The Effect of Using Symbolic Gestures on the Speech and Language Development in Prelinguistic Children Born With Cleft Palate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Ghent
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Expressive language level based on language test
Study Overview
Brief Summary
Children born with a cleft lip and palate (CLP) are known to be at risk for speech-language disorders that impact academic and social emotional growth. Even at very young ages (<3 years), speech-language disorders are already observed. It is hypothesized that speech-language intervention delivered before the age of 3 years old could decrease the impact of CLP on speech-language development. This would result in a decreased need for speech-language therapy on the long-term and a reduced burden of care on children, families and health services. However, no evidence is yet available to support any specific model of early speech-language intervention in this population. Consequently, no standardized clinical practice guidelines are available yet. Symbolic gesture training in combination with verbal input expands the natural communication of young children including multimodal speech-language input (i.e., verbal and manual input) via caregivers who act as co-therapists. To contribute to the evidence-based practice in the field of cleft speech therapy, this research project aims to determine the effectiveness and feasibility of symbolic gesture training in one-year old children with CLP by comparing different intervention approaches based on perceptual, psychosocial and qualitative outcome measures.
Detailed Description
Children with CP±L are known to be at risk for speech-language delays that impact educational and social-emotional growth. Early intervention in this population mostly focuses on improving verbal input via caregivers or professionals without including a multimodal language input. As stated above, no evidence is yet available for the effectiveness and feasibility of early intervention based on symbolic gesture training in combination with verbal input to improve speech-language skills in young children with CP±L. To contribute to the evidence-based practice in the field of early cleft palate speech intervention, this research project will focus on the effectiveness of symbolic gesture training in one-year old children with CP±L by comparing different intervention approaches based on quantitative and qualitative outcome measures. This project meets the need to evaluate the impact of early intervention on speech-language outcomes in children with CP±L as proposed by several researchers based on reviews regarding this topic.
The primary objective is to explore if children with CP±L who are enrolled in symbolic gesture training to support verbal in- and output at the age of 12 months have increased receptive and expressive language skills compared to children with CP±L who are enrolled in verbal training or not involved in any intervention at all.
The secondary objectives are:
2.1 To explore if children with CP±L who are enrolled in symbolic gesture training at the age of 12 months have improved speech skills, compared to children with CP±L who are enrolled in verbal training or not involved in any intervention at all; 2.2 To explore if children with CP±L who are enrolled in symbolic gesture training at the age of 12 months demonstrate more gesture use, compared to children with CP±L who are enrolled in verbal training or not involved in any intervention at all; 2.3 To explore if caregivers of children with CP±L who are enrolled in symbolic gesture training when their child is 12 months of age provide more frequent and more complex linguistic input to their child's utterances compared to caregivers of children with CP±L who are enrolled in verbal training or not involved in any intervention at all.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
All tests and recordings will be performed by two SLPs of the research group with experience in the diagnosis and treatment of speech and language disorders in children with CP±L. The annotation, analysis and scoring will be performed by the same SLPs. Both raters will analyze 100% of the video-recordings to calculate inter-rater reliability. To calculate intra-rater reliability, both raters will re-assess 20% of the recordings. The raters will not provide intervention to any of the included children and caregivers. They will be blinded for group allocation of the child and caregivers.
Eligibility Criteria
- Ages
- 12 Months to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Born with cleft palate (with or without cleft lip)
- •Having Dutch as mother tongue
Exclusion Criteria
- •syndromic cleft
- •more than mild hearing loss (i.e. > 40dB hearing threshold bilaterally)
- •neurosensory hearing loss
- •cognitive delay
- •motor delay
Arms & Interventions
Symbolic Gesture Training Group
Caregivers of children who are assigned to the SGT group will participate in three caregiver training meetings to learn how to use infant signing in combination with verbal training to promote the speech and language development of their child. These meetings will take place 1 month (meeting 1), 2 months (meeting 2) and 3 months (meeting 3) after baseline assessments are performed (T0). Each meeting will take two hours. After the first training session (meeting 1), caregivers will start using the symbolic gestures to support verbal in- and output at home with their child.
Intervention: Infant sign training (Behavioral)
Verbal Training Group
Caregivers of children who are assigned to the VT group will participate in three caregiver training meetings to learn how to use verbal training to promote the speech and language development of their child. These meetings will take place 1 month (meeting 1), 2 months (meeting 2) and 3 months (meeting 3) after baseline assessments are performed (T0). Each meeting will take two hours. After the first training session (meeting 1), caregivers will start using supporting verbal in- and output at home with their child.
Intervention: Verbal training (Behavioral)
No Intervention Control Group
Standard clinical care at this moment at the Cleft Palate Teams of the University Hospitals of Ghent and Leuven includes providing information to caregivers about speech-language development and encouraging caregivers to communicate with their children. This information will be orally provided by an SLP during a standard clinical appointment at the cleft team at the age of 12 months. A brochure including this information will be provided. Caregivers of children who will be assigned to group C will have the opportunity to receive the most effective intervention (SGT or VT) after finishing the study.
Outcomes
Primary Outcomes
Expressive language level based on language test
Time Frame: 12 months
To verify the expressive language level, the Dutch Nonspeech Test will be used at T0 and T1. This standardized test observes, scores and judges communication conditions and first verbal and non-verbal communication in the age range of 12 to 21 months. At T2, the Schlichting Test of Language Comprehension and Language Production will be used. This standardized test measures receptive and expressive language development starting from 24 months of age. This outcome measure will be expressed in percentiles.
Receptive language level based on language test
Time Frame: 12 months
To verify the receptive language level, the Dutch Nonspeech Test will be used at T0 and T1. This standardized test observes, scores and judges communication conditions and first verbal and non-verbal communication in the age range of 12 to 21 months. At T2, the Schlichting Test of Language Comprehension and Language Production will be used. This standardized test measures receptive and expressive language development starting from 24 months of age. This outcome measure will be expressed in percentiles.
Total language level based on caregiver report
Time Frame: 12 months
Caregivers will complete the Dutch version of the MacArthur Communicative Development Inventory, 'words and signs' (T0 and T1) or 'words and sentences' (T2). These standardized questionnaires evaluate word comprehension and production, the use of signs by the child, and grammatical development. This outcome measure will be expressed in percentiles.
Secondary Outcomes
- Communicative acts produced by the caregiver(12 months)
- Articulatory precision of the child(12 moths)
- Communicative acts produced by the child(12 months)