Manipulating Linguistic Complexity to Improve Child Language Treatment Outcomes
Phase: NA
Conditions: Language Development Disorders, Speech Sound Disorder
Sponsor: San Diego State University

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
NCT03977701 
Manipulating Linguistic Complexity to Improve Child Language Treatment Outcomes 
DOCUMENT DATE: FEBRUARY 23, 2019 
NOTE: THIS DOCUMENT REPLACES THE ORIGINAL WHICH WAS THE INCORRECT DOCUMENT 
UPLOADED TO THE SITE. THE DATE OF THE DOCUMENT REMAINS THE SAME. 

Yes
No
Yes
No
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Does the proposed research involve human specimens and/or data?
Yes
No
If Yes, provide an explanation of why the application does not involve human subjects research.
OMB Number: 0925-000
Expiration Date: 03/31/2020
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all screens must be addressed in order to submit for
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Are Human Subjects Involved?
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Is the Project Exempt from Federal
regulations?
(set on Other Project Information tab)
Exemption number:
(set on Other Project Information tab)
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Skip the rest of the PHS Human Subjects and Clinical Trials Information Form
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"Add New Delayed Onset Study"
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50

Study Record: PHS Human Subjects and Clinical Trials Information
* Always required field
Section 1 - Basic Information
1.1. * Study Title (each study title must be unique)
Pho-Mo Complexity Intervention
1.2. * Is this Study Exempt from Federal Regulations?
Yes
No
1.3. Exemption Number
1
2
3
4
5
6
7
8
1.4. * Clinical Trial Questionnaire
If the answers to all four questions below are yes, this study meets the definition of a Clinical Trial.
1.4.a. Does the study involve human participants?
Yes
No
1.4.b. Are the participants prospectively assigned to an intervention?
Yes
No
1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?
Yes
No
1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
Yes
No
1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable
Section 2 - Study Population Characteristics
2.1. Conditions or Focus of Study
Language Development Disorders
Delete
2.2. Eligibility Criteria
Inclusionary Criteria
All participating children must meet the following inclusionary criteria:
- between the ages of 4 and 6 years of age; 
- English monolingual; 
- present with phonological disorder (PD, n = 12), developmental language disorder (DLD, n = 6), or co-occurring PD-DLD (n = 18) (see below for additional criteria 
for inclusion).
Participants will complete a battery of assessment measures. Information gleaned from these measures will be used to further determine eligibility for the proposed 
study, which include both quantitative and qualitative criteria.
In addition, all PD and PD-DLD participants must:
- exhibit 5 or more sounds in error across three or more speech sound manner classes, 
- score less than or equal to 1.5 standard deviations below the mean on the Goldman-Fristoe Test of Articulation 3 (GFTA3), [135] and
- exhibit less than or equal to 20% accuracy on final consonants and clusters independent of tense morphemes.
 
Moreover, all DLD and PD-DLD participants must:
- score less than or equal to 1 standard deviation below the mean on the Preschool Language Scales - Fourth Edition (PLS-4), [136]  a test of expressive and 
receptive language; and
- exhibit a mean length of utterance (MLU) less than or equal to 1 standard deviation below the mean for age- and demographic-matched peers, based on a 
language sample. [4]
Exclusionary Criteria
All participants must:
- not be receiving speech/language services elsewhere,
- pass a binaural hearing screening at 20dB, 
- achieve score above a standard score of 70 on a test of nonverbal cognition (Leiter-R) [137], and 
- have typical intellectual, hearing, social-emotional, and neurological development, per parent report.
In addition, to rule out concomitant difficulty in other domains of language all PD participants must:
- score > 1 standard deviation below the mean on the PLS-4 [136]
- have an MLU > 1 standard deviation below the mean for age- and demographic-matched peers, based on a language sample [4] 
To rule out concomitant difficulty in phonology, the DLD participants must: 
- score > 1.5 standard deviations below the mean on the GFTA3, [135] and
- exhibit fewer than 5 sounds in error and > 20% accuracy on final consonants and clusters independent of tense morphemes.
If the above criteria are not met, a child will be excluded from participation.
2.3. Age Limits
Minimum Age
4
Years
Maximum Age
6
Years
2.4. Inclusion of Women, Minorities, and Children
Inclusion of women_m
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2.5. Recruitment and Retention Plan
RECRUITMENT _ RET
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2.6. Recruitment Status
Not yet recruiting
2.7. Study Timeline
STUDY TIMELINE_Ba
Delete Attachment
  
  
2.8. Enrollment of First Subject
01-May-2019
Anticipated
Inclusion Enrollment Report(s)
Add Inclusion Enrollment Report
Remove Inclusion Enrollment Report
Section 3 - Protection and Monitoring Plans
3.1. Protection of Human Subjects
PROTECTION OF HU
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3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?
Yes
No
N/A
If yes, describe the single IRB plan
Add Attachment
  
3.3. Data and Safety Monitoring Plan
DATA _ SAFETY MON
Delete Attachment
  
  
3.4. Will a Data and Safety Monitoring Board be appointed for this study?
Yes
No
3.5. Overall Structure of the Study Team
OVERALL STRUCTUR
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Section 4 - Protocol Synopsis
4.1. Brief Summary
This proposed research program will evaluate the influence of morpho-phonological interaction in the 
language of children with phonological disorder (PD), those with developmental language disorder 
(DLD), and those children with co-occurring PD and DLD (PD-DLD) through manipulation of 
phonological and morphological complexity in the selection of treatment target words. Experiment 1 
4.2. Study Design
4.2.a. Narrative Study Description
This proposed research program will evaluate the influence of morpho-phonological interaction in the 
language of children with phonological disorder (PD), those with developmental language disorder 
(DLD), and those children with co-occurring PD and DLD (PD-DLD) through manipulation of 
phonological and morphological complexity in the selection of treatment target words. Experiment 1 
4.2.b. Primary Purpose
Treatment
4.2.c. Interventions
Intervention Type
Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
Delete
Name
Language Intervention
Description
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of targeted linguistic forms (consonants, 
consonant clusters, morphemes) following the methodology of Gierut and colleagues (Experiment 1) and of Plante and colleagues 
(Experiment 2). A minimum of 50 (Experiment 2) and up to 100 (Experiment 1) productions will be targeted per 1-hour session.
4.2.d. Study Phase
Phase 3
Is this an NIH-defined Phase III clinical trial?
Yes
No
4.2.e. Intervention Model
Parallel
4.2.f. Masking
Yes
No
Participant
Care Provider
Investigator
Outcomes Assessor
4.2.g. Allocation
Non-randomized
4.3. Outcome Measures
Name
Treatment Probe
Delete
Type
Primary
Time Frame
All participants will complete the Treatment Probe at the start of each treatment session. Maximum 18 sessions.
Description
The Treatment Probe is made of the selected treatment stimuli (verbs) that are consistent with the child's assigned experimental 
condition. These verbs have a final consonant or consonant clusters ("sees" vs. "seats"), and are mono- or bi-morphemic ("tease" 
vs. "sees"). Children will be asked to pronounce each word following presentation of a corresponding picture and a verbal prompt. 
The Treatment Probe allows us to track the effectiveness of treatment on the treated stimuli. 
Name
Generalization Probe
Delete
Type
Primary
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Time Frame
All participants will complete the Generalization Probe during baseline phase (minimum 3 times), after 9 treatment sessions, after the last treatment session, and 2 w
Description
The Generalization Probe consists of words and phrases that target each consonant, cluster, and morpho-syntactic constructs a 
minimum of 10 times across relevant contexts (i.e., word- and utterance-position). The Generalization Probe allows us to track the 
effects of treatment (generalization) to untreated stimuli and to monitor control variables.
4.4. Statistical Design and Power
STATISTICAL DESIGN
Delete Attachment
  
  
4.5. Subject Participation Duration
6 months
4.6. Will the study use an FDA-regulated intervention?
Yes
No
4.6.a. If yes, describe the availability of Investigational Product (IP) and Investigational
New Drug (IND)/Investigational Device Exemption (IDE) status
Add Attachment
  
4.7. Dissemination Plan
DISSEMINATION PLA
Delete Attachment
  
  
Section 5 - Other Clinical Trial-related Attachments
5.1. Other Clinical Trial-related Attachments
Add Attachment
  
53

Inclusion Enrollment Report
1. * Using an Existing Dataset or Resource
Yes
No
2. * Enrollment Location Type
Domestic
Foreign
3. Enrollment Country(ies)
USA: UNITED STATES
Delete
4. Enrollment Location(s)
San Diego, CA
5. Comments
Planned
Racial Categories
Ethnic Categories
Not Hispanic or Latino
Hispanic or Latino
Total
Female
Male
Female
Male
American Indian/Alaska Native
1
1
1
1
4
Asian
1
1
0
0
2
Native Hawaiian or Other Pacific Islander
1
1
0
0
2
Black or African American
1
1
0
0
2
White
7
7
3
3
20
More than One Race
3
3
2
2
10
Total
14
14
6
6
40
Cumulative (Actual)
Racial
Categories
Ethnic Categories
Not Hispanic or Latino
Hispanic or Latino
Unknown/Not Reported Ethnicity
Total
Female
Male
Unknown/
Not Reported
Female
Male
Unknown/
Not Reported
Female
Male
Unknown/
Not Reported
American
Indian/Alaska
Native
Asian
Native
Hawaiian or
Other Pacific
Islander
Black or
African
American
White
More than
One Race
Unknown or
Not Reported
Total
< Previous Report
< Previous Report
< Previous Report
< Previous Report
Report 1 of 1
Next Report >
Next Report >
Next Report >
Next Report >
|<< First Report
|<< First Report
|<< First Report
|<< First Report
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Last Report >>|
Last Report >>|
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54

INCLUSION OF WOMEN AND MINORITIES 
Both male and female children will be recruited equally for this study. We expect that there will be an equal 
number of female and male participants within each group, as prevalence of PD, DLD, and PD-DLD is roughly 
comparable across females and males insofar as the number of participants that we plan to recruit is 
concerned.138,139  
Phonological disorder and developmental language disorder affect individuals of all racial and ethnic 
backgrounds.140 We do not exclude based on these criteria. Given the diversity of San Diego County, and in 
particular San Diego Unified School District, we are able to obtain participants from all ethnic groups. We will 
not exclude any participant on the basis of race or ethnicity. 
INCLUSION OF CHILDREN 
All participants will be children, ages 4 to 6 years. This age range represents a key time in language 
development and diagnosis of phonological disorder (PD) and developmental language disorder (DLD). The 
PI (Barlow) has conducted various treatment studies for children with PD. The Co-PI (Pruitt-Lord) is a 
clinically certified speech-language pathologist, specializing in enhancing clinical assessment, particularly for 
children with DLD. As such, the PI, Co-PI, and the research team have extensive experience conducting 
standardized and non-standardized language testing of children in this age range. In addition, all personnel 
working on this project have completed training in the protection of human subjects. The data will be collected 
within the labs and the university clinic that serve children and include facilities capable of accommodating 
children. The recruitment sites identified within San Diego Unified School District are sufficient to provide the 
targeted number of participants.  
55

RECRUITMENT AND RETENTION PLAN 
Recruitment: 
The participants will be recruited through schools and community organizations but will not be enrolled in any 
other speech/language services elsewhere. Both male and female participants will be recruited, as will children 
from varied racial/ethnic backgrounds. 
Participants will be recruited through long-standing collaborations with schools and community organizations in 
San Diego County (see Letters of Support from San Diego Unified School District [Taps Richard] and SDSU 
Speech-Language Clinic [Lopes]). Permission will be obtained from the school district and local school 
administrators before conducting recruitment efforts. Following protocol that has successfully been 
implemented in the past, we will provide teachers and parent groups at area preschools and community 
centers with information about the project. The study will be announced to prospective caregivers through 
informational packets (e.g., flyer, SDSU Institutional Review Board-approved parental consent forms, 
demographic questionnaire, envelope) sent home with the child. 
Retention: 
Incentives are set at a reasonable rate to cover time and travel, and will be staggered across each participant’s 
enrollment. We will have a part-time clinical research associate devoted to recruitment and retention.  
 
 
 
56

STUDY TIMELINE 
 
 
Year 1 
Year 2 
April 
May-Aug 
Sep-Dec 
Jan-Apr 
May-Aug 
Activity 
Recruitment starts 
(n = 36 participants)  
Continues through 
May of Year 2 
9 participants for 
Summer clinic 
session 
9 participants for 
Fall clinic 
session 
9 participants for 
Spring clinic 
session 
9 participants for 
Summer clinic 
session 
 
 
 
57

PROTECTION OF HUMAN SUBJECTS  
1. Risks to Human Subjects 
a. Human Subjects Involvement, Characteristics, and Design:  
The participants will include 36 English monolingual children between the ages of 4 and 6 years of age with 
phonological disorder (PD, n = 12), developmental language disorder (DLD, n = 6), or co-occurring PD-
DLD (n = 18). The participants will be recruited through schools and community organizations but will not 
be enrolled in any other speech/language services elsewhere. All participants will have typical intellectual, 
hearing, social-emotional, and neurological development, per parent report. Both male and female 
participants will be recruited, as will children from varied racial/ethnic backgrounds.  
Participants in all groups will complete a battery of assessment measures. Information gleaned from these 
measures will be used to further determine eligibility for the proposed study, which include both quantitative 
and qualitative criteria. Specifically, participating children must pass a binaural hearing screening at 20dB, 
and score above a standard score of 70 on a test of nonverbal cognition (Leiter-R).137  
In addition, all PD and PD-DLD participants must exhibit 5 or more sounds in error across three or more 
speech sound manner classes based on performance on the Protocol for the Assessment of English 
Phonotactics (PEEP),82,141 and must score ≤ 1.5 standard deviations below the mean on the Goldman-
Fristoe Test of Articulation 3 (GFTA3).135 PD and PD-DLD participants also must exhibit ≤ 20% accuracy 
on final consonants and clusters independent of tense morphemes, based on performance on the PEEP.141  
Moreover, all DLD and PD-DLD participants must score ≤ 1 standard deviation below the mean on the 
Preschool Language Scales – Fourth Edition (PLS-4), a test of expressive and receptive language.136 DLD 
and PD-DLD participants also must exhibit a mean length of utterance (MLU) ≤ 1 standard deviation below 
the mean for age- and demographic-matched peers, based on a language sample.4 
Finally, to rule out concomitant difficulty in other domains of language, PD participants must score > 1 
standard deviation below the mean on the PLS-4,136 and must have an MLU > 1 standard deviation below 
the mean for age- and demographic-matched peers, based on a language sample.4 To rule out 
concomitant difficulty in phonology, the DLD participants must score > 1.5 standard deviations below the 
mean on the GFTA3135 and exhibit fewer than 5 sounds in error and > 20% accuracy on final consonants 
and clusters independent of tense morphemes, based on performance on the PEEP.141  
b. Study Procedures, Materials, and Potential Risks:  
This study employs a single-subject, staggered multiple-baseline design. Data will include caregiver-
reported demographic data, scores on the standardized tests, digital recordings of subjects’ spontaneous 
language, treatment probes and generalization probes, computerized analyses of speech/language 
samples and probes, and transcribed responses from speech/language samples and probes. All such data 
will be collected following caregiver consent and child assent. Further, all data will be collected at the San 
Diego State University (SDSU) clinic, with the exception of the caregiver report, which may be completed 
by the caregiver at home. 
Screening procedures will include administration of the following: 
 
Caregiver report of child history and language background, 
 
Binaural hearing screening, 
 
Goldman-Fristoe Test of Articulation 3,135 
 
Preschool Language Scales – Fourth Edition (PLS-4),136  
 
Leiter-R,137 
 
Spontaneous language sample, and 
 
Protocol for the Assessment of English Phonotactics.141 
The proposed experiments will be conducted for research purposes only, and access to all data collected 
will be restricted to investigators and research assistants. Prior to accessing data, research assistants will 
be required to complete the Collaborative Institutional Training Initiative (CITI) Program. 
Following these initial screening procedures, those children who meet the eligibility criteria above will be 
classified as having PD, DLD, or PD-DLD, per those criteria. They will then be assigned to a particular 
treatment condition (see Table 1). PD children will be assigned to one of four conditions of Experiment 1 
(n=3 per condition) and DLD children will be assigned to one of two conditions of Experiment 2 (n=3 per 
58

condition). PD-DLD children will be assigned to one of four conditions of Experiment 1 (n=3 per condition) 
or one of two conditions of Experiment 2 (n=3 per condition). Following treatment condition assignment, 
specific treatment target verb stimuli will be identified for each child.  
The next set of procedures involve the following, with 1-hour sessions occurring three times weekly (see 
also C.2.2. Experimental design): 
 
Baseline testing phase, to include administration of the Generalization Probe (a minimum of three 
baseline sessions per child); 
 
Treatment phase (maximum 18 sessions), to include 
o Treatment Probe administered at the start of each session and 
o Generalization Probe collected after 9 treatment sessions; 
 
Post-treatment testing phase, to include Generalization Probe collected immediately following 
treatment, and at 2 weeks and 2 months posttreatment.  
Following completion of the post-treatment testing, children will be dismissed from participation in the 
research program. Referrals, if needed, for further speech/language services will be provided.  
The risks of the procedures associated with the proposed project are minimal and typical of children 
receiving speech/language services in the schools, with the exception that there is more testing involved, 
treatment occurs more frequently (three times per week as compared to 1 to 2 times per week in a typical 
school setting), and the procedures will occur at the university clinic. No individual testing or treatment 
session will last longer than 1 hour. Risks to the children may include boredom or fatigue. The children will 
also be informed that they can take breaks or permanently end any session. 
Additionally, the frequent visits to the university for participation in the study may incur costs to participants’ 
caregivers in terms of their time and transportation. For that reason, we will offer incentives for participation 
in the study. 
2. Adequacy of Protection Against Risk 
a. Informed Consent and Assent: To ensure voluntary participation, the caregivers of potential participants 
will be asked to return the consent forms in envelopes provided with the informational packet. The consent 
form will be written in culturally appropriate language that is straightforward and easy to understand. 
Copies of the signed consent forms will be returned to the caregivers with a reminder of how to contact the 
research program if they have any questions or concerns. Child assent will be obtained verbally before 
each session begins. 
b. Protections Against Risk: Confidentiality will be maintained by assigning random subject identification 
numbers when consent forms are returned. This number will be used for all data analyses, testing 
information, and record keeping. The signed consent forms and list of names linked to the codes will be 
stored in a locked file cabinet only available to the principal investigators. The written and recorded data 
will be stored in a separate locked cabinet, available only to the research personnel directly involved in this 
study. Backups of the digital data will be stored on a password-protected server in the College of Health 
and Human Services at SDSU. 
The risks of the proposed project to the children are minimal and do not exceed those that occur in 
everyday school life. Fatigue will be minimized by limiting the individual sessions to 1 hour and providing 
breaks as needed. Costs associated with time and travel will be offset by incentives provided to 
participants’ caregivers.  
c. Vulnerable Subjects: Because the purpose of the proposed study is to evaluate treatment target selection 
for children with PD and/or DLD, all participants will be children, ages 4 to 6 years. This age represents a 
key time in language development and diagnosis of PD and DLD. The PI (Barlow) has conducted various 
treatment studies for children with PD. The Co-PI (Pruitt-Lord) is a clinically certified speech-language 
pathologist, specializing in enhancing clinical assessment, particularly for children with DLD. As such, the 
PI, Co-PI, and the research team have extensive experience conducting standardized and non-
standardized language testing of children in this age range. In addition, all personnel working on this 
project have completed the CITI training program in the protection of human subjects.  
59

3. Potential Benefits of the Proposed Research to Human Subjects and Others 
Potential benefits to participating children include speech, language, and hearing screening and treatment, as 
well as incentive payments given to caregivers as compensation for their time and transportation. The student 
research assistants will also gain valuable clinical and research skills through their involvement with this 
project. 
4. Importance of the Knowledge to be Gained  
The high-incidence disorders PD, DLD, and PD-DLD directly impact a child’s ability to communicate and are 
among the most prevalent developmental disorders. The experiments proposed manipulate the complexity of 
treatment targets to identify the most efficacious treatment approaches for children who present with these 
disorders. Our proposal would reveal the nature of interactions between sound and structure in language for 
these children and will serve as the basis for future treatment studies that will allow children to benefit from 
treatment in less time than what has been shown to date. 
 
 
60

DATA AND SAFETY MONITORING PLAN 
The Data and Safety Monitoring Plan (DSMP) below will align with the policies and guidelines of the San Diego 
State University Human Research Protection Program, from which approval will be obtained prior to any 
recruitment of study participants begins.  
Confidentiality 
The study data will consist of digital recordings of children’s speech, electronic transcripts of their utterances, 
and paper records (from study tests). All data will be viewed only by investigators and research assistants and 
will be entered into a database under password protection. All physical data files will be stored in protected 
locations and under lock and key except when being viewed by a member of the research team, and will not 
leave the Phonological Typologies and Child Language Development, Disorders and Disparities Labs. Four-
digit participant IDs will replace individuals’ names for all purposes, and therefore subject confidentiality will be 
maintained. Participants will never be identified by name in any publication or report. 
Fidelity and Reliability 
Periodic fidelity checks will be implemented by the PI, Co-PI, clinical research associate, or senior graduate 
research assistant to ensure that treatment protocols are administered consistently across participants. For the 
first 3 participants who enroll in each experiment, weekly checks will occur to verify that procedures and 
activities are uniform across sessions, and that all participants are given the opportunity to attempt 
approximately 96 productions per session. These checks will be based on observation of live sessions, review 
of recorded sessions, and data records. Fidelity checks with subsequent participants will occur during the first 
treatment week and then every 2 weeks in the same manner. For reliability, 20% of all pretreatment, baseline, 
treatment, and generalization data from each child will be re-transcribed and re-coded by a second judge 
(research assistant) trained in SALT,4 Phon,3 and IPA notation. Samples with reliability scores <85% will be re-
transcribed and/or re-coded completely. 
Data and Safety Monitoring Board 
The Data and Safety Monitoring Board (DSMB) will consist of independent researchers at San Diego State 
University who conduct research with human subjects, including vulnerable populations (i.e., children, 
individuals with neurological impairment, the elderly), and who also engage in clinical research with individuals 
with communication disorders. They will monitor and evaluate study activities on a quarterly basis to ensure 
that the DSMP is being followed to the letter. This will entail observing clinical sessions with the study 
participants, inspection of the research facilities to ensure proper storage of confidential information, and 
verifying that fidelity and reliability checks are occurring as described above. 
The procedures that will be used with the study participants are standard procedures used in current clinical 
practice. As they are behavioral in nature, they constitute low-risk trials. Further, the PI and Co-PI will not be 
blinded to the participants’ assignments to study conditions, and therefore will be able to monitor all human 
subject interactions on a weekly, ongoing basis to ensure that the DSMP is being followed. Updates on this 
monitoring will be reported to the DMSB on a monthly basis. 
Should any Adverse Events (AEs) or Unanticipated Problems (UPs) arise, they will be reported to the 
university Human Research Protection Program, following the guidelines delineated below. In addition, the PI 
will also report any such AE or UP to the NIDCD, the NIH Office of Biotechnology Activities and the Food and 
Drug Administration. 
Stopping Rules 
The study will be discontinued prior to completion in the event that the intervention procedures are directly 
associated with AEs, suggesting that the intervention is unsafe. 
San Diego State University Adverse Event Reporting 
The SDSU Human Research Protection Program’s guidelines for reporting AEs and UPs are as follows 
[http://research.sdsu.edu/research_affairs/human_subjects/guidance]  
A. Adverse Event and Unanticipated Problems Reporting 
1. Reportable Events/Problems 
a. All unanticipated problems involving risk 
b. Unanticipated Serious Adverse Events 
61

Serious adverse events must be reported to the IRB immediately at least within 48 hours of the 
event. Serious adverse events are defined as(i) events that have resulted in death; (ii) are life 
threatening; iii) require inpatient hospitalization; (iv) result in persistent or significant 
disability/incapacity, (v) result in a congenital anomaly/birth defect; or (vi) any other adverse event 
that, based upon appropriate medical judgment, may jeopardize the subject’s health and may 
require medical or surgical intervention to prevent one of the other outcomes listed in this definition 
(examples of such events include allergic bronchospasm requiring intensive treatment in the 
emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse). All other problems (listed 
below) must be reported to the SDSU IRB within 5 days. 
c. Any apparent serious and/or continuing non-compliance. 
d. Protocol deviations 
e. Any unauthorized use, disclosure, removal, theft, or loss of PHI or individually identifiable private 
information. 
Examples of losses under item (e) above include but may not be limited to: 
a. Signed consent forms, data collection forms or case report forms containing PHI 
b. The loss or theft of a laptop, flash drive, smart phone or tablet containing private identifiable 
information. 
B. How to Submit a Report of a Problem in Research 
Please access the Adverse Event Report form on the HRPP website at: 
https://newscenter.sdsu.edu/researchaffairs/files/03111-SDSU_HRPP_Adverse_Event_Form.pdf  and 
submit the form as an email attachment to irb@mail.sdsu.edu.  For more information contact the HRPP 
office at 619-594-6622. 
C. Review of a Report of a Problem in Research 
The IRB will review the report to determine if the adverse event or problem is serious, unanticipated and 
related to the research. The IRB Chairperson will also determine if immediate action is warranted. 
D. Convened IRB Review of a Report 
When the IRB Chairperson determines the event is serious, unanticipated and related, the report will be 
reviewed at next IRB meeting. The Senior Research Affairs [IRB] Analyst will assign a primary reviewer to 
review and present the event at the meeting. The primary reviewer as well as all IRB members have 
access to the vIRB and are expected to review the report in prior to the meeting. 
The IRB will consider the following actions: 
1. Modification to the protocol 
2. Modification of information in provided in the informed consent document and during participant 
consenting 
3. Providing additional information to past study participants 
4. Notification of current study participants if the new information might affect their willingness to continue 
participation 
5. Requiring the re-consent of currently enrolled participants 
6. Modification to the continuing review schedule 
7. Monitoring of the research 
8. Monitoring of the consent process 
9. Suspension of research 
10. Termination of research 
E. For Cause Suspension or Termination of IRB Approval of Research 
The IRB Chairperson or designee may require an immediate, temporary suspension of enrollment of new 
participants and/or continued participation of previously enrolled participants, pending convened IRB 
review of an adverse event, unanticipated problem involving risk or research that is not being conducted in 
accordance with IRB requirements. 
62

Upon review, if the IRB determines there is an unanticipated problem involving risk, or that there is serious 
continuing non-compliance, they may vote to suspend or terminate approval of the research. 
The IRB will notify the PI in writing of such suspensions or terminations. The correspondence will include a 
statement for the reasons for suspension or termination. The PI will be provided with an opportunity to 
respond to the IRB in person or in writing. 
F. Mandatory Reporting to SDSU Institutional Officials and External Agencies 
Reports of any suspension or termination of IRB approval will be promptly reported to the appropriate 
institutional officials, the HHS agency that supports the research, and OHRP. The reports will include the 
reasons for the IRB’s action as well as: 
1. The name of the institution(s) (e.g., university, hospital, foundation, school, etc.) conducting the 
research project; 
2. The title of the research project and the title of any related grant, contract, or cooperative agreement; 
3. The name of the principal investigator for the research project; 
4. The number of the research project assigned by the IRB and the number of the applicable HHS 
award(s) (grant, contract, or cooperative agreement); 
5. A detailed description of the reason for the suspension or termination; and 
6. The actions the institution is taking or plans to take to address the suspension or termination (e.g., 
investigate alleged noncompliance, educate the investigator, educate all research staff, require 
monitoring of the investigator or the research project, etc.) 
When an IRB (a) suspends or terminates its approval during the period for which IRB approval had already 
been given or (b) disapproves a research project at the time of continuing review, the IRB should establish 
procedures to ensure that the rights and welfare of currently enrolled subjects are protected, subjects are 
not put at risk, and subjects receive appropriate care, if indicated, during the period of suspension or 
following the cessation of the research. This is particularly important in the context of clinical trials. For 
example, the IRB, in consultation with the investigator and the subjects’ treating physicians (if not the 
investigator), may need to determine whether it is in the best interests of currently enrolled subjects to (a) 
continue receiving the interventions that were being administered to subjects under the research project, 
(b) be transferred to another institution engaged in the research so that participation of the subjects in the 
research may continue, or (c) be transitioned to medical management outside of the research context. 
Continuation of subjects on interventions that were being administered under the research project may be 
appropriate at least temporarily, for example, when those interventions hold out the prospect of direct 
benefit to the subjects or when withholding those interventions poses increased risk to the subjects. If the 
IRB decides that already enrolled subjects should continue to receive the interventions that were being 
administered to subjects under the research project, data collection (especially safety information) should 
also continue for such subjects. 
In the case of an adverse event or other research related problem, the IRB will determine whether the 
investigator has developed appropriate measures to remedy the problem and to avoid the occurrence of a 
similar problem in the future. If the IRB determines that the adverse event [or other problem] is related to 
the research and that the problem was unanticipated, the PI will be asked at a minimum to modify informed 
consent procedures so that current participants are notified of the event so that they may determine 
whether or not they wish to continue their participation. The investigator may also be required to revise the 
informed consent process for use with future participants so that all foreseeable risks that are involved in 
the study are described. In addition, the IRB will determine on a case-by-case basis whether additional 
substantive changes such as major revisions to the protocol are required. 
Federal law may also require the IRB to report the incident to the Office of Human Research Protections 
(OHRP) (45 CFR 46.103(a)). The IRB will report the incident to OHRP when it has been determined that 
the adverse event is also considered an unanticipated problem and therefore meets all of the following 
criteria: 
1. The adverse event is unexpected in nature, severity and frequency; 
2. The adverse event is related or possibly related to participation in the research; and 
3. The adverse event suggests that the research places subjects or others at greater risk of physical or 
psychological harm than was previously known or recognized. 
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(Modified from OHRP’s “Algorithm for Determining Whether an Adverse Event is an Unanticipated 
Problem” available: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm, p. 10). 
Adverse events that do not meet the criteria as described above will not be reported to OHRP; however the 
SDSU IRB maintains that authority to require protocol revisions or suspend or terminate any protocol that is 
not being conducted in accordance with the SDSU IRB requirements for approved research or that has 
been associated with unexpected serious harm to subjects. The IRB will promptly notify the investigator if 
this determination is made. 
G. Recognizing a Deviation from an IRB Approved Protocol 
The IRB presumes the PI is implementing protocol procedures consistent with IRB approval. However, the 
IRB recognizes that deviations and exceptions to approved IRB protocols may occur. A protocol deviation 
occurs when there is inconsistency between the procedures carried out in a study and the procedures 
stated in the research protocol, or when regulations regarding the manner in which research is being 
conducted are not being followed. Protocol deviations may directly harm or present the risk of harm to 
human subjects, or may be administrative in nature, such as those related to data or record keeping. As 
indicated in section XI, protocol deviations should be reported to the IRB. 
 
 
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STATISTICAL DESIGN AND POWER 
This study employs a single-subject, staggered, multiple-baseline design.82,117-119 Consistent with this design, it 
includes a standard (minimum) number of subjects per study condition (n=3). Experiment 1 includes four 
different treatment conditions and two populations, and thus includes 24 participants (3 participants x 4 
conditions x 2 populations). Experiment 2 includes two different treatment conditions and two populations, and 
thus includes 12 participants (3 participants x 2 conditions x 2 populations).  
Consistent with the staggered MBL design, analyses will focus on individual performance. We will complete a 
visual inspection of accuracy data plotted over time for each child.116,118,132 Level, slope, and variability of 
accuracy scores across all data points will be evaluated within and across children to compare different legs of 
the multiple baseline within and across treatment conditions for each experiment.118,119,133 This type of 
individual case data allows us to examine individual differences in performance during and following treatment 
and is particularly meaningful to practicing speech-language pathologists.  
In addition, clinically meaningful effect size will be determined by calculating the difference in mean accuracy 
across pretreatment probes and mean accuracy posttreatment divided by the standard deviation of accuracy 
post-treatment on the Generalization Probe.73,116 Effect sizes obtained for each treatment condition in each 
experiment will be compared relative to one another, and to results from published studies reporting effect size. 
 
 
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