Effect of Infant Sign Training on Speech-language Development
ConditionCleft Palate Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-24
SponsorUniversity Hospital, Ghent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Born with cleft palate (with or without cleft lip)
Having Dutch as mother tongue
Disqualifiers
syndromic cleft
more than mild hearing loss (i.e. > 40dB hearing threshold bilaterally)
neurosensory hearing loss
cognitive delay
Trial design
Design model
Parallel
Treatments tested in this trial
Infant sign training
BehavioralTraining session 1: Information is given about what infant signs are, how they originated, how speech and (gestural) language develop in young children with CP ± L, the possible advantages of using infant signs and tips for success. Twelve signs are chosen to start with: six narrative signs (mostly object concepts) and six steering signs (mostly non-object concepts). Training session 2: Experiences with using infant signs at home are shared, repetition of the 12 infant signs and tips for success are discussed. Another 12 signs are chosen to add to the repertoire the caregivers can use, based on caregiver input. Training session 3: The same as training session 2. The content is based on the input the caregivers experience. Another 12 signs are chosen to add to the repertoire the caregivers can use, based on caregiver input. Reading aloud while using infant signs is shown and practiced.
Verbal training
BehavioralTraining session 1: Information is given about how speech and language develop in young children with CP ± L and how caregivers can support their child during this development Tips for success and suggestions on how to use these supportive verbal techniques at home are discussed. Training session 2: Experiences with using supportive verbal techniques at home are shared and supportive verbal techniques repeated. Information is provided about how children learn new words and tips for success are expanded. Training session 3: The same as training session 2. The content is based on the input the caregivers experience. Additionally, advances of reading aloud are discussed and reading aloud is practiced.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Symbolic Gesture Training GroupExperimental treatment 1 intervention
Group B: Verbal Training GroupActive comparator 1 intervention
Group C: No Intervention Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Receptive language level based on language test
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.
Time frame
12 months2
Expressive language level based on language test
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.
Time frame
12 months3
Total language level based on caregiver report
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.
Time frame
12 monthsSecondary outcomes
1
Communicative acts produced by the child
The communicative acts of the child will be analyzed based on a video recording of 30 minutes free play with four standardized toy sets (i.e., a farm, a house, cutlery, and vehicles) between the child and caregiver at T0, T1 and T2. Each potential communicative act of the child will be annotated by the means of communication (eye contact, gesture or vocalization; vocalization will be identified as non-canonical, canonical or word). This outcome measure will be expressed in the total number of communicative acts produced by the child.
Time frame
12 months2
Communicative acts produced by the caregiver
The communicative acts of the caregiver will be analyzed based on a video recording of 30 minutes free play with four standardized toy sets (i.e., a farm, a house, cutlery, and vehicles) between the child and caregiver at T0, T1 and T2. Each potential communicative act of the caregiver will be annotated by the means of communication (eye contact, gesture or vocalization). This outcome measure will be expressed in the total number of communicative acts produced by the caregiver.
Time frame
12 months3
Articulatory precision of the child
Based on the vocalizations of the child, the Percentage Consonants Correct will be determined. This outcome measure is expressed in percentage.
Time frame
12 mothsSponsors and contacts
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University Hospital, Ghent
Lead sponsor
University Ghent
Collaborator
Source ClinicalTrials.gov