are for assessment purposes, with the 6 intermediate sessions constituting the support. The structure of the programme and the sessions is based on what is recommended in therapeutic education. The sessions can take place on the hospital site or by teleconsultation (remote consultation used in the context of healthcare).
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Anita Beggiato, PHD
- 電話番号：0033140032000
- メール：anita.beggiato@aphp.fr
研究連絡先のバックアップ
- 名前：Richard Delorme, PHD
- 電話番号：0033140034130
- メール：richard.delorme@aphp.fr
研究場所
-
-
-
Paris、フランス、75019
- 募集
- Hôpital Robert Debré
-
コンタクト：
- Anita Beggiato, PHD
- 電話番号：01 40 03 20 00
- メール：anita.beggiato@aphp.fr
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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 if possible: the Autism Diagnostic Observation Schedule ADOS, and/or ADI
- Informed consent from mother and sec
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：control group
Pregnant women followed by the center in the period before the intervention is implemented (the start of which is determined by randomization) |
|
|
実験的：experimental group
Pregnant women followed by the center during the period after the intervention is implemented (the start of which is determined by randomization) |
The M.E.R program is a therapeutic education intervention for mothers of children with ASD during a new pregnancy. This program, which is a pilot in France and in Europe, involves several dimensions, both pedagogical and behavioral (strategies for stimulating the baby, use of specific communication and interaction tools) and psychological (reduction of stress, anxiety, etc. in the mother). It includes 8 individual interviews of 1h30 every 15 days. The first and the last one are for evaluation purposes, the 6 intermediate sessions constitute the accompaniment. The structure of the program and the sessions are based on what is recommended in therapeutic education. The sessions can take place on the hospital site or teleconsultation (remote consultation used in the context of healthcare). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Manchester Assessment of Caregiver-infant Interaction (MACI) "caregiver non-directiveness" subscore
時間枠：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. |
5 months after delivery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
時間枠：between 11 weeks and 26 weeks of gestation
|
To evaluate the effect of the MER program on maternal anxiety related to pregnancy |
between 11 weeks and 26 weeks of gestation
|
|
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
時間枠：at 3 months after intervention
|
To evaluate the effect of the MER program on maternal anxiety related to pregnancy |
at 3 months after intervention
|
|
Appraisal of Life Events Scale (ALES)
時間枠：between 11 weeks and 26 weeks of gestation
|
Perceived pregnancy-related stress in the mother.scale with a list of adjectives, rated on a five-point Likert scale) |
between 11 weeks and 26 weeks of gestation
|
|
Appraisal of Life Events Scale (ALES)
時間枠：at 3 months after intervention
|
Perceived pregnancy-related stress in the mother.scale with a list of adjectives, rated on a five-point Likert scale |
at 3 months after intervention
|
|
Edimburgh Postnatal Depression Scale (EPDS)
時間枠：10 months after birth
|
used to assess the risk of postnatal depression and is useful for identifying the presence of anxiety symptoms.The threshold retained for the French validation is 10.5, above which a depression is possible and below which the risk is very low. |
10 months after birth
|
|
quality of life score-Bref (WhoQol-Bref)
時間枠：10 months after birth
|
WHOQOL-BREF includes 26 items that measure the following broad domains: physical health, psychological health, social relationships and environment. |
10 months after birth
|
|
parental anxiety score (HAM)
時間枠：10 months after birth
|
hetero-questionnaire with 14 items, measuring both the psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) expression of anxiety. Each item is rated on a Likert scale from 0 to 4 (total range 0-56, where <17= mild anxiety; 18-24= mild to moderate; 25-30 moderate to severe) |
10 months after birth
|
|
mother's intelligence quotient
時間枠：between 11 weeks and 26 weeks of gestation
|
measured by Raven's Progressive Matrices |
between 11 weeks and 26 weeks of gestation
|
|
Social Responsiveness Scale (SRS)
時間枠：between 11 weeks and 26 weeks of gestation
|
to refine the evaluation of social difficulties in a dimensional way |
between 11 weeks and 26 weeks of gestation
|
|
Wechsler Mullen scale
時間枠：between 11 weeks and 26 weeks of gestation
|
developmental level of the ASD child |
between 11 weeks and 26 weeks of gestation
|
協力者と研究者
捜査官
- 主任研究者：Anita Beggiato, PHD、APHP
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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