Communication Outcomes for South African Children With Developmental Disabilities
Condition: Developmental Disability
MeSH terms: Developmental Disabilities
Study type: Interventional

Summary: 
      The goal is to remediate speech and language disorders early in the lives of South African
      children with significant developmental disorders (DD) by enhancing the health care service
      delivery system to better serve families across diverse backgrounds. This study assesses a
      new hybrid intervention to promote better communication skills for both the child and
      caregiver. The hybrid intervention includes a mobile health technology (MHT) web-based tablet
      protocol that assists parents/caregivers in communicating with their children on a daily
      basis at home over a 12-week period in addition to the current standard of care intervention,
      a 30-minute speech-language therapy session at the secondary/tertiary hospitals once a month.
      The hybrid intervention adds to the child's monthly therapy session by providing
      parents/caregivers with instruction about communication with their children via a sequenced
      web-based tablet protocol across a 12 week time period and face-to-face monthly follow-up at
      the hospital where the child receives therapy. Fifty parent/caregiver-child pairs (25 per
      group) will be assigned to either the hybrid intervention or the standard of care
      intervention. Child receptive and expressive language skills, child and parent/caregiver
      communication interactions and parent/caregiver and speech therapist satisfaction with child
      communication will be measured prior to the intervention and then again at the end of the
      12-week period. The effects of the hybrid intervention and standard of care intervention on
      child communication skills, caregiver perception and satisfaction and speech therapist
      perception and satisfaction will be measured. The expectation is that the new MHT enhanced
      hybrid intervention program that is applicable and deliverable in culturally and
      linguistically diverse settings will enhance the child's receptive and expressive
      communication skills and result in greater parent/caregiver and speech therapist satisfaction
      related to the child. The impact includes enhanced health care service delivery to South
      African children with DD and their families so as to better serve the children with DD by
      remediating speech and language disorders on a daily basis.
    

Detailed description: 
      Children with developmental disorders (DD), such as intellectual disability, autism spectrum
      disorder, cerebral palsy and other genetic disorders, that affect development and
      functioning, are at extremely high risk for developing speech and language disorders
      secondary to their primary condition. Speech and language disorders result in great
      difficulty communicating with others including primary caregivers, families, peers, and
      health care providers. These disorders and resulting communication difficulties negatively
      impact the child's growth, quality of life, long-term development, and later employment
      reducing the child's ability to contribute to society. Critical barriers to progress in
      intervention to remediate these difficulties, in countries such as South Africa, are that (1)
      children with DD and their families often live far from secondary and tertiary hospitals
      where speech and language intervention services are provided, (2) the families have diverse
      linguistic backgrounds and (3) health care providers have overwhelmingly large caseloads that
      result in reduced access to interventions. These issues impact the delivery of services to
      children with DD, whose speech, language and communication skills are significantly delayed
      and negatively affect the children's ability to participate, develop and learn at home and in
      the community.

      This clinical trial will improve scientific knowledge about the effects of communication
      intervention on children's development by enhancing health care service delivery via mobile
      health technology (MHT) to South African children with DD and differing language backgrounds
      and their families by remediating speech and language disorders. This project will provide
      empirical data about the intervention approach and child and caregiver communication outcomes
      across languages that can be used as the basis for improvement of existing intervention
      programs. Using a web-based tablet intervention to assist caregivers in communicating with
      their children on a daily basis in the natural environment providing increased intervention
      opportunities for the child; 2) manipulate the interventions to promote and improve
      communication skills for both the child and caregiver; and 3) improve caregiver and
      speech-language pathologist satisfaction with child communication intervention;

      The monthly interventions that the children currently receive at secondary/tertiary hospitals
      will be supplemented by providing caregivers with improved and enhanced training about
      communication with their children. This training will be coupled with regular ongoing
      information via MHT when they return home. This intervention strategy will provide empirical
      evidence for the role of communication intervention enhanced by MHT in assisting caregivers
      to implement communication strategies at home on a regular basis.

      When the proposed aims are achieved, South African health care service delivery related to
      speech and language disorders for children with DD will have an empirically-tested strategy
      for caregiver enhanced intervention of speech and language disorders that can be delivered
      via MHT in local communities in the family's language. This outcome is in line with the
      mission and needs of the Fogarty International Center (FIC) and National Institute of
      Deafness and Other Communication Disorders (NIDCD). Our project will provide a novel approach
      to health care service delivery that will allow for enhanced collaboration between the
      speech-language pathologist and the caregiver.The advantages of the program includes the
      ability to implement communication interventions for children with DD in more locations and
      provide these children with more frequent communication intervention services through the use
      of MHT.

      Approach The approach is to test the hypothesis that children with DD and their primary
      caregivers who receive a communication intervention enhanced by MHT will have more developed
      communication interaction skills than children who receive the standard secondary/tertiary
      care intervention. The interventions will be manipulated and measure child and caregiver
      communication interactions and caregiver and speech-language pathologist satisfaction with
      child communication intervention.

      Design: A randomized control design in which children identified with speech and language
      disorders will be randomly assigned to either an experimental or standard of care group will
      be employed. All children will be assessed on the assessment battery prior to beginning their
      participation and again at the end of the intervention. The Experimental group will receive
      the MHT-enhanced intervention in addition to the standard monthly speech and language
      intervention provided by the clinic and the standard of care group will continue to receive
      only the standard communication intervention for a 12-week-period. After that time, the
      children will be re-assessed to determine changes in communication skills.

      Participants. Young children with DD between the ages of 3-6 years who are receiving speech
      and language services in secondary/tertiary hospitals and their primary caregivers will be
      participants in this study. Fifty children and their primary caregivers (n = 25 Experimental
      Group, n = 25 Standard of Care Group) will be recruited. The caregiver will be asked if they
      are interested in participating in the study. If they agree to participate and complete the
      informed consent,the children will be assessed in their home language using the communication
      assessment battery (CAB) developed during the previous Fogarty grant. The child and caregiver
      will be randomly assigned to the experimental or standard of care groups. Given the previous
      experience, the expectation is that the overwhelming majority of the young children with DD
      that are identified will have significant speech and language impairments in their native
      language. That is, they will primarily be speaking in single words and phrases with varying
      levels of speech comprehension skills and somewhat impaired speech intelligibility. Some of
      the children will not be speaking at all. Thus, the focus of the intervention will typically
      be at the earlier stages of communication development.

      Intervention. The supplemental intervention will consist of a primary caregiver communication
      training program that will be delivered by the research staff in a local primary care
      setting. It will begin with at least two 1-hr sessions in the caregiver's language including
      information about communication development and interaction strategies for communicating with
      the child and practice on the use of the web-based tablet protocol. The caregiver
      communication training program will use video examples of communication interactions, short
      lectures/discussions, written materials as appropriate, and role playing activities to teach
      the caregiver about communicating with the child. It will include segments on: 1)
      characterizing the individual child's receptive and expressive language and communication
      skills (based on the CAB assessment), 2) identifying communication challenges the caregiver
      perceives, 3) identifying initial environments and routines for communication at home, and 4)
      using the tablet intervention to support in home communication with the child including
      practice 4 days per week across routines. Principles of adult learning (i.e., role playing,
      providing opportunities for hands-on practice, creating a open atmosphere in which caregivers
      can ask questions, including a refresher on the previous session's information will be
      included. This approach will enable the caregivers to prepare for implementing the tablet
      protocol at home with the child. The training feedback will use a consistent format beginning
      with asking for caregiver thoughts and perspective about the session, followed by positive
      feedback and areas of needed support and concluding with a summary. Once the caregiver
      returns home with the child, they will use the tablet protocol in a sequential fashion to
      communicate with their child during activities each week. The caregiver can also use the
      tablet to obtain refreshers on communication interaction strategies and how to employ them,
      ask questions and seek guidance. The tablet will also collect data about how the caregiver is
      using it over time. The clinician will have a face-to-face check-in with the caregiver during
      the monthly treatment session at the hospital clinic. This check in will provide an
      opportunity to touch base and gain a sample of how the caregiver child interaction is
      progressing.

      Measures. All children will be assessed using the Communication Assessment Battery (CAB) at
      each time point throughout their participation. The CAB will be supplemented with 1) general
      information (medical history and etiology/diagnosis, socio-economic status, family
      composition, as well as assessment/intervention history including types of intervention) and
      2) the adapted Mullen Early Learning Scales in the child's home language to gain a measure of
      general development from birth up to 68 months of age. This scale measures skills in five
      areas: Gross Motor, Visual Reception, Fine Motor, Expressive Language, and Receptive
      Language.

      CAB. Standardized and observational measures will be employed. The receptive and expressive
      language sub-scales of the Mullen will be used to gain data about the child's language
      skills. The 10 minute caregiver-child interaction sample will permit an examination of the
      communication interaction skills of the child and the caregiver. The communication
      interaction sample will be transcribed using the Systematic Analyses of Language Transcripts
      (SALT) and then employ previously developed coding schemes to measure conversational
      interaction skills for the child and the caregiver (e.g., turn taking, lexical diversity,
      mean length of utterance in words). With respect to caregiver perception of child
      communication, the South African Caregiver Perception of Language Development (SA-CPOLD)
      which provides a specific measure of the caregiver's perception/satisfaction of issues
      related to the child's communication development will be administered. It is a paper and
      pencil survey. On each item, the caregiver responds to a statement using a Likert scale of 1
      (strongly disagree) to 5 (strongly agree). A low score (15) would suggest a relatively
      negative perception of the child's communication development while a high score (45) would
      suggest a relatively positive perception of the child's communication development. A
      comparable questionnaire will be developed to assess the speech-language pathologists
      satisfaction with the MHT-enhanced intervention.

      Measures of Web-based tablet protocol use by caregivers. Each week data will be collected
      from the caregiver on the tablet about their perception of the week's activities.

      Data Analyses. In order to answer the research questions associated with Aim 2 of the study,
      a 2 (intervention group) X 2 (assessment time point) mixed repeated measures ANOVA will be
      conducted. Power analyses indicate that with an alpha of .05 and power of .80, a total sample
      size of 50 participants (25 participants in each group) will be needed to detect a moderate
      effect size.
    

Intervention name(s): Caregiver Intervention; ST Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention is a 3-month (or 12 weeks) sequenced mobile health intervention provided to the parent/caregiver to use at home with the child. It supplements the 30 minute speech and language therapy session provided to the child at the hospital once a month; This intervention is the 30 minute speech and language therapy session provided to the child at the hospital once a month for three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: developmental disability; speech and language disorder; mobile health technology; parent training; communication intervention