Evaluating the Effect of Combined Parent Training Plus Speech Therapy on Children With Speech Development Disorder.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Language Development Level Test (TVL)
研究概览
简要总结
Language is an extremely complex cognitive function that, in situations of typical development, i.e. in the absence of deficits or environmental risk, is generally acquired with apparent ease and naturalness (Kuhl, 2010).
The first 1,000 days of life are considered a key time window in which children's developmental trajectories and future outcomes are shaped. During this period, it is crucial to provide children with nurturing experiences such as responsive care and appropriate learning opportunities (Britto et al., 2017).
Most children learn communication skills (e.g., pointing, gesturing) and language skills (e.g., saying words, following instructions) from high-quality interactions with parents and caregivers. However, some children may have language learning difficulties for a variety of reasons, including genetic, neurological and environmental.
Not all children necessarily follow the stages outlined: some present delayed language development. The early identification and diagnosis of the language disorder is therefore very important as this deficit can have a negative impact on the child's subsequent development of skills, the way he/she relates and subsequent acquisition skills in primary school.
This research aims to assess whether parents, guided and monitored by the speech therapist and psychologist through parental training, can try out specific and effective strategies that enable them to become a facilitating model for the child's communicative-linguistic learning, thereby also improving their quality of life.
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)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of 'Developmental Language Disorders' (DLD)
- •Age between 3 and 5 years.
- •Signature of informed consent by parents and/or legal guardians.
排除标准
- •No sensory impairment or another medical or neurological condition (ADHD, Autism, Deafness, Mental Retardation <70);
- •Significant medical conditions that could interfere with participation in the study.
- •Failure to sign informed consent by parents and/or legal guardians.
研究组 & 干预措施
Assisted speech therapy intervention + parent training
The treatment group consists of 20 children diagnosed with DLD (Language Development Disorder).
The participants were randomly assigned and will undergo a structured rehabilitation programme of parent training + speech therapy
干预措施: Assisted speech therapy intervention + parent training (Behavioral)
Standard Speech Therapy
The control group consisted of 20 children diagnosed with DLD (Language Development Disorder).
Participants were randomly assigned and were subjected to standard therapy approaches, which included traditional speech therapy provided by qualified therapists.
干预措施: standard speech therapy (Behavioral)
结局指标
主要结局
Language Development Level Test (TVL)
时间窗: T0 (baseline)- T1 (6months)
The Test of Verbalization and Language Development is a standardized tool designed to assess various aspects of language development, including verbal production, comprehension, sentence construction, phonological accuracy, and morphosyntactic abilities. The weighted score ranges from 0 to 10, with higher scores indicating better language development.
WHOQOL
时间窗: T0(baseline)-T1(6 months)
It assesses individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, norms and standards. The WHOQOL-BRIEF is a 26-item self-report instrument that assesses four domains that are assumed to represent the Quality of Life (QOL) construct: the physical domain, the psychological domain, the social relations domain and the environmental domain, plus two aspects for assessing overall QOL and general health. It provides a multi-dimensional profile of QOL domain and sub-domain scores
The Child Behavior Checklist (CBCL)
时间窗: T0(baseline)-T1(6months)
The Child Behavior Checklist (CBCL) is a caregiver-reported questionnaire used to identify emotional and behavioral problems in children. It measures multiple domains, including emotional reactivity, anxiety, attention problems, and social difficulties. The T-scores do not have a specific range, but values between 50 and 70 are considered within the normal range, while 70 to 100 indicates clinical significance. Higher scores indicate greater behavioral problems.
Questionnaire on Parenting Styles (QSP)
时间窗: T0(baseline)-T1(6 months)
This instrument consists of different forms that consider the three fundamental domains of parent-child interaction: a) the social domain: assessed through 8 items; b) the educational domain: assessed through 7 items; c) the disciplinary domain: assessed through 2 items. In this study, each parent completed four forms of the questionnaire: one assessing what their parental behaviour is like in reality (real style; Form A), one assessing what they would ideally like their own behaviour to be like (ideal style; Form B), one assessing what their partner's parental behaviour is like in reality (real style; Form C) and one assessing what they would ideally like their partner's parental behaviour to be like (ideal style; Form D).
Il Parenting Stress Index
时间窗: T0(baseline)-T1(6 months)
It defines the level of stress (anxiety, discomfort, maladaptive coping, etc.) that a parent is experiencing in their parental role. It is closely linked to personal characteristics of the subject that reverberate in the way he or she performs and experiences this role. The stress components most associated with this subscale are: a negative experience regarding one's parental competence; stress resulting from the restrictions the parental role places on other social roles important to the subject; conflict with the spouse; lack of social support; and the presence of depression in the clinical sense.
次要结局
未报告次要终点