Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 2
研究概览
简要总结
This study entails a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs). The objectives of the current study are to examine whether the PIE intervention (a) transforms parent-infant transactions over time as intended, thereby facilitating increases in the time infants spend in joint engagement with their parents, and (b) is associated with improved social-communication functioning and positive changes in indices of autonomic self-regulation in infants at-risk for NDs.
详细描述
Rationale:
Providing intervention during infancy, before the full emergence of the symptoms that would lead to a diagnosis of ND based on a behavioral phenotype (e.g., autism spectrum disorder (ASD), language disorder, or attention-deficit/hyperactivity disorder) is supported by 4 premises: (1) The first two years of life are an especially active period of neural development. Due to rapid synaptic proliferation and experientially-influenced shaping of functional connectivity, interventions initiated in infancy may be powerful in promoting more typical neural connectivity (2) Biologically-based differences in infants at-risk for NDs lead to observable differences in sensory reactivity and communication behaviors in most infants by 9-15 months, prior to the full emergence of diagnostic symptoms. (3) Differences in infant behaviors influence the quantity and quality of parent responses. (4) Parent-child transactional processes begin early in infancy and impact long-term child outcomes. Based on these premises, the investigators propose a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for NDs. PIE is designed to directly impact parent responses to behaviors commonly observed in infants at-risk for NDs. Without intervention, these behaviors may fail to elicit parent responses that efficiently scaffold child communication development. Extensive research shows positive associations between caregiver responsiveness and child communication outcomes. Responsiveness is defined by multiple dimensions (i.e., sensitivity, contingency, encouragement, matching interests/activity level, physical affection, quality of language input [e.g., verbal scaffolding], reciprocity, and shared control), which vary within and across caregivers. Children play an active role in eliciting responses from caregivers, emphasizing the co-regulatory or transactional nature of these interactions. This includes biobehavioral co-regulation of arousal levels. Whereas much research comes from studies of typical development, similar transactions occur with young children with NDs. Parent responses vary depending on the preceding behaviors of the child. For example, parents are more likely to respond, and to give a verbal response, to their one-year-olds' gestures than nongestural communicative bids (vocalizations, gaze, actions); also, adults are more likely to respond to infants' speech-like than nonspeech-like vocalizations. Parent responsiveness, in turn, predicts communication outcomes of children with varied NDs.
Aims:
Specific Aim 1: Evaluate the differential changes in attuned parent responsiveness following coaching on two PIE domains - responses to variable infant (a) sensory reactivity (SR) or (b) prelinguistic communication (PC) - as well as cumulative changes in attuned parent responses following coaching on both PIE domains.
Specific Aim 2: Estimate the separate and combined effects of PIE intervention domains on parent-infant engagement and infant-initiated communication with parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors at all time points after randomization will be blind to the child's treatment arm allocation. Since parents are being coached as part of the intervention, it is not possible to keep them blind to their treatment arm.
入排标准
- 年龄范围
- 11 Months 至 16 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the intervention trial: infant must meet risk criteria on the First Years Inventory (Calculated based on data collected in another study where risk status on the FYI was confirmed with follow up at 3 years. We empirically determined combinations of the two FYI domain scores that would sort respondents into "at-risk" and "not-at-risk." The resulting cut-points enabled us to sort children such that we capture about 1/3 of those who would go on to be confirmed as having a autism spectrum diagnosis while misclassifying less than 5% of the typically developing (TD) sample as at-risk). Infants also must score at least one s.d. below the mean on either the Receptive or Expressive subscale t scores AND meet the following SPA inclusion criteria on hyporeactivity (HYPO) or hyperreactivity (HYPER):
- •"HYPO": Cut-point (equal or greater than) of 1.69 for Mean of the raw orienting score across 7 items, each with the range of 1 to 4 possible points)
- •"HYPER": Cut-point (equal or greater than) of .333 for Mean of the raw approach/avoid novel toys score across 9 items, each with the range of 0 to 2 possible points) OR Any clear "defensive" response on orienting items or "Yes" to covering ears to sound (in stereotypies checklist)
排除标准
- •families who speak English < 50% of the time at home
- •infants with previously identified genetic disorders (e.g., Down syndrome)
- •infants with identified vision/hearing/physical impairments.
结局指标
主要结局
Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 2
时间窗: Baseline, Posttest 2 (13-16 weeks after baseline)
This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in dyadic engagement (higher level supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 1
时间窗: Baseline, Posttest 1 (6-8 weeks after baseline)
This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in dyadic engagement (higher level supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
次要结局
- Change in Mullen Scales of Early Learning Receptive Language T-Scores From Baseline to Posttest 2(Baseline, Posttest 2 (13-16 weeks after baseline))
- Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 1 in Hypo-reactivity(Baseline, posttest 1 (6-8 weeks after baseline))
- Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 1(Baseline, Posttest 1 (6-8 weeks after baseline))
- Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 2(Baseline, Posttest 2 (13-16 weeks after baseline))
- Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 1(Baseline, Posttest 1 (6-8 weeks after pretest))
- Change in Skin Conductance Levels From Baseline to Posttest 2(Baseline, Posttest 2 (13-16 weeks after baseline))
- Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 2(Baseline, posttest 2 (13-16 weeks after baseline))
- Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 1(Baseline, Posttest 1 (6-8 weeks after pretest))
- Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 2(Baseline, Posttest 2 (13-16 weeks after pretest))
- Change in Respiratory Sinus Arrhythmia From Baseline to Posttest 2 During Social Stimuli(Baseline, Posttest 2 (13-16 weeks after baseline))
- Change in Respiratory Sinus Arrhythmia From Baseline to Posttest 2 During Non-Social Stimuli(Baseline, Posttest 2 (13-16 weeks after baseline))
- Change in Sensory Processing Assessment for Young Children From Baseline to Posttest 2 in Hypo-Reactivity(Baseline, posttest 2 (13-16 weeks after baseline))
- Change in The Attention Following Protocol (AF Protocol) From Baseline to Posttest 2(Baseline, Posttest 2 (13-16 weeks after baseline))
- Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 1 in Hyper-reactivity(Baseline, posttest 1 (6-8 weeks after baseline))
- Change in The Behavioral Observation of Social Communication Change (BOSCC) From Baseline to Posttest 2(Baseline, Posttest 2 (13-16 weeks after baseline))
- Change in Sensory Processing Assessment for Young Children From Baseline to Posttest 2 in Hyper-Reactivity(Baseline, posttest 2 (13-16 weeks after baseline))
- Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 2 in Hyper-reactivity(Baseline, Posttest 2 (13-16 weeks after baseline))
- Change in Mullen Scales of Early Learning Expressive Language T-scores From Baseline to Posttest 2(Baseline, posttest 2 (13-16 weeks after baseline))
- Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 2 in Hypo-reactivity(Baseline, posttest 2 (13-16 weeks after baseline))