Effects of a Behavioral Intervention With Foster Families: A Randomized Controlled Trial
Phase: NA
Conditions: Family Relationship, Sibling Relations, Behavior, Social
Sponsor: University of Arizona

 
 
 
 
 
A BEHAVIORAL INTERVENTION WITH FOSTER FAMILIES 
 
NCT Number: In progress of registering 
 
Date of Original Document: January 1, 2022  
 
STUDY PROTOCOL 
 

Purpose and Aims 
The purpose of this study is to test the effects of an easily accessible intervention that is 
unique for including both caregivers and children living in the home. Three aims will be 
conducted to: (1) establish the feasibility of the technology-based, family-centered intervention; 
(2) explore in a preliminary manner the effects of the intervention on stress and relational quality 
outcomes among family member participants; and (3) explore feasibility and preliminary 
efficacy of the intervention on diurnal salivary cortisol levels within the foster family population. 
Design  
This study will use a randomized controlled trial design. Randomization will be used to 
assign participants into the experimental or control group. Blinding of the two groups to 
participants will not be done. However, the team will blind the statistical analysis to group with 
the use of a statistician. Families assigned to the control will have the opportunity to participate 
in the intervention post- data collection and analysis and outside of the research protocol. The 
intervention was created in partnership and adapted from the Connected Family Series (CFS) by 
psychologists at the Karyn Purvis Institute of Childhood Development (KPICD). Adaptation is 
needed as the original intervention was geared toward adoptive families and excluded foster 
families. This process is currently occurring, but has not been completed. The intervention also 
needed content specific to fostering children with special needs. Stress and relational quality 
outcomes among members will be measured using the concepts of family hardiness, 
preparedness, and relationship development through a self-report questionnaire which include 
the Family Hardiness Index, the Integrating Foster Children subscale from the Casey Foster 
Applicant Inventory, and the Sibling Inventory of Behavior respectively.  
Study Timeline 

The study will span 6 months to 1 year; 1 month for recruitment and collection of 
baseline data, 2 months for the intervention, 3 months for post intervention data collection and 3 
months for data analysis in 2022. Data will be gathered during the spring and summer of 2022 
with the weight-listed control group able to participate in the intervention after data collection of 
the initial trial period. Dissemination of results is expected by 2023.  
Sample  
The study proposed here will follow rigorous guidelines to recruit and screen participants, in 
order to aid in the study’s reproducibility and appropriate application (Friedman et al., 2015). 
The defined study population is foster families with both permanent and foster children in the 
home. Inclusion criteria for the study includes the following: 1) licensed foster families, 2) must 
have at least 1 permanent child (biological or adopted) living in the home before the foster or 
newly adopted child entered the home, 3) at least one foster or foster-to-adopt child placed in the 
home, 4) all participants other than the foster or foster-to-adopt child must have English as their 
primary language or be proficient in English. Families will be recruited through professional 
organizations such as the Karyn Purvis Institute of Childhood Development (KPICD), the Utah 
Foster Care Foundation – an organization responsible for the prelicensure training and 
continuing education of foster parents in the state of Utah, as well as a foster parent support 
group social media platforms (letter of support on file with Dr. Gephart). Eligibility criteria 
ensures that sibling interactions and how they affect placement stability will be captured.  
Sample Size Justification  
 
The total sample size for the study (N=130) of families was estimated for 80% power for 
t-test and ANOVAS, α<.05  using G*Power software. Although the exact effect size of the 
intervention is unknown, we used results from the randomized control trial by Schoemaker et al. 

(2020) in which a video intervention to improve parenting among foster families was used and 
their effect size of 0.34 for differences of the intervention on parenting sensitivity measures 
using the adapted Ainsworth scales for sensitivity and non-interference. Consistent with 
Shoemaker et al., a similar sample size was found to be sufficient to detect significant results for 
the original Connected Family Series. Collection of salivary cortisol to achieve exploratory aim 3 
will be done with a smaller sample size of 40, consistent with previous similar feasibility studies 
for hypothalamic–pituitary–adrenal (HPA)-axis function (Pace et al., 2021).  
Participant Recruitment  
Once a family is recruited, they will be connected (within 1 week) with a study team 
member and screened for inclusion and exclusion criteria via zoom. If appropriate, the family 
will be enrolled in the study. Information will be given about the study and informed consent 
will be collected. An independent statistical team will ensure stratified random assignment to 
study groups.  
Human Subjects Protection  
 
Foster families, including parents, biological children, and foster children in the home 
(age 6 to 18), recruited through a licensing agency (Foster Care Foundation) will take part in an 
educational training and support network designed to help participants to prepare and thrive 
while caring for children in the foster care system. Subjects will come in contact with a Trust-
Based Relational Intervention (TBRI) trainer and therapist virtually on-line (K. B. Purvis et al., 
2013). TBRI education is the current standard for foster parent training for families accepting 
level III placements. The pediatric population is needed because both the caregivers and the 
children in the home have an impact on the stability of the placement.  

 
A special and vulnerable population (children) will be involved in order to conduct 
research that is intended to impact to improve participant lives and by extension, more 
vulnerable children (i.e., those in foster care) with current great need relative to risks that are 
comparably minimal. Online platforms, particularly those that are intended to facilitate effective 
parenting of children with special needs, hold promise for strengthening current training 
programs (Kaasbøll et al., 2019). Including children is likely to increase the success of parental 
trainings. Without studying the family as a whole, we lose the family-centered potential to 
improve long-term outcomes for foster children. We also are likely to improve the functioning 
and mental health of the children who participate in the training/intervention. The proposed 
research uses a stratified randomization design for children with severe behavioral and 
developmental disabilities, to ensure that the research is reproducible. The control group 
(receiving no intervention) will be given the opportunity to participant in the intervention after 
the initial trial. 
Potential Risks  
Participants will not be put at financial or physical risk during any phase of the proposed 
research. Psychological and social risks will be addressed through the use of confidential 
psychological support and referral to treatment or therapy as needed. Because all participants 
will be licensed foster families, cost of therapy will be covered under the current program 
already available to foster families.  Participants will continue to receive the standard of care or 
support available in addition to the intervention. Due to the sensitive information that may arise 
during the study, legal risks and obligations will be monitored by a data and safety monitoring 
board, compromised of individuals not directly tied to the study (see below). A report will be 
given by the PI on a monthly basis to the board. A case worker positioned within the governing 

agency will be available via cell phone 24/7 to the PI. If a researcher or therapist 
encounters a situation that may appear to be a safety or legal risk, they will have 24 hours 
to notify the PI and caseworker.  
Adequacy of Protection Against Risks 
Recruitment and Informed Consent  
Families will be recruited through social media platforms. The study coordinator 
will screen interested families. For participants who fit the inclusion criteria, the study 
coordinator will explain the study and expectations and provide the paperwork for 
informed consent. Signed consent forms will be locked in a cabinet in the Office of 
Nursing Research at the University of Arizona.  
Protection Against Risk 
 
The identity of participants will remain anonymous and confidential. The following 
safeguards will be put in place: a) unique identification numbers will be used for computerized 
data entry, b) data will not be released except in aggregate form, c) agency and names or other 
identifying variables will be absent from written communication or presentations.  
Potential Benefits of the Proposed Research to Humans Subject and Others  
The average participant will have a 50% chance of being randomized into the 
intervention group, but all participants will have the opportunity to eventually participate 
in the intervention if they so choose. The intervention is aimed at improving family 
relationships and will provide additional community resources. Foster children will 
benefit from having foster parents and siblings that better understand how to connect and 
develop positive relationships with children who may have a background of trauma.  
Importance of the Knowledge to be Gained 

Findings from this trial will be used to improve the placement stability and health of over 
600,000 children in the foster care system every year. Results are expected to help improve the 
resilience of foster families through education and preparation.  
Data and Safety Monitoring  
The PI will be responsible for reviewing the feedback from the modules. Each week, a 
review meeting will be held with the PI and the trained therapist to review any concerns or needs 
of the participants. The Institutional Review Board (IRB) at the University of Arizona will be 
used for approval and oversight of the trial. The independent safety auditor will conduct reviews 
of patient responses and reaction to the intervention. A Data and Safety Monitoring Board 
(DSMB) will oversee coordination and risks across the different settings.  This committee will 
consist of 4 individuals (the PI, the KPICD licensed therapist, and two dissertation committee 
members), who will meet on a quarterly basis to review and address any perceived or potential 
risks as the study progresses.   
ClinicalTrials.gov Requirements 
This study does not include trials of drugs or biologics nor does it include a trial for a device. 
However, it will be registered at clinicaltrials.gov. 
Instrumentation  
Sources of Materials 
 
Research material will be obtained in the form of online surveys and point-of-care saliva 
collection. Surveys and saliva will be collected before the intervention (T1) and after the 
intervention (T2). Additional collection at 1-month post intervention (T3) will occur. Surveys 
include the Sibling Inventory of Behavior (SIB), the Family Hardiness Index (FHI), and a 
modified version of the Casey Foster Applicant Inventory-Applicant Version. Data gathered will 

be coded using a unique identifier for each participant. The name and identifying number will be 
locked separately from the data with access only available to the primary investigator.  Saliva 
specimens will be collected by the participants with only the identifying number on the tube.  
Pre-Intervention Assessment  
 
Participants screened and deemed to fit inclusion and not exclusion criteria will fill out a 
demographic survey and intent to offer permanency. Families will also be asked their willingness 
to participate in salivary cortisol collection. Caregivers will complete the three-pronged battery 
of assessments containing a total of 52 questions with an expected time to complete of 15 to 20 
minutes for all questionnaires, which will be formatted into one questionnaire for participants. 
The three questionnaires include the Family Hardiness Index, the Sibling Inventory of Behavior, 
and the Modified Casey Applicant Inventory.  
 
Hardiness - Family Hardiness Index (FHI) 
Measurements for family hardiness will be done using the Family Hardiness 
Index (FHI). The FHI instrument is a 20-item Likert-type scale with a 4-point response 
scale ranging from false to true about the family situation (McCubbin et al., 1987). 
Higher scores indicate higher family hardiness. Validity and reliability have been 
established through positive correlations with family function measures, with an 
Cronbach’s alpha coefficient of .82 with test-retest reliability of .86 (McCubin et al., 
1996). Studies have employed the FHI to accurately indicate a hardiness levels within 
foster families and those raising children with special needs (Hendrix & Ford, 2003; 
Roberts et al., 2017). See Appendix D: Family Hardiness Index.  
Relationship Development - Sibling Inventory of Behavior (SIB)  

The Sibling Inventory of Behavior (SIB) was developed to assess sibling relationships 
between a typically developing sibling and a child with a disability using a 28-item questionnaire 
(Schaefer, 1981) and will be used here to assess relationship development. The measure assesses 
four aspects of sibling relationships: kindness (nine items), avoidance (six items), involvement 
(seven items), and empathy (six items). Validity of the SIB scales was demonstrated using 
correlational and observational data with Cronbach alphas ranging from .64 to .81 for each item, 
indicating that these items are closely related and thus internally consistent (Volling & Blandon, 
2003). See Appendix E: Sibling Inventory of Behavior.   
Family Preparedness - Modified Casey Foster Applicant Inventory  
A modified version of the Casey Foster Applicant Inventory-Applicant Version will be 
used to assess family preparedness, which is a psychometric self-report tool used to assess the 
potential readiness and ability to foster parent successfully (Buehler et al., 2006). Data from 
previous studies involving foster parents have shown internal consistency and reliability (ranging 
from 0.64 to 0.96) (Orme et al., 2007). The Integrating Foster Children subscale includes ability 
to integrate a foster child into a foster family with birth or adopted children (Orme et al., 2006). 
Questions are based on a Likert scale from 1 (strongly disagree) to 4 (strongly agree). Example 
statements include, “My children want to have a foster brother or sister” and “My children are 
able to deal with a foster child with serious problems.” See Appendix F: Casey Foster Applicant 
Inventory Questionnaire.  
Exploratory Objective Biological Measure of Stress – Salivary Cortisol 
To measure the exploratory aim for objectively measuring an indicator of family stress 
and HPA axis function, the psychobiological maker of diurnal salivary cortisol will be tested. 
Concentration of cortisol in saliva over the course of the day is normally high in the morning, 

peaks 30-60 minutes after wakening (cortisol awakening response/CAR), and is low at night, 
indicating healthy hypothalamic-pituitary adrenal (HPA) axis function (Adam et al., 2017). 
Relative disruptions in diurnal cortisol rhythm (e.g., high bedtime levels, a flatter diurnal slope 
from waking to bedtime, high overall concentration across the day) have been associated with 
self-reported stress, as well as other aspects of psychological well-being (e.g., depression)(Adam 
et al., 2017; Juarez Garcia et al., 2016). This study will employ the same methods and analysis as 
employed by Pace et al. (2021) and was done with permission.  
Salivary Cortisol  
Collection of saliva will include two family members: the primary caregiver and the 
permanent sibling that is closest in age to the foster child. If two permanent children are the same 
age difference away from the foster child, the permanent sibling with who the foster child 
interacts with most will be selected. Consent and assent forms will be signed by parent and child. 
Saliva will be gathered for three consecutive days before the intervention (days 1, 2, and 3) and 
after the intervention (days 31, 32, and 33); each sampling day, participants will provide a 
waking, 30 min after waking, and bedtime sample. A two-week window for saliva collection will 
be allowed depending on when the participating family completes the intervention. Participants 
passively drool through a straw into a 2mL polypropylene tube and labeled each tube with the 
time and date. Participants will be instructed not to eat, drink, or brush their teeth 30 minutes 
before each sample, and to keep completed samples in the refrigerator throughout the study 
period. Participants will ship saliva samples to the lab and samples will be then stored at -20°C. 
Saliva samples will be batch assayed in duplicate according to manufacturer instructions for 
cortisol concentrations using an enzyme immunoassay (EIA) kit (Salimetrics, State College, PA). 
Inter- and intra-assay coefficients of variability in previous studies by the Pace research team 

were 8.16% and 7.74%, respectively. In line with prior work (Zeiders et al., 2014), the following 
cortisol parameters will be assessed: waking level (Sample 1), bedtime level (Sample 3), the 
CAR (the difference between Sample 2 – Sample 1), the diurnal slope (the difference between 
Sample 3 - Sample 1), and the area under the curve (AUC) to assess total cortisol output across 
the day. AUC will be calculated using the trapezoidal method.