Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities
Phase: NA
Conditions: Stress
Sponsor: Massachusetts General Hospital

 
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DETAILED PROTOCOL 
 
9/14/16 
 
NCT# 02772432 
 
Development of a Resiliency Training Program for Parents of Children With Specific 
Learning Disabilities 
 
 

 
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PARTNERS HUMAN RESEARCH COMMITTEE DETAILED PROTOCOL 
 
Date: 9/14/16 
 
I. BACKGROUND AND SIGNIFICANCE 
 
 
According to the 2011/12 National Survey of Children’s Health, 14.6 million children in 
the U.S. have special health care needs (e.g., learning disability, ADD/ADHD, developmental 
delays, chronic mental or physical health conditions); CSHCN comprise between 14.4%-25.6% 
of the child population in the United States.1 Having a child with special health care needs 
(CSHCN) is associated with an increased risk of problems with emotional and physical health 
and social well-being. Parents of CSHCN are also at an increased risk for not being employed, 
2,3,4,5 financial stress, 6,7,8 and poor health-related quality of life (HRQoL).7  
There is growing literature on the increased levels of parental stress associated with 
caring for CSHCN.  One study found that chronic stress, as measured by the duration of having a 
CSHCN, was associated with an increase in clinical aging, determined by telomeres (caps at the 
end of each strand of DNA that protect chromosomes during aging) sequences.9 A review article 
provides a comprehensive overview of the links between high levels of parental stress among 
parents of children with intellectual and developmental disabilities and child health and well-
being.10 Furthermore, a recent study documented that parents of CSHCN feel socially isolated.1 
Therefore, having a child with special health care needs (CSHCN) is associated with an 
increased risk of problems with emotional and physical health and social well-being. Resiliency 
is a multidimensional construct that refers to the ability to maintain adaptation and effective 
functioning when faced with stressors.  
Resiliency provides a framework for understanding the adjustment to stress as a dynamic 
process. Allostasis refers to the capacity to maintain stability of physiological systems in the face 
of adversity.11 When exposed to chronic stressors, such as care for a CSHCN, individuals expend 
a great deal of energy attempting to maintain allostasis; this can lead to the metabolic wear and 
tear described as allostatic load. Evidence is accumulating that this wear and tear is mediated by 
changes in basal stress system activity and by effects of these changes on dependent systems.12 
Allostatic load and resilience can therefore be assessed by measuring basal stress system activity 
(HPA axis and salivary alpha-amylase). 
 
Thus, research to reduce these parents’ exposure to stress and, moreover, improve 
parental responses to stress, may improve the wellbeing of both parents and their children. Yet, a 
treatment focused on the psychosocial needs of parents of children CSHCN, particularly for 
parents of children with learning disabilities has not been developed. Given the less disruptive 
nature of a learning disability diagnosis, there are fewer resources and support systems in place. 
Based on qualitative interviews with experts and parents of children with learning disabilities 
(conducted in phase I of this study #2016P000423), there is a need for skills-based support for 
parents that can be easily accessible, via virtual delivery.  
 
Research is warranted to examine and intervene upon parental stress. This study aims to 
design and develop a resiliency intervention to provide support to parents of children with 
learning disabilities, an under-represented and less severe population of childhood disabilities.  
 
This intervention will be a modified version of Dr. Park’s evidence-based 8-week 
multimodal treatment which is designed to promote adaptation to stress and promotion of 

 
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resiliency. This study will refine an 8-session group virtual-delivered resiliency treatment 
program consisting of 8 virtual group 1 hour sessions. The goal of this study would be to 
advance our ultimate objective to implement a national parental resiliency program. 
 
 
II. SPECIFIC AIMS 
 
The proposed research has the following objectives: 
 
Specific Aim 1 (Phase II): Informed by Phase I findings, (approved in a previous IRB protocol 
#2016P000423), we aim to develop and determine the feasibility (by assessing the number of 
sessions attended and adherence to Relaxation Response practice) and acceptability (assessed 
using the Participant Feedback Survey) of an 8-session Relaxation Response Resiliency 
(SMART-3RP) program for parents of children with learning disabilities.  
 
Hypothesis: The SMART-3RP virtual delivery will be feasible to implement and 
acceptable to parents of children with learning disabilities.  
 
Primary Aim 2 (Phase III): To test the effectiveness of a pilot waitlist controlled trial on 
improving resiliency, as measured using the General Self-Efficacy Questionnaire, Current 
Experiences Scale, and the Visual Analogue 0-10 scales (including stress, distress, coping, and 
physical discomfort), and on improving stress reactivity (as measured by the Measure of Current 
Status-A), growth enhancement (as measured by the Cognitive and Affective Mindfulness Scale-
Revised), and parental stress (as measured by the Parental Stress Scale).  This will be assessed by 
comparing Baseline-3 mo. scores on primary and secondary outcome measures between the 
Immediate and Waitlist control groups.   
 
Primary Hypothesis: Patients randomized to the Immediate group will report 
significantly greater scores on the primary outcomes (measures of resilience) and on the 
secondary outcomes (measures of stress reactivity, growth enhancement, and parental 
stress) at 3 mo. post enrollment.     
 
Secondary Aims: Among participants randomized to both conditions, to investigate the extent 
of pre-post changes in primary and secondary outcomes (Immediate: assessments from baseline-
3 mo.; Waitlist: from 3-6 mo.).  
 
Secondary Hypothesis: Scores on primary and secondary outcome measures will 
improve from pre-post intervention.  
  
Secondary Aim 2: Among immediate condition group only, to assess whether end-of-treatment 
(3 mo. post enrollment) improvements will be sustained at 6-mo. post enrollment. 
 
Hypothesis: These end-of-treatment effects will show sustained improvement on primary 
and secondary outcome measures from 3 to 6-mo. Post enrollment.   
 
Secondary Aim 3: To pilot test the end-of-treatment effects of the SMART-3RP on parents’ 
stress levels using hair cortisol. A mixed effects models approach will be used to examine group 

 
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differences in hair cortisol concentrations (HCC) at baseline and 3 mo. post enrollment. Pearson 
correlation or Spearman’s rank correlation will be used to examine the association of HCC with 
each of our psychological outcomes. 
 
Hypothesis: Parents randomized to the Immediate group will show improvements in 
biomarkers of stress system function, in particular the hypothalamus pituitary adrenal 
(HPA) axis and sympathetic nervous system (SNS) relative to baseline. It is expected that 
stress-related alterations will be found in parents before the intervention and will improve 
in those individuals that respond favorably to the treatment. Biomarkers will thus allow 
an additional level of testing for chronic stress, and efficiency of the intervention; 
measuring basal HPA axis and SNS activity further allows us to draw conclusions about 
the adverse long-term health effects of chronic stress and to evaluate the efficiency of the 
intervention in ameliorating such biological changes.  
 
 
III. SUBJECT SELECTION 
 
We will recruit through our contacts in the community including other MGH clinicians, as well 
as through local and national support groups and list serves using IRB approved recruitment 
materials. MGH child psychologists may also refer potentially eligible participants. Interested 
participants may call or email the study staff to learn more about the study.   
 
The current study will employ a pretest-posttest, pilot waitlist controlled design to test the 3RP 
for parents of children with learning disabilities. Participants will be recruited from local, 
national, and international organizations, school systems, and hospital clinics.  
 
 
Inclusion/Exclusion Criteria 
 
Inclusion criteria are: 
1) Being the parent of at least one child with a learning disability 
2) Age 18 or older 
3) Can read and speak English  
 
One or more of the following exclusion criteria will render an individual ineligible: 
1) Being the parent of a child with a severe mental or physical disability up to the discretion 
of the principal investigator  
2) Regular use of corticosteroids at the discretion of the Principal Investigator 
3) Unable or unwilling to sign the informed consent documents 
4) Unable or unwilling to participate in an intervention delivered via videoconferencing. 
 
 
Recruitment 
 
A total of approximately 70 participants will be recruited for this study. Both males and females 
from diverse racial and ethnic backgrounds will be recruited using IRB approved procedures. 
Potential participants will be recruited from our contacts in the community including other MGH 

 
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clinicians, as well as through local and national support groups and list serves using IRB 
approved recruitment materials. MGH child psychologists may also refer potentially eligible 
participants. In each case, interested participants will be directed to our pre-screen REDCap 
survey and will be given the option to contact the study staff to learn more about the study.  
 
IV. SUBJECT ENROLLMENT 
 
Methods of enrollment 
Participants will contact the PI or study staff by telephone, email, or by completing our IRB 
approved pre-screen REDCap survey in response to advertisements.  Subject will be contacted 
by phone, informed about the study and given a pre-screen REDCap to determine whether they 
meet inclusion/exclusion criteria (see the attached pre-screening questionnaire). Subjects may 
also be referred to the study. Subjects must respond “yes” to all inclusion criteria and “no” to all 
exclusion criteria to be eligible for the study. Eligible participants will be consented and will 
complete the baseline survey online into REDCap, a secure, web-based application designed to 
support data capture for research studies.   
 
Randomization 
After enrollment, participants will be randomized to the Immediate intervention group (IG) or 
Waitlist control group (WG). Randomization will be conducted using a random plan generator, 
with 1:1 randomization. The WG will begin their program approximately 3 months after the 
SMART-3RP group. For both groups, the intervention will last approximately 8 weeks, weekly 
with groups meeting once per week for approximately 1 hour. 
 
Informed consent process 
Eligible and interested participants will be sent a consent form and scheduled for a phone 
consent.  Informed consent and authorization will be obtained and documented through use of a 
written consent form approved by the Partners Human Research Committee (PHRC) and signed 
by the participant. The PI or qualified study staff will complete informed consent procedures.  
 
Participants will be asked to read the consent form fully on their own before discussing the 
consent form with a study staff member (either on the phone or using videoconferencing). The 
participant will have the opportunity to ask any and all questions about the study. Once all 
questions have been addressed, they will sign the consent form and send it to the study staff 
member (either via email, scan, fax, or mail). The study staff member will then sign the 
participant’s signed copy and send a copy back to the participant for their records. As informed 
consent is a continuous process, participants will be invited to ask questions about their 
participation at any point over the course of the study.  
 
The consent form will include a description of all study procedures, information about potential 
risks and benefits of participation, and study contact information (including that of the IRB) in 
case questions arise at a later time. The consent form will also explicitly state that study 
participation is voluntary, and that participants may refuse to answer any questions that make 
them uncomfortable, and may discontinue participation at any time. The consent will also 
explicitly state that this intervention is psycho-educational and is not clinical care.  
In addition, special attention will be given during the consent process to the implications of 
receiving an intervention online via videoconferencing services. Subjects will be explicitly 

 
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informed that videoconferencing services provide secure HIPAA-compliant videoconferencing 
software. We will explain to participants that although we will do our best to ensure 
confidentiality on our end, we cannot guarantee 100% that other group members will not share 
the content of the group. Participants will also be advised to wear headphones and sit in a quiet 
place to protect their own, and other group members’ privacy.  
 
 
 
V. STUDY PROCEDURES 
 
Program development 
The Phase I (described previously in protocol # 2016P000423) findings will be used to guide the 
development of a resiliency program targeted to the needs of parents of children with learning 
disabilities.  
 
Study staff will administer the consent form with participants either on phone or using the 
videoconferencing system. To facilitate proficiency with the software, participants will test the 
software with a study staff member either during consent or on a brief test call prior to the start 
of the intervention.  
 
Assessments 
Study assessments include a battery of questionnaires via REDCap and two hair cortisol sample 
collections. At baseline, participants will be administered baseline questionnaires and asked to 
provide a hair cortisol sample. At 3 months post enrollment, participants are administered a 
second set of questionnaires, and asked to complete a second hair cortisol sample. At 6 months 
post enrollment, participants are administered their final set of questionnaires.  
Hair Cortisol 
 
At enrollment (baseline) as well as at 3 months post enrollment, all participants will be 
asked to provide a hair sample to measure potential changes in cortisol levels, a method used 
successfully in stress studies. Participants will be asked to cut a small amount of hair 
(approximately 150 strands, which is about the diameter of a small paperclip) as close to the 
scalp as possible (about 3 cm), and from the back of their head. They will be asked to band or tie 
the strands near the scalp end, place on the sample in aluminum foil, and return in an envelope to 
MGH. Participants will be sent detailed sampling instructions and stamped, addressed envelopes 
to facilitate mailing. We are going to ask participants whether they regularly take  corticosteroids 
because they may interfere with the accuracy of the hair cortisol sample.  
 
The assessments are itemized below. In addition, participants will be asked to complete practice 
notes throughout their intervention.  
 
Administered at Baseline: 
3RP Battery of questionnaires 
Hair Cortisol Sample 
 
Administered 3 months post enrollment: 
3RP Battery of questionnaires 
Hair Cortisol Sample 

 
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Participant Feedback Questionnaire 
 
 
Administered during Intervention (either starting after baseline or 3 months post enrollment) 
Progress Note 
 
 
Administered 6 months post enrollment 
3RP Battery of questionnaires 
Participant Feedback Questionnaire 
 
In the SMART-3RP intervention, sessions focus on developing an understanding of stress 
physiology and the physiology of the relaxation response (RR), on developing a regular practice 
of eliciting the RR, and on learning cognitive behavioral and positive psychology/resilience 
skills. In addition to the weekly group sessions, participants will receive audio recorded guided 
meditations for independent relaxation practice. Participants are expected to practice eliciting the 
RR for approximately 20 minutes a day throughout the course of the study, using the audio 
recording provided and/or any other meditative or mind body techniques. Participants will 
complete a daily log reporting how often and by which methods they are practicing the RR. 
(Please see attached practice log).  
 
Participants randomized to Immediate or Waitlist will participate in the SMART-3RP program. 
Participants in the Immediate arm will be encouraged to practice the skills taught in the program 
during the 3 month follow up period after completion of the 8 session SMART-3RP. Participants 
in the Waitlist arm will wait for approximately 3 months before beginning the SMART-3RP.  
 
Participants in both groups will be given questionnaires at the same time points (baseline, 3 
month post enrollment, and 6 month post enrollment). Study staff will email these questionnaires 
to the participants via the REDCap system. Participants who have not responded within two 
weeks of each time point will be contacted by telephone to ensure receipt of study data.  
 
Figure 1 (below) illustrates the administration of questionnaires in both groups.  
 
Figure 1. Study Design. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Administer pre-
screen 
questionnaire 
Conduct phone 
consent 
Baseline Assessment 
(3RP Battery of 
psychological 
measures) 
Waitlist Control 
(WG)  
 
(No treatment) 
Immediate Group 
(IG)  
 
Starts SMART-
3RP (8 sessions 
via 
videoconferencing
3 mo. Post 
enrollment 
assessments 
(psychological 
measures) 
3 mo. post 
enrollment 
(psychological 
measures), n=35  
 
Starts (SMART-
3RP  
8 sessions via 
videoconferencing 
6 month post-
enrollment 
assessments  
(3RP Battery)  
End-of-treatment 
assessments (3RP 
Battery) 

 
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Remuneration 
Participants will be given a $20 gift certificate for completing 3 mo. survey and another $20 gift 
certificate for completing the 6 mo. survey assessment.  
 
VI. BIOSTATISTIC ANALYSIS 
 
We plan to conduct a pilot trial of a virtual-based SMART-3RP intervention for parents of 
children with learning disabilities. Participants in this trial will be randomized to one of two 
groups: 1) Immediate SMART-3RP intervention, or 2) Waitlist control SMART-3RP group 
(starting approximately 3 months after enrollment). 
 
The following questions will be assessed: 
 
1) Is the virtual SMART-3RP feasible and acceptable for parents who have children with 
learning disabilities? 
 
Feasibility will be assessed using attendance and homework completion (i.e. 6/8 sessions 
and homework completion).  
Acceptability will be assessed using a Participant Feedback questionnaire (See Feedback 
questionnaire attached).  
 
2) Is the virtual SMART-3RP program effective for parents of children with learning 
disabilities? 
 
a) Is there a significant difference in primary and secondary outcome measures 
between participants in the Immediate and Waitlist SMART-3RP groups at 3 mo. 
post enrollment? 
 
We will use paired samples t-tests to compare within group differences on primary and 
secondary outcome measures from 3 mo. to baseline for the Immediate and Waitlist 
Groups.  Primary outcome measures are the General Self-Efficacy Questionnaire (GSE), 
Current Experiences Scale (CES; from the Post Traumatic Growth Inventory), and the 
Visual Analogue 0-10 scales (VAS; measuring stress, distress, coping, and physical 
discomfort). Secondary outcome measures are: the Measure of Current Status-A (MOCS-
A; to assess stress reactivity), Cognitive and Affective Mindfulness Scale-Revised 
(CAMS-R; to assess growth enhancement), and the Parental Stress Scale (PSS; to assess 
parental stress). 
 
We will then use independent samples t-tests to compare the difference between the 
Immediate group’s 3 months post enrollment and baseline assessment results with the 
 
3 mo. Post 
Enrollment 
 
T2 
6 mo. Post 
Enrollment 
 
T3  
Baseline 
 
T1 

 
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difference between the waitlist group’s 3 months and baseline assessment results on 
primary and secondary outcome measures. 
 
b) Among participants randomized to both conditions, will there be improvements 
in primary and secondary outcome measures from pre-post SMART-3RP (IG: 
assessments from baseline-3 mo.; WG: from 3-6 mo.)? 
 
We will use paired samples t-tests to compare all primary and secondary assessments 
from pre-post SMART-3RP (for the IG, assessments are from baseline-3 mo.; for the 
WG, assessments are 3 mo. to 6 mo.).  
 
 
c)  Among the Immediate group only, will the changes from baseline to 3 months 
post enrollment (end of treatment) be sustained at 6 months post enrollment (3 
months post treatment)?  
 
We will use paired samples t-test to assess within-group differences in long-term 
outcomes. We will compare measures at the 6 months assessment to measures at the 3 
months assessment for the Immediate group.  
 
3) Will the virtual delivery SMART-3RP be effective in reducing participants’ stress levels, 
measured by hair cortisol? 
 
A mixed effects models approach will be used to examine differences in hair cortisol 
concentrations (HCC) at enrollment (baseline) and at 3 months post enrollment for each study 
arm. Pearson correlation or Spearman’s rank correlation will be used to examine the association 
of HCC with each of our psychological outcomes. 
 
 
VII. RISKS AND DISCOMFORTS 
 
Participants may feel uncomfortable completing various psychosocial questionnaires. As in any 
research study, there is a small risk that confidentiality may be breached; all efforts to minimize 
this risk will be taken, as outlined below. In addition, participants may find it time consuming to 
practice techniques learned in the intervention or tracking behavior such as elicitation the 
relaxation response. 
 
Hair cortisol collection: some participants may feel uncomfortable sending us a hair sample. If 
they feel this way, they will not need to. Participants can still remain in the study if they do not 
wish to send a hair cortisol sample.  
 
 
VIII. POTENTIAL BENEFITS 
 
Participants in the current study may observe a reduction in symptoms of parental stress. It is 
hoped that the intervention will result in a statistically significant reduction of symptoms across 
these domains.  

 
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The current study may provide support for parents of children with learning disabilities. This 
intervention may enhance our understanding of the role of mind-body interventions such as the 
SMART-3RP in parents of children with learning disabilities. This intervention may have 
widespread implications for types of resources available that may ultimately improve health and 
well being of parents and children with learning disabilities.  
 
 
IX. MONITORING AND QUALITY ASSURANCE 
 
All study staff will complete required Partners human subjects trainings prior to the start of study 
procedures. All interventionists and assessors will have advanced training in interviewing and 
assessment. Participants will be informed that they may refuse to answer questions that make 
them feel uncomfortable. Participants will be advised to wear headphones and sit in a quiet place 
during each virtual session. Participants will also be asked not to share the contents of the group 
with anyone else.  
 
Electronic information will be stored in REDCap (Research Electronic Data Capture), a free, 
secure, and HIPAA-compliant web-based application hosted by the Partners HealthCare 
Research Computing Enterprise Research Infrastructure & Services (ERIS) group (based at the 
PHS Needham corporate datacenter).  
 
REDCap (Research Electronic Data Capture) is a free, secure, HIPAA compliant web-based 
application hosted by the Partners HealthCare Research Computing Enterprise Research 
Infrastructure & Services (ERIS) group. The system offers easy data manipulation with audit 
trails, reports for monitoring and querying participant records, and an automated export 
mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus).  
 
Data will be stored on password protected computers that will be stored in secure locations at all 
times. Paper data files (with coded subject identification) will be stored in a locked filing cabinet. 
Only research staff will have access to these data locations.  
 
A unique anonymous identifier will be assigned to each subject; subsequently, all data collected 
will be associated exclusively with this identifier. This includes all questionnaires administered 
over the course of the study, as well as home practice logs. 
 
Data Management and Quality Control Procedures 
 
To maximize accuracy and security, all survey data will be collected and stored on REDCap. 
Research staff will ensure that proper consent has been obtained before sending the REDCap 
survey to each participant.  
 
Data and Safety Monitoring Plan 
 
Adverse Event Monitoring: Throughout the study subjects will be monitored for the occurrence 
of events defined as any undesirable experience or unanticipated risk. Lack of effect of treatment 
is not considered an event. All adverse events will be reported on an adverse event form.  

 
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The principal investigator is ultimately responsible for data and safety monitoring. If study staff 
becomes aware of any adverse events, the event will be reported immediately to the Principal 
Investigator. The Principal Investigator has the responsibility of reporting serious adverse events 
(death, life threatening illness or injury, serious injury, or permanent disability) to PHRC within 
72 hours of notification. 
 
Subject Safety 
 
In the case that an issue related to mandatory reporting or duty to warn arises, we will contact the 
Office of General Council for advice on how to proceed.  
 
X. REFERENCES 
 
                                                 
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10Miodrag N., Hodapp R.M. Chronic stress and health among parents of children with 
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