Evaluating the Effect of Combined Parent Training Plus Speech Therapy on Children With Speech Development Disorder.

Overview

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.

Interventions

• Behavioral Assisted speech therapy intervention + parent training
  The intervention was tailored to individual needs and aimed at improving verbal expression, communicative initiative, and social engagement. Each child receives therapy for a period of 16 weeks, for a total of 32 sessions, twice a week, with each session lasting 45 minutes and in addition 16 sessions of parent traning once a week for 45 minutes.Intervention sessions included tasks designed to engage the child in verbal and social interactions, (such as naming objects, answering questions and per
• Behavioral standard speech therapy
  Therapy followed established protocols and was adapted to meet the specific needs of the children. Each child received therapy for a period of 16 weeks (twice a week), for a total of 32 sessions.• Standard therapeutic approaches included exercises to improve verbal communication and social engagement, such as object naming, sentence construction and comprehension tasks. Therapists adapted the intervention to the individual communication goals of each 45-minute session.

Primary outcome measures

• Language Development Level Test (TVL) [Time frame: T0 (baseline)- T1 (6months)]
• The Child Behavior Checklist (CBCL) [Time frame: T0(baseline)-T1(6months)]
• Questionnaire on Parenting Styles (QSP) [Time frame: T0(baseline)-T1(6 months)]
• WHOQOL [Time frame: T0(baseline)-T1(6 months)]
• Il Parenting Stress Index [Time frame: T0(baseline)-T1(6 months)]

Eligibility criteria

Inclusion criteria

• Diagnosis of 'Developmental Language Disorders' (DLD)
• Age between 3 and 5 years.
• Signature of informed consent by parents and/or legal guardians.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• IRCCS Neurolesi Bonino Pulejo, Messina,, Messina, Messina 98124 — Messina

Publications

• Zwitserlood-Nijenhuis MA, Wiefferink CH, Gerrits E. A randomized study of parent- versus child-directed intervention for Dutch toddlers with DLD. Int J Lang Commun Disord. 2023 Sep-Oct;58(5):1768-1782. doi: 10.1111/1460-6984.12901. Epub 2023 May 29. PMID 37248804
• Hawa VV, Spanoudis G. Toddlers with delayed expressive language: an overview of the characteristics, risk factors and language outcomes. Res Dev Disabil. 2014 Feb;35(2):400-7. doi: 10.1016/j.ridd.2013.10.027. Epub 2013 Dec 14. PMID 24334229
• Collisson BA, Graham SA, Preston JL, Rose MS, McDonald S, Tough S. Risk and Protective Factors for Late Talking: An Epidemiologic Investigation. J Pediatr. 2016 May;172:168-174.e1. doi: 10.1016/j.jpeds.2016.02.020. Epub 2016 Mar 8. PMID 26968834
• Rowe ML. A longitudinal investigation of the role of quantity and quality of child-directed speech in vocabulary development. Child Dev. 2012 Sep-Oct;83(5):1762-74. doi: 10.1111/j.1467-8624.2012.01805.x. Epub 2012 Jun 20. PMID 22716950
• Buschmann A, Jooss B, Rupp A, Dockter S, Blaschtikowitz H, Heggen I, Pietz J. Children with developmental language delay at 24 months of age: results of a diagnostic work-up. Dev Med Child Neurol. 2008 Mar;50(3):223-9. doi: 10.1111/j.1469-8749.2008.02034.x. Epub 2008 Feb 11. PMID 18266869
• Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;38 PMID 27717615

Identifiers

NCT: NCT07426276 · DLD25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗