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Recasting or Book Reading by Parents or Clinicians

Primary Purpose

Developmental Language Disorder and Language Impairment

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Recast Therapy

Syntax Stories

About this trial

This is an interventional treatment trial for Developmental Language Disorder and Language Impairment focused on measuring Recasting, Book Reading, Parent Coaching, Syntax Stories, Theoretical Domains Framework, Complex Syntax, Expressive language, Language Intervention

Eligibility Criteria

4 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Child with DLD

Age: 4-9 years old
Primarily English speaking: as documented by 20% or less exposure to another language, per parent report on the MAPLE
Diagnosed with DLD as documented by standard score below 85 on the Diagnostic Evaluation of Language Variation - Norm Referenced (DELV-NR) composite, a dialect neutral assessment (Seymour, Roeper, de Villiers, & De Villiers, 2005).
Nonverbal Intelligence Quotient (IQ) within typical range as documented by a t-score at or above 35 on the Developmental Abilities Scale (DAS), matrices similarities subscale, (Elliott, 2007).
Hearing within the typical range: Pass screening at 25 dB for 1, 2, 4 kHz; OR scores within the typical range via SoundScouts hearing screening app; OR clear hearing assessment from an audiologist, otolaryngologist, medical doctor, or other professional.
No diagnosis of Autism: Cutoff score of 15 on the Social Communication Questionnaire, (Rutter, Bailey, & Lord, 2003)
No diagnosis of significant sensory-motor concerns or significant psychiatric disorders per parent report
Able to benefit from treatment:
- Score below 40% correct on experimenter developed elicited production probes of passives and object relative clauses
- Producing simple transitive sentences (SVO) and mean length of utterance (MLU) of 2.5 on 100 utterance language sample

Caregiver

Serves as the primary caregiver for an eligible child (may include grandparents, etc.)
Basic literacy skills per self-report
Willing to participate in caregiver training and caregiver-based treatments if child is assigned to that condition
Willing to participate in questionnaires and structured interviews during post-test

Sites / Locations

University of DelawareRecruiting
University of MarylandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Recast Therapy Provided By Clinician

Illustrated Syntax Stories Provided by Clinician

Recast Therapy Provided by a Caregiver

Illustrated Syntax Stories Provided by a Caregiver

Arm Description

Children will be exposed to recasts at a rate of 1/minute. Treatment will be provided 2x/week for 8 weeks for a total of 16 visits (960 recasts). 2 additional weeks are allocated for make up visits. Treatment will be provided by a trained, certified, licensed Speech Language Pathologist (SLP).

Children will be listen to books that are specially scripted to promote the use of a particular syntax target. Treatment will be provided 2x/week for 8 weeks for a total of 16 visits (960 exposures), with 2 books read at each visit. 2 additional weeks are allocated for make up visits. Treatment will be provided by a trained, certified, licensed SLP.

Caregivers will receive two training sessions on how to provide recast therapy and demonstrate their skill at providing recast therapy with support from the clinician. Caregivers will then provide recast therapy at a rate of 1 recast per minute to their children for a minimum of 16 hrs (960 exposures) scheduled at their own convenience.

Caregivers will receive two training sessions on how to provide read illustrated syntax stories to their children and demonstrate their skill at reading these stories with support from the clinician. Caregivers will then read these stories to their children for a minimum of 32 book readings (960 exposures)

Outcomes

Primary Outcome Measures

Change in Accuracy on Elicited Production Probes

Children will respond to 20 item elicited production probes that ask the child to produce the treated structures and a control structure. Elicited Production Probes are highly reliable (ICC >.9), valid measures of children's use of a grammatical form. They have clinical relevance and align with the types of items that occur on standardized tests of language use.

Change in Comprehension probes (Proportion Looking)

Children will participate in an online looking while listening task with 24 items each for the treated target and a control (untreated) structure. Looks to areas of interest on the screen will be recorded. Proportion of time looking at the target picture will be the dependent variable. Looking patterns provide insight into the online processes associated with language comprehension and thus has the potential to inform future studies. These online measures have become well accepted as valid means of understanding comprehension. As far as we are aware there is limited psychometric data available for this age group, but Farris-Trimble & McMurray (2013) have shown these types of paradigms to be reliable.

Estimated Dose Delivered

Adherence (attendance, reported therapy delivery)and treatment fidelity derived from recordings will be combined to estimate the number of exposures/recasts the caregiver provided to the child. This primary measure is important for future studies given the need to understand how well treatment is provided by parents and lab staff for these types of syntactic forms.

Semi-structured interviews

Ethnographic interview examines the caregiver's comfort and understanding and motivation for participation in therapy. Ethnographic interviewing is a valid and reliable technique for qualitative data collection.

Secondary Outcome Measures

Change in Comprehension probes (Pointing)

Children will participate in an online looking while listening task with 24 items each for the treated target and a control (untreated) structure. Points to the correct picture after the conclusion of eye gaze collection will be the dependent variable.

Palatability of treatment

Likert ratings of how much therapy is enjoyed

Effortfulness of treatment

Likert ratings of how effortful therapy is to deliver.

self-efficacy of treatment provider

Likert ratings of how efficacious the provider perceived the activities to be

Caregiver grammar knowledge

Written grammar quiz adapted from Brimo (in press). This questionnaire was previously validated for pre-service SLPs, early childhood educators, and practicing SLPs. The first two sections (implicit knowledge) have been used by Brimo. The last two sections (labeling) have been used in our lab to assess the knowledge of graduate clinicians.

Theoretical Domains Framework (TDF) Questionnaire

Questionnaire aligned with Theoretical Domains Framework constructs that examines the caregiver's comfort and understanding and motivation for participation in therapy. This questionnaire was previously validated for providers of Physical Therapy.

Full Information

NCT ID

NCT05099328

First Posted

October 5, 2021

Last Updated

August 16, 2023

Sponsor

University of Delaware

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD), University of Maryland, College Park

1. Study Identification

Unique Protocol Identification Number

NCT05099328

Brief Title

Recasting or Book Reading by Parents or Clinicians

Official Title

Recasting and Book Reading Under Ideal (Dose-controlled) and Typical (Dose-variable) Conditions: The Role of Fidelity and Adherence in Production and Comprehension Outcomes for Children With DLD

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 28, 2021 (Actual)

Primary Completion Date

August 2026 (Anticipated)

Study Completion Date

August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Delaware

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD), University of Maryland, College Park

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Developmental Language Disorder (DLD) affects approximately seven percent of the population and is characterized by grammatical deficits that cascade into lifelong academic challenges and under-employment. Current treatments for DLD produce good outcomes under ideal, high intensity conditions or when parents have been trained to deliver therapy using intense coaching methods; however, current publicly funded service delivery systems and private-pay reimbursement models do not support treatment being delivered in this ideal fashion for children older than three. This project will examine alternative methods of delivering treatment that may be more feasible under typical conditions and will identify implementation barriers, with the goal of improving long-term outcomes for children with DLD. We hypothesize that feasibility and palatability will influence dose, which will in turn affect the overall language outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Developmental Language Disorder and Language Impairment

Keywords

Recasting, Book Reading, Parent Coaching, Syntax Stories, Theoretical Domains Framework, Complex Syntax, Expressive language, Language Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Children are stratified based on treatment site. Then they are randomly assigned to receive treatment for 1 of 2 targets, using 1 of 4 methods of intervention. Each child is randomly assigned to parent or clinician delivered intervention using books or recast therapy (2x2 design). Then assignment to treatment targets is assigned so that it is evenly distributed within each condition.

Masking

Outcomes Assessor

Masking Description

The outcomes assessor is unaware of the arm to which the child has been assigned and is also unaware of which of two targets are the treatment target.

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Recast Therapy Provided By Clinician

Arm Type

Experimental

Arm Description

Arm Title

Illustrated Syntax Stories Provided by Clinician

Arm Type

Experimental

Arm Description

Arm Title

Recast Therapy Provided by a Caregiver

Arm Type

Experimental

Arm Description

Arm Title

Illustrated Syntax Stories Provided by a Caregiver

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Recast Therapy

Other Intervention Name(s)

Focused Stimulation

Intervention Description

Recast therapy is when a interventionist uses the child's own productions as a platform for restating or recasting the child's speech with corrections or alterations to focus on a particular syntax target.

Intervention Type

Behavioral

Intervention Name(s)

Syntax Stories

Other Intervention Name(s)

Priming, Book Reading

Intervention Description

Syntax stories are specially constructed stories read verbatim designed to teach a syntax target.

Primary Outcome Measure Information:

Title

Change in Accuracy on Elicited Production Probes

Description

Time Frame

2 week prior to the start of therapy; 2 week post therapy

Title

Change in Comprehension probes (Proportion Looking)

Description

Time Frame

2 week prior to the start of therapy, 2 week post therapy

Title

Estimated Dose Delivered

Description

Time Frame

During 10 week treatment period

Title

Semi-structured interviews

Description

Time Frame

within 2 weeks post therapy ( ~12- 14 week mark in study timeline)

Secondary Outcome Measure Information:

Title

Change in Comprehension probes (Pointing)

Description

Time Frame

2 week prior to the start of therapy, 2 week post therapy

Title

Palatability of treatment

Description

Likert ratings of how much therapy is enjoyed

Time Frame

During 10 week treatment period, immediately after each treatment session

Title

Effortfulness of treatment

Description

Likert ratings of how effortful therapy is to deliver.

Time Frame

During 10 week treatment period, immediately after each treatment session

Title

self-efficacy of treatment provider

Description

Likert ratings of how efficacious the provider perceived the activities to be

Time Frame

During 10 week treatment period, immediately after each treatment session

Title

Caregiver grammar knowledge

Description

Time Frame

In the first 1.5 weeks of the treatment period

Title

Theoretical Domains Framework (TDF) Questionnaire

Description

Time Frame

within 2 weeks post therapy ( ~12- 14 week mark in study timeline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

9 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Child with DLD Age: 4-9 years old Primarily English speaking: as documented by 20% or less exposure to another language, per parent report on the MAPLE Diagnosed with DLD as documented by standard score below 85 on the Diagnostic Evaluation of Language Variation - Norm Referenced (DELV-NR) composite, a dialect neutral assessment (Seymour, Roeper, de Villiers, & De Villiers, 2005). Nonverbal Intelligence Quotient (IQ) within typical range as documented by a t-score at or above 35 on the Developmental Abilities Scale (DAS), matrices similarities subscale, (Elliott, 2007). Hearing within the typical range: Pass screening at 25 dB for 1, 2, 4 kHz; OR scores within the typical range via SoundScouts hearing screening app; OR clear hearing assessment from an audiologist, otolaryngologist, medical doctor, or other professional. No diagnosis of Autism: Cutoff score of 15 on the Social Communication Questionnaire, (Rutter, Bailey, & Lord, 2003) No diagnosis of significant sensory-motor concerns or significant psychiatric disorders per parent report Able to benefit from treatment: Score below 60% correct on experimenter developed elicited production probes of passives and object relative clauses Producing simple transitive sentences (SVO) and mean length of utterance (MLU) of 2.5 on 100 utterance language sample Caregiver Serves as the primary caregiver for an eligible child (may include grandparents, etc.) Basic literacy skills per self-report Willing to participate in caregiver training and caregiver-based treatments if child is assigned to that condition Willing to participate in questionnaires and structured interviews during post-test

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amanda O Van Horne, PhD CCC-SLP

Phone

3194710036

ajovh@udel.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Samantha Weatherford, MS CCC-SLP

Phone

302-831-7121

slwslp@udel.edu

Facility Information:

Facility Name

University of Delaware

City

Newark

State/Province

Delaware

ZIP/Postal Code

19711

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amanda J Owen Van Horne, PhD

Phone

302-831-7121

ajovh@udel.edu

First Name & Middle Initial & Last Name & Degree

Samantha Weatherford, MA

Phone

302-831-7121

slwslp@udel.edu

First Name & Middle Initial & Last Name & Degree

Giovana Morini, PhD

Facility Name

University of Maryland

City

College Park

State/Province

Maryland

ZIP/Postal Code

20742

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Ting Huang, PhD

Phone

301-405-4227

ythuang1@umd.edu

First Name & Middle Initial & Last Name & Degree

Jan Edwards, PhD

Phone

301-405-5237

edwards@umd.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Summary results of the primary outcomes for Aims 1 & 2 (elicited production and eye-gaze) will be uploaded within 12 months of the last data collection point for the final participant. We will track and provide information about participant flow. At each phase of participation, we will aggregate and report the following information: non-qualifiers: available screening information and reason for not continuing; qualifying participants who continue in the study: screening & pretest information, by treatment group; participants who complete the study: post-test scores, by treatment group; participants who drop out: reasons given for dropout, along with any adverse events; It is not possible to fully de-identify the interviews utilized in the mixed methods study (Aim 3). Thus, these data will not be shared. Additional data at the individual participant level may be sharable upon request and IRB approval for particular access.

IPD Sharing Time Frame

1 year after final data collection is complete

IPD Sharing Access Criteria

IRB approval for access to data

Learn more about this trial

Recasting or Book Reading by Parents or Clinicians

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