Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective
Phase: NA
Conditions: Maternal Depression, Child Behavior Problem
Sponsor: University of California, San Francisco

A pilot trial comparing Attachment and Biobehavioral Catch-up (ABC) to 
ABC plus Depression support (ABC+D) 
Multiple Principal Investigators: Linda Pfiffner and Danielle Roubinov 
August 1, 2023
NCT05096611

 
ABC/ABC+D STUDY PROTOCOL 
Overview 
 
Depression is a prevalent and impairing mental health problem among women with young children. Empirical 
data indicate that mothers of young children experienced elevated rates of depression during the pandemic 
(Cameron et al., 2020), and ongoing societal unrest in the past several years likely contribute to ongoing 
psychological distress among caregivers. The negative influence of maternal depression on child development 
is well-established; exposure has been linked to a range of negative outcomes, including difficulties in social 
competence (Wall-Wieler et al., 2020), poorer cognitive development (Liu et al., 2020), and internalizing 
behavior problems (Roubinov et al., 2022). Moreover, the association may be bidirectional, with elevated levels 
of children’s behavior problems associated with subsequent increases in maternal depression (Roubinov et al., 
2022, 2023). To address the intertwined associations between maternal and child mental health problems, 
treatment strategies must be integrated. Yet, most extant programs are narrowly siloed to intervene on 
maternal depression or child behavior. 
 
Depression in adults in treatable and cognitive behavioral therapy (CBT) is particularly effective (Cuijpers et al., 
2013). However, CBT-based interventions are not sufficient to improve parenting problems that often co-occur 
with maternal depression (Forman et al., 2007) and they do not consistently improve children’s behavior 
problems (Galbally et al., 2017). Similarly, parenting interventions are effective for improving children’s 
behavior problems, but they do not robustly reduce parental depression (Maliken et al., 2013). To address this 
gap in the literature, the current study is conducting a pilot effectiveness trial that compares a parenting-only 
intervention (Attachment and Biobehavioral Catch-up; ABC) to an integrated parenting-maternal depression 
intervention (Attachment and Biobehavioral Catch-up plus Depression; ABC+D).  
 
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. We are examining the effectiveness of ABC versus ABC+D (i.e., ABC 
supplemented with cognitive behavioral therapy for depression) for lowering maternal depression and child 
behavior problems. 
 
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 two-arm parallel group design. Participants will be randomized to ABC or ABC+D. 
 
Study Population 
This study will include 40 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 5 or higher on the PHQ-9), subclinical or higher child behavior 
problems (defined as a score of 3 or higher on at least one domain of the Impairment Rating Scale), and 
English- or Spanish-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 primary care clinics at Benioff Children’s Hospital Oakland (BCHO), regular 
referrals made to Early Intervention Services at BCHO, community organizations serving families with young 
children, and online sources, including parenting listservs, Facebook groups, other internet-based forums, and 
information on our study website.  

 
 
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 5 or higher on the PHQ-9) and 2. Heightened 
symptoms of children’s behavior problems (a score of 3 or higher on at least one domain of the Impairment 
Rating Scale). Additional eligibility requirements for women include biological mother age 18 or older, English- 
or Spanish-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, and other aspects of the family environment.  
 
Attachment and Biobehavioral Catch-up (ABC): 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.  
 
ABC+D: ABC+D includes the same 10-session ABC home visiting program described above, and additionally 
includes supplementary CBT for depression content (i.e., +D). The primary means of delivering the +D content 
are short video modules that mothers view during and in-between ABC home visiting sessions with the parent 
coach. Development of the +D content is heavily guided by Mothers and Babies/Mamás y Bebés, an 
intervention for maternal perinatal depression that has an extensive history of RCTs and empirical support. 
ABC+D content will span 12 videos, with 1-2 video viewed weekly before, during, and/or after each of the 10 
ABC home visits and available for repeated viewings between visits. The +D content naturally extends and 
supplements the parenting-focused ABC material to address maternal depression and mood regulation. For 
example, ABC sessions that focus on responding to a child’s emotional needs with sensitivity have an 
analogous +D session to help mothers identify and respond to their own needs. Each ABC+D session teaches 
the interrelated nature of CBT for maternal depression and parenting skills training for children’s behavior 
problems (see Table 2 for a summary of ABC and ABC+D intervention modules). More specifically, Sessions 1 
and 2 of ABC+D will introduce cognitive behavioral therapy (CBT) and the relations among mood, thoughts 
and behavior. The concept and practice of behavioral activation will be reviewed in Sessions 3 and 4. In 
Sessions 5 and 6, social support and healthy interpersonal relationships are introduced as therapeutic targets 

 
and in Sessions 7 and 8, strategies to identify and challenge negative thoughts are taught. Sessions 9 and 10 
will be spent reviewing core CBT concepts and their relation to parenting, celebrating improvements, and 
planning for the future. 
 
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 and Palo Alto University. During weekly meetings with ABC intervention supervisors, the 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. During monthly supervision with +D supervisors, the parent coaches will discuss intervention 
progress and review progress toward fidelity and adherence benchmarks.  
 
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: 
• 
Patient Health Questionnaire (PHQ-9) 
• 
Interaction Rating Scale (IRS) 
• 
Self-reported status at biological mother of target child 
• 
Maternal age 
• 
Child age 
 
Pre-intervention assessment: 
• 
Patient Health Questionnaire (PHQ-9) 
• 
Early Childhood Screening Assessment (ECSA) 
• 
General Anxiety Disorder (GAD-7) 
• 
Perceived Stress Scale (PSS-4) 
• 
Behavioral Activation for Depression Scale – Short Form (BADS-SF) 
• 
Pleasant Events Schedule 
• 
Automatic Thoughts Questionnaire (ATQ) 
 
Post-intervention assessment:  
• 
Patient Health Questionnaire (PHQ-9) 
• 
Interaction Rating Scale (IRS) 
• 
Early Childhood Screening Assessment (ECSA) 
• 
General Anxiety Disorder (GAD-7) 
• 
Perceived Stress Scale (PSS-4) 
• 
Behavioral Activation for Depression Scale – Short Form (BADS-SF) 
• 
Pleasant Events Schedule 
• 
Automatic Thoughts Questionnaire (ATQ) 
• 
Video Questions  
 
Compensation 
Payments to mothers will be given in retail gift cards. The pre- and post-intervention assessment will be 
compensated $50 each.  
 
Data Collection 
Data will be collected from participants using the Redcap survey system. REDcap 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) and ABC+D intervention activities (watching brief videos) carries minimal risk for emotional 
discomfort or stress. Previous randomized controlled trials of ABC and Mothers and Babies (the intervention 
from which the +D content is derived) 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, affiliated clinics, 
or community resources.  
 
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 aims of this study are such that 
recruitment and assessment procedures may identify high-risk families, as defined by subclinical or higher 
child behavior problems 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 MPIs Dr. Roubinov and Dr. Pfiffner, California-licensed 
clinical psychologists, 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 and ABC+D interventions 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 (who developed the ABC intervention and directed previous trials) and Dr. Ricardo Muñoz and his team 
(who developed the Mothers and Babies intervention from which the +D content is derived) 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, and questionnaires. 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 and the +D content has been primarily 
designed and 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 randomized controlled trial that examines the two study arms, ABC and ABC+D, at pre-
intervention and post-intervention time points. The primary outcomes are change in maternal depressive 
symptoms (as measured by the PROMIS Depression Measure) and change in child behavior problems (as 
measured by the Early Childhood Screening Assessment).  
• 
Aim 1 and Aim 3 
o Descriptive data 
• 
Aim 2a and 2b 
o Independent t-test 
o MANCOVA - within-subjects (pre/post) and between-subjects (ABC vs. ABC+D) 
 
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.