Effect of Infant Sign Training on Speech-language Development

NCT ID: NCT06143254

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2027-10-30

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.

Conditions

Cleft Palate Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Infant sign training

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Verbal training

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Infant sign training

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.

Intervention Type: BEHAVIORAL

Verbal training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristiane Van Lierde, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, East Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Kim Bettens, PhD

Role: CONTACT

Kim.Bettens@UGent.be

+32 9 332 94 26

Kristiane Van Lierde, PhD

Role: CONTACT

Kristiane.Vanlierde@UGent.be

+32 9 332 23 91

Facility Contacts

Kim Bettens, PhD

Role: primary

Kim.Bettens@UGent.be

+32 9 332 94 26

Kristiane Van Lierde, PhD

Role: backup

Kristiane.Vanlierde@UGent.be

+32 9 332 23 91

References

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.

Reference Type: BACKGROUND

PMID: 37376898 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31841365 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24073662 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34767284 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22433039 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12858838 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29351026 (View on PubMed)

Other Identifiers

ONZ-2022-0581

Identifier Type: -

Identifier Source: org_study_id