Attachment and Biobehavioral Catch-up for Depression Intervention
Phase: NA
Conditions: Depressive Symptoms, Anxiety Symptoms
Sponsor: University of California, San Francisco

 
 
 
 
 
 
 
 
 
Attachment and Biobehavioral Catch-up for Depression 
NCT: NCT04050202 
 
 
 
 
Principal Investigator: Danielle Roubinov 
 
April 1, 2020

 
ABC STUDY PROTOCOL 
Overview 
The Attachment and Biobehavioral Catch-Up (ABC) intervention uniquely focuses on enhancing child and 
parent-child behavioral regulatory capacities in high-risk early family environments by improving parenting and 
the parent-child relationship. It has been shown to improve depression-related parenting deficiencies that are 
associated with children’s internalizing symptoms, including parental sensitivity, support, attachment quality, 
and neurobiological emotion processing. Parents in the intervention have also reported a reduction in children’s 
negative affect and behavior problems. The current study will test the preliminary effects of ABC on pre-to-post 
intervention changes in maternal depressive symptoms and children’s internalizing symptoms in a small 
sample specifically recruited on the basis of heightened symptoms in these two areas.  
  
Sources of Materials 
Data for the current study will be collected by maternal self-report and proxy-report on standardized and 
validated questionnaires. All questionnaire data will only be collected after parent consent is obtained and will 
be used for research purposes only. Pre- and post-intervention assessments of parent and child psychological 
health will be collected using written questionnaires. No identifying information will be linked to any materials or 
data collected from study participants.  
 
Study Design 
This is a single-arm, open trial of ABC. All dyads participating in the present study will receive ABC.  
 
Study Population 
This study will include a minimum of 20 mothers and their 20 biological offspring between the ages of 2 and 4 
years old. Inclusion criteria include: maternal age 18 or older, child age 2 to 4 years old, subclinical or higher 
maternal depressive symptoms (defined as a score of ≥16 on the Center for Epidemiologic Studies Depression 
Scale (CES-D), subclinical or higher child internalizing symptoms (defined as a raw score of 14 or higher on 
the internalizing subscale of the Child Behavior Checklist (CBCL), and English-speaking. Exclusion criteria 
include acute risk for suicidality (current suicidal ideation or reported suicide attempt in the previous 6 months).  
 
Recruitment 
Participants will be recruited from online sources, including parenting listservs, Facebook groups, other 
internet-based forums, and information on our study website. We will also work with colleagues in UCSF clinics 
that see women and children to receive referrals. Colleagues will be provided with study flyers and brochures 
and will also be directed to ask potential participants if they can be contacted by a member of the ABC study 
team to receive more information about the study. The study team will only reach out to potential subjects after 
such individuals have agreed to be contacted. 
 
Study Procedures 
Eligibility screening: Women will complete an online screening to determine eligibility. Women will be eligible if 
they report: 1. Heightened depressive symptoms (a score of 16 or higher on the Center for Epidemiologic 
Depression Scale (CES-D), a cut-off that suggests at least subclinical depressive symptoms; Radloff, 1977) 
and 2. Heightened symptoms of internalizing within their child (a raw score of 14 or higher on the Child 
Behavior Checklist, a cut-off that suggests at least subclinical depression/anxiety symptoms; Achenbach & 
Rescorla, 2002). Other eligibility criteria for mothers include: English-speaking and no self-reported active 
suicidality as indicated by report of current suicidal ideation or a recent suicide attempt in the previous 6 
months. Other eligibility criteria for children include age 2 to 4 years old. Those who are ineligible will be 
provided with a list of community resources.  
 
Orientation: Eligible participants will complete an orientation appointment by phone to learn more about the 
study, decide if they would like to participate, and if so, set up an appointment for the pre-intervention 
assessment.  
 
Pre-intervention assessment: Informed consent will be obtained electronically prior to the beginning of the pre-
intervention assessment. Mothers will complete structured questionnaires that assess the following: maternal 
mood and stress, child physical, socioemotional, and behavioral health, mother and child history of adversity 
exposure, marital relationship quality, and parent-child relationship quality.  

 
10-week intervention: Attachment and Biobehavioral Catch-up (ABC) was developed by Dr. Mary Dozier at the 
University of Delaware. It is an extensively researched, empirically-supported intervention that is delivered by 
“parent coaches” in one hour, once per week sessions in the home or virtually. It has been nationally and 
internationally disseminated at other academic settings and community mental health organizations in 17 
states and 7 countries. It has also been endorsed by the U.S. Department of Health and Human Services 
Home-Visiting Coalition, The California Evidence-Based Clearing House California House for Child Welfare, 
and the National Registry of Evidence-based Programs and Practices of the Substance Abuse and Mental 
Health Services Administration. The intervention includes three main targets: Improving mothers’ sensitive and 
nurturing behavior, improving mothers’ ability to detect and respond to their child’s cues, and reducing the use 
of any intrusive or negative parenting behaviors. Each of the 10 intervention sessions includes manual-guided 
discussion of the intervention content, review of between-session assignments that were given to parents, 
play-based activities that allow parents to practice each of the three aforementioned targeted behaviors with 
their child, and video feedback (parents will view clips of their own behavior from prior sessions, as well as 
standardized video examples (developed and provided by the ABC program) of target parenting behaviors). 
Throughout each of the sessions, parents coaches use “In the Moment” comments to provide feedback to 
parents regarding their behaviors that relate to the targets of the intervention. These comments bring parents’ 
attention to opportunities to provide nurturing behavior, respond to their child’s cues, etc. These comments are 
positive and supportive in nature, assisting parents in improving their interactions with their child. These 
comments are interspersed throughout the manualized content. The intervention is only provided by parent 
coaches who have been trained by ABC staff at the University of Delaware and who receive ongoing clinical 
supervision until they demonstrate certification criteria.  
 
All sessions will be recorded with audiovisual equipment for supervision purposes. Recorded sessions will also 
be uploaded via a secure server for supervision and fidelity review by researchers at the University of 
Delaware (Service Agreement and HIPAA Business Associate forms signed by the University of Delaware are 
in place). During weekly meetings with individuals at the University of Delaware, the ABC parent coaches will 
discuss intervention progress and review randomly selected 5-minute clips from one of the intervention 
sessions to ensure that In the Moment commenting is being provided accurately and at the ideal frequency.  
 
Following the onset of the COVID-19 pandemic, study procedures were adapted such that telehealth-only ABC 
sessions were conducted (no in-person contact). All intervention sessions will be conducted by HIPAA-
compliant Zoom. All other aspects of the study remain the same. 
 
Post-intervention assessment: The post-intervention assessment administers a subset of same structured 
questionnaires as the pre-intervention assessment. All questionnaires are completed online.  
 
Study Measures 
Eligibility screening: 
• 
Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977) plus one additional item to 
assess suicidality  
• 
Internalizing subscale of the Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2000)  
• 
Self-reported status as biological mother of target child  
• 
Maternal age 
• 
Child age 
 
Pre-intervention assessment: 
• 
Demographic data to characterize the sample (e.g., race, ethnicity, highest level of education attained, 
income, marital status)  
• 
Self/proxy-reported history of maternal or child treatment for mental health problems, including inpatient 
hospitalizations, residential treatment, outpatient therapy, or medication  
• 
Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977) 
• 
Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2000)   
• 
PROMIS Adult Anxiety Scale (Ader, 2007)  
• 
Perceived Stress Scale (PSS; Cohen & Williamson, 1998)  
• 
Parenting Stress Index-Short Form (PSI-SF; Abidin, 1990)  

 
• 
Adverse Childhood Events Questionnaire (ACE-10; Felitti et al., 1998) 
• 
Traumatic Life Events Questionnaire (Kubany et al., 2000) 
• 
Trauma Exposure Symptom Inventory-Parent Report Revised (TESI-PRR; Ghosh et al., 2002); 
maternal report of children's exposure to trauma with mandated reporting items removed 
• 
Parental Efficacy Scale of the Parent Locus of Control Scale (Campis, Lyman, & Prentice Dunn, 1986) 
• 
Couples Satisfaction Index (Funk & Rogge, 2007)  
• 
PROMIS Emotional Support Scale (Ader, 2007) 
• 
Global Physical Health Scale from the Health and Behavior Questionnaire (HBQ; Essex et al., 2002)  
 
Post-intervention assessment:  
• 
Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977)  
• 
Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2000) 
• 
PROMIS Adult Anxiety Scale (Ader, 2007) 
• 
Perceived Stress Scale (PSS; Cohen & Williamson, 1998)  
• 
Parenting Stress Index-Short Form (PSI-SF; Abidin, 1990)  
• 
Parental Efficacy Scale of the Parent Locus of Control Scale (Campis, Lyman, & PrenticeDunn, 1986) 
• 
Couples Satisfaction Index (Funk & Rogge, 2007) 
 
Compensation 
Payments to mothers will be given in retail gift cards. The pre-intervention assessment will be compensated 
$75 and the post-intervention assessment will be compensated $50. 
 
Data Collection 
Data will be collected from participants using the Qualtrics and Redcap survey systems. The Qualtrics system 
allows participants to read questions on the screen (or have questions read to them) and press the response 
buttons to answer. Qualtrics maintains data behind a firewall. all data is accessed only by the owner of the 
survey who must provide a unique combination of a username and password. All pieces of data are keyed to 
that identification profile and cannot be accessed by anyone else. REDcap also allows participants to read 
questions on the screen (or have questions read to them) and press the response buttons to answer. REDcap 
is hosted at the UCSF Minnesota Street data center, which is locked and guarded 24 hours per day/7 days per 
week. Entrance to the data center is only allowed by key cards that first unlock the data center and then unlock 
the security cage that protects the servers. The security of the data center is further protected by an 
Operations desk that is staffed 24 hours per day/7 days per week and by an advanced security camera 
system. REDcap servers are guarded by multiple firewall and intrusion detection systems. All electronic 
connections to the REDcap environment are encrypted. The REDcap production system is comprised of a web 
server front-end and a MySQL database server on the back-end. The web server resides in a demilitarized 
zone to ensure that survey participants are able to access REDcap surveys from any device connected to the 
internet. The back-end MySQL server resides in the protected ISU subject that kept secure by firewalls 
maintained by UCSF. The data stored in the REDcap MySQL database server can be accessed by REDcap 
end users by logging into https://REDcap.ucsf.edu and opening the REDcap projects that they have been 
granted to by owners of the projects. Only ITS and ISU administrations have authorization to access the back-
end database server directly (by logging into the virtual private network in which the database user resides 
(from https://myresearch.ucsf.edu/REDcap-faqs). All research staff will be trained in data collection and 
management procedures.  
 
Potential Risks 
Psychological and socioemotional questionnaires: Responding to the questions on these measures carries 
minimal risk for emotional discomfort or stress. Efforts will be made to place families at ease during 
questionnaire completion and procedures will be stopped upon request from parents.  
 
Although it is not anticipated that this study will cause significant psychological distress, it is likely that 
recruitment and assessment procedures will identify parents and children with distress. Protection procedures 
are outlined below in the event that significant distress is encountered during the study.  
 

 
Participation in the intervention: Engagement in the Attachment and Biobehavioral Catch-up (ABC) intervention 
activities (e.g., facilitator-directed parent-child interactions, review of videotapes of adaptive parent-child 
relationships) carries minimal risk for emotional discomfort or stress. Previous randomized controlled trials of 
the intervention have demonstrated its efficacy and safety with no adverse events reported. The intervention 
only by providers who have been trained by the intervention developer and associated staff at the University of 
Delaware. Additionally, all individuals who deliver the intervention will receive supervision and consultation 
throughout implementation of the intervention. Parents and children will be advised of their right to withdraw 
from the intervention at any time without consequence on their receipt of future healthcare services at UCSF 
Benioff Children’s Hospital or affiliated clinics.   
 
Confidentiality: Participation in research may involve a loss of privacy, however information will be handled with 
the upmost confidentiality. Consent forms and documentation of visits for intervention participation may be 
included in medical records. Thus, other UCSF healthcare staff may become aware of an individual’s study 
participation, however hospital regulations require that all healthcare providers treat medical records 
information confidentially.  
 
Inconvenience: There may be some burden associated with completing the questionnaires and attending the 
in-person visits to engage in the intervention sessions. However, families will be provided with compensation 
for travel and parking.  
 
Protection Against Risk 
Mothers and children will be told that their participation is voluntary and they can choose to withdraw from the 
study at any time without further obligation. Assurance will be given that their decision to participate, decline, or 
withdraw will not affect their current or future healthcare at UCSF Benioff Children’s Hospital or affiliated 
clinics.  
 
Discomfort associated with questionnaires: In the case of discomfort that arises from completing 
questionnaires, parents will be told that they do not have to answer any questions they do not want to answer 
and can stop at any time.  
 
Identification of parents and/or children with heightened distress: The nature of the ABC intervention and aims 
of this study are such that recruitment and assessment procedures may identify high-risk families, as defined 
by subclinical or higher child internalizing and parent depressive symptoms. Some of these families may be 
experiencing particularly significant distress requiring additional clinical services beyond that which is provided 
by the intervention. These determinations will be made by PI Dr. Roubinov, a California-licensed clinical 
psychologist (license #28292), through specific statements, interactions, situations, and endorsed survey items 
that signify risk of suicidality or high levels of distress. All study staff will be trained to probe for suicidal 
thoughts, intent, and psychotic behavior and will contact Dr. Roubinov so that appropriate steps can be taken 
to ensure the safety of the participants. It may also be the case that families present with significant distress in 
the absence of psychosis or suicidal intent, but may still benefit from more intensive clinical services, a list of 
supportive resources at UCSF and in the greater San Francisco Bay Area will be provided to all participants at 
the first intervention session regardless of their current expressions of distress.  
 
Discomfort associated with participation in the intervention: Parents and children will be provided with a 
thorough description of the ABC intervention prior to initiating treatment. In the case of significant distress 
during intervention sessions, parents and children will be told that they may stop at any time. Prior to delivering 
the intervention and throughout the study, Dr. Roubinov will consult with Dr. Mary Dozier and her staff 
(individuals who developed the intervention and directed previous trials) to minimize participant distress or 
address any significant discomfort that arises.  
 
Confidentiality: All data gathered in the present study will be handled with the upmost attention to participants’ 
confidentiality. Subjects will assigned unique, coded, confidential identifiers (code numbers), which will be used 
to label all data forms, data entries, questionnaires, and biological specimens. The key linking the subjects’ 
identity to their unique coded identifier will be encrypted and stored on secure servers at UCSF, which will only 
be able to be accessed by the study team. 
 

 
Inconvenience: All efforts will be made to minimize participant burden. Participants may be inconvenienced by 
the time spent completing questionnaires and efforts involved in engaging in the ABC intervention. Families’ 
schedules will be accommodated to the extent possible.  
 
Trained study staff will report any adverse events immediately to the PI. They will be dealt with right away, and 
if necessary, discussed with the team of mentors and consultants. If it is determined that a participant is 
experiencing high levels of distress or discomfort, any study activity will be stopped. Time will also be set aside 
during regular research meeting to discuss any small or large adverse event. If participants have any concerns 
or are experiencing distress, they will be given contact information for the PI.   
 
Inclusion of Women and Minorities 
Parents recruited into this pilot study will be limited to mothers, as ABC has been primarily designed and tested 
among mother-child dyads. Future research will consider expanding the intervention to fathers and other 
caregiver types. There are no exclusions based on race or ethnicity. Participants will be recruited from the San 
Francisco Bay Area community and efforts will be made to recruit a sample that reflects the racial and ethnic 
distribution of the geographic area. 
 
Statistical Analyses 
The current study is a small, proof-of-concept examination of ABC on maternal and child mental health in a 
sample of mothers and their offspring. Although the small sample size and absence of randomization 
precludes more complex analyses, descriptive approaches will be used to evaluate changes child and parent 
mental health symptoms from pre-intervention to post-intervention.  
 
Study Risk Assessment 
The minimal risks involved in this study may include psychological distress that can arise when individuals 
answer questions about mental health issues, however the risk is equivalent to what may be expected in 
standard medical practice or psychotherapeutic practice. 
 
Anticipated Adverse Events 
There are risks associated with physiological/psychological assessment and loss of confidentiality. None are 
expected at a frequency above 5%. 
 
Safety Monitoring 
The full study team will monitor participant symptoms. Any concerns that arise will be discussed at weekly 
meetings with the study team.  
 
Adverse Event Grading 
Severe adverse events (AE) are not expected in this study, the full adverse event grading scale will be followed 
as recommended by the UCSF IRB: 
• 
No AE or within normal limits 
• 
Mild AE, did not require treatment 
• 
Moderate AE, resolved with treatment 
• 
Severe AE, resulted in inability to carry out normal activities and required professional medical attention 
• 
Life threatening or disabling AE 
• 
Fatal AE 
 
Plan for Reporting Adverse Events 
Any AE will be immediately reported to the PI (Dr. Roubinov), handled immediately, and if necessary, 
discussed with the team of mentors. If it is determined that a participant is experiencing a high level of distress 
or discomfort, the activity will be stopped. Any small or large adverse event will also be discussed during 
weekly research meetings. Acute, adverse reactions to any procedure will be treated by physicians at UCSF. 
On-site severe AEs (grades three through five) and unexpected AEs that are related to research and result in a 
change to risk/benefit and/or require protocol and consent modifications will be reported within 10 working days 
of PI awareness. All other AEs related to research that are not serious (grades zero through two) and are 
expected will be reported annually. The only AE not related to research that would be reported within an 

 
annual report would be the death of a participant for an unrelated cause. All AE reports will be submitted to 
IRB. 
 
Safety Reviews 
The study team will set aside time during weekly scheduled meetings to review participant safety issues. The 
meeting agenda will include participant numbers and accrual rates, AEs (if any), determination of whether the 
AE was due to the study procedures, and determination of whether the AE was expected or unexpected. 
Based on these determinations, study adjustments will be made as necessary. If there are any AEs or side 
effects, Dr. Roubinov will request immediate consultation with Drs. Epel and Bush, and any other member of 
the study team, as needed. The UCSF IRB will be notified of any study changes that are deemed necessary 
via a modification and updated study consent prior to proceeding with the study.