Effect of Infant Sign Training on Speech-language Development

NCT06143254 | Recruiting

• 1 other identifier: ONZ-2022-0581
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Palate Children

Keywords

cleft palate; gesture; speech and language development; therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (3)

• Communicative acts produced by the child

  12 months

• Communicative acts produced by the caregiver

  12 months

• Articulatory precision of the child

  12 moths

Study Arms (3)

Symbolic Gesture Training Group

EXPERIMENTAL

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.

Behavioral: Infant sign training

Verbal Training Group

ACTIVE COMPARATOR

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.

Behavioral: Verbal training

No Intervention Control Group

NO INTERVENTION

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.

Interventions

Infant sign training BEHAVIORAL

Training 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.

Symbolic Gesture Training Group

Verbal training BEHAVIORAL

Training 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.

Verbal Training Group

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born with cleft palate (with or without cleft lip)
• Having Dutch as mother tongue

You may not qualify if:

• syndromic cleft
• more than mild hearing loss (i.e. \> 40dB hearing threshold bilaterally)
• neurosensory hearing loss
• cognitive delay
• motor delay

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

RECRUITING

Related Publications (7)

• De Ryck M, Van Lierde K, Alighieri C, Hens G, Bettens K. A protocol for a randomized-controlled trial to investigate the effect of infant sign training on the speech-language development in young children born with cleft palate. Int J Lang Commun Disord. 2023 Nov-Dec;58(6):2212-2221. doi: 10.1111/1460-6984.12920. Epub 2023 Jun 28.

  PMID: 37376898 BACKGROUND

• Lancaster HS, Lien KM, Chow JC, Frey JR, Scherer NJ, Kaiser AP. Early Speech and Language Development in Children With Nonsyndromic Cleft Lip and/or Palate: A Meta-Analysis. J Speech Lang Hear Res. 2019 Dec 13;63(1):14-31. doi: 10.1044/2019_JSLHR-19-00162. Print 2020 Jan 22.

  PMID: 31841365 BACKGROUND

• Scherer NJ, Boyce S, Martin G. Pre-linguistic children with cleft palate: growth of gesture, vocalization, and word use. Int J Speech Lang Pathol. 2013 Dec;15(6):586-92. doi: 10.3109/17549507.2013.794475. Epub 2013 Sep 27.

  PMID: 24073662 BACKGROUND

• Lane H, Harding S, Wren Y. A systematic review of early speech interventions for children with cleft palate. Int J Lang Commun Disord. 2022 Jan;57(1):226-245. doi: 10.1111/1460-6984.12683. Epub 2021 Nov 12.

  PMID: 34767284 BACKGROUND

• Bessell A, Sell D, Whiting P, Roulstone S, Albery L, Persson M, Verhoeven A, Burke M, Ness AR. Speech and language therapy interventions for children with cleft palate: a systematic review. Cleft Palate Craniofac J. 2013 Jan;50(1):e1-e17. doi: 10.1597/11-202. Epub 2012 Mar 20.

  PMID: 22433039 BACKGROUND

• Chapman KL, Hardin-Jones M, Halter KA. The relationship between early speech and later speech and language performance for children with cleft lip and palate. Clin Linguist Phon. 2003 Apr-May;17(3):173-97. doi: 10.1080/0269920021000047864.

  PMID: 12858838 BACKGROUND

• Frey JR, Kaiser AP, Scherer NJ. The Influences of Child Intelligibility and Rate on Caregiver Responses to Toddlers With and Without Cleft Palate. Cleft Palate Craniofac J. 2018 Feb;55(2):276-286. doi: 10.1177/1055665617727000. Epub 2017 Dec 14.

  PMID: 29351026 BACKGROUND

MeSH Terms

Conditions

Cleft Palate; Gestures; Speech

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Kinesics; Nonverbal Communication; Communication; Behavior; Verbal Behavior

Study Officials

• Kristiane Van Lierde, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Bettens, PhD

CONTACT

+32 9 332 94 26; Kim.Bettens@UGent.be

Kristiane Van Lierde, PhD

CONTACT

+32 9 332 23 91; Kristiane.Vanlierde@UGent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is a two-centre, randomized, parallel-group, longitudinal, controlled trial. Treatment allocation is in a 1:1:1:ratio. Children are randomized to either an infant sign training group (IST group), a verbal training group (VT group) or no intervention control group (C group). The aim is to demonstrate superiority of the active intervention (IST group) compared with control (VT group and C group).

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 22, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)