Clinical trial NCT05099328: 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
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Language Disorder and Language Impairment
Keywords: Recasting
Book Reading
Parent Coaching
Syntax Stories
Theoretical Domains Framework
Complex Syntax
Expressive language
Language Intervention
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: University of Maryland, College Park
First posted: 2021-10-29
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Accuracy on Elicited Production Probes
timeFrame: 2 week prior to the start of therapy; 2 week post therapy
measure: Change in Comprehension probes (Proportion Looking)
timeFrame: 2 week prior to the start of therapy, 2 week post therapy
measure: Estimated Dose Delivered
timeFrame: During 10 week treatment period
measure: Semi-structured interviews
timeFrame: within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
Secondary outcomes:
measure: Change in Comprehension probes (Pointing)
timeFrame: 2 week prior to the start of therapy, 2 week post therapy
measure: Palatability of treatment
timeFrame: During 10 week treatment period, immediately after each treatment session
measure: Effortfulness of treatment
timeFrame: During 10 week treatment period, immediately after each treatment session
measure: self-efficacy of treatment provider
timeFrame: During 10 week treatment period, immediately after each treatment session
measure: Caregiver grammar knowledge
timeFrame: In the first 1.5 weeks of the treatment period
measure: Theoretical Domains Framework (TDF) Questionnaire
timeFrame: within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
city: College Park
country: United States
facility: University of Maryland
state: Maryland
Study officials:
References: