Integrating Behavioral Treatment in Primary Care

The current study proposes offering Parent-Child Care (PC-CARE; Timmer et al., 2018), a brief
(6-session) behavioral intervention, to children from 2-10 years of age within the primary
care building with the goal of improving parent-child relationships, decreasing child
disruptive behaviors, and improving parents' knowledge and use of effective parenting
strategies, as well as better integrating behavioral health treatments within the primary
care setting. To assess the acceptability of integrating these services within primary care,
the investigators will examine the proportion of families who participate in treatment out of
the total number referred, and the proportion of families completing treatment. To determine
the efficacy of PC-CARE in meeting treatment goals, this study uses a randomized control
trial study design with a PC-CARE treatment group and a waitlist control group. To better
understand the effects of the intervention and potential mechanisms related to improvements
in children's disruptive behaviors, the study uses multiple assessment modalities, including
parent-report questionnaires, behavioral observations, and physiological data during
parent-child interactions. The investigators will additionally assess maintenance of
treatment gains by conducting follow-up assessments at one- and six-months post-treatment.

The following hypotheses will be tested:

Hypothesis 1: Increase acceptability of integrative primary care.

A. The proportion of families who agree to treatment with be at least 75% of those who are
referred, and the retention rate for completing PC-CARE will be at least 90%.

B. Caregiver-child dyads that receive PC-CARE when compared to the waitlist control group
will report higher levels of satisfaction with their primary care provider and medical office
(as measured by the Pediatrics Satisfaction Survey).

Hypothesis 2: Improve pediatricians' ability to detect child mental health service needs.

A: The total number of referrals per month will increase over the two-year grant period;
demonstrating pediatricians' enhanced ability to recognize the need for behavioral services.

Hypothesis 3: Improve parenting skills

A. Caregiver-child dyads that receive PC-CARE when compared to the waitlist control group
will show significant increases in positive communication skills (as measured by PC-CARE
observational coding) from pre to post treatment.

B. Caregivers that receive PC-CARE will report higher levels of parenting competence (as
measured by the Brief Parenting Stress Index [PSI4-SF]) compared to the waitlist control
group

Hypothesis 4: Improve child behavioral problems and self-regulation

A. PC-CARE trained parents, compared to the waitlist control group, will report significant
decreases in levels of child behavior problems (as measured by the Weekly Assessment of Child
Behavior [WACB] and Behavior Assessment Schedule for Children, 3rd Edition [BASC-3]) from pre
to post treatment.

B. For children with trauma histories, those who complete PC-CARE with their caregivers,
compared to the waitlist control group, will show improvements in trauma symptoms from pre-
to post-intervention (as measured by the Early Childhood Traumatic Stress Screen [ECTSS] or
the Child and Adolescent Trauma Screener [CATS]).

C. After completing PC-CARE with their caregivers, children will show lower levels of
autonomic stress reactivity compared to their pre-treatment levels and compared to the
waitlist control group (as measured using the Biopac MP150 acquisition unit).

Hypothesis 5: Maintain positive treatment effects

A. Caregivers will report similar levels of child behavior problems (as measured by the WACB)
one and six months after treatment as they did at the post-treatment assessment, indicating
the treatment gains were maintained.

Before starting recruitment, the investigators will meet with physicians at the pediatrics
clinic to discuss the value of integrated primary care, explain the PC-CARE program, and
discuss observed behaviors or parent concerns that would warrant referral to the program, and
teach them how to make referrals. The investigators will provide the primary care physician
(PCP) with information about our research study and intervention and will educate them on
appropriate clients. When a PCP feels a child would meet criteria for this study, the PCP
will provide the caregiver with the recruitment flier and ask for consent to provide the
client's information to the research team.

Caregivers that consent to participate in this research study will complete the pre-treatment
assessment with their children and then be placed in either the waitlist control group or in
the treatment group. Those placed in the treatment group will actively participate in 6
weekly sessions of PC-CARE treatment and respond to a one-month and six month follow-up phone
call to provide support and check up on the child's functioning. Caregivers placed in the
waitlist control group will participate in the pre-treatment assessment and after
approximately two months will be contacted to complete another pre-treatment assessment and
to participate in 6 weekly sessions of PC-CARE treatment and afterward will respond to a
one-month and six month follow up phone call to provide support and check up on the child's
functioning.

For the pre-treatment assessment, parents will complete various questionnaires related to
child behavior, parenting stress, and satisfaction with the pediatrics clinic. Parents and
children will participate in a video-recorded 12-minute observational assessment of
parent-child dyads as they play together in three semi-structured play situations that are
analogs of typical parent-child interactions. Each of the 4-minute scenarios will be coded in
the moment by the therapist, and later by a research assistant who is blind to the dyad's
treatment group. While the therapist introduces PC-CARE to the caregiver, a trained
researcher will work with the child to acquire cardiac physiological signals. Using a
combination of age-appropriate explanations, books, and/or puppets, the researcher will
explain how the device listens to the child's heart and how it is attached with stickers.
Pediatric-grade adhesive electrodes will be applied to the child's torso and connected to an
amplifier to record the signals using flexible wires. Physiological signals will be collected
using a Biopac MP150 acquisition unit. The ECG100C amplifier will be used to collect
electrocardiogram data. Children will then watch a 2-min neutral film clip in order to
collect a resting measure of autonomic activity. Following this, they will complete two
challenging tasks. First, children will have 3-minutes to work on a difficult puzzle on their
own. Second, children will spend 3-minutes working on a difficult tangram puzzle with their
caregivers. The difficulty of the materials will be age-adjusted. At the end of the
assessment, the therapist will provide information about PC-CARE, identify treatment goals,
and indicate whether the family has been assigned to waitlist control group or the treatment
group.

During the treatment phase of this study, parents and children will attend weekly one-hour
PC-CARE sessions for six weeks. At the beginning of these sessions, parents will complete a
brief measure of child behaviors for the week. Then parents, children, and therapist will
discuss behaviors from the week and identify behavioral goals for the session. The therapist
will then teach new positive communication, self-regulation, and/or behavior management
strategies to the parent and child together. The parent-child dyad will then be observed from
behind a two-way mirror while they play for four minutes. The therapist will then coach the
parent to use the newly learned skills by speaking to the parent via an ear-piece from behind
the mirror. The session ends with the therapist reviewing progress with the parent and child
and identifying a plan for incorporating new skills into the home environment. Parents and
children are also assigned 'Daily CARE' to spend five minutes playing together daily and to
use the new skills throughout the day.

A power analysis showed that in order to detect a large-sized effect (i.e., f=0.40,
eta-squared = .138) with a power of 80, which is appropriate for a wait-list control design,
this study would need a sample size of at least 25 families per group (Cohen, 1988). With an
estimated attrition rate of 10%, the investigators plan to recruit 28 dyads for each group,
comparison and control (Total N = 56) over the two-year study period. Information will be
entered and stored in a Microsoft Access database, designed to score standardized measures
and store all information relevant for data analysis. Standardized measures will be
double-entered to ensure accuracy of scoring; reliability estimates will be assessed for all
information that is "judged" or "coded." Each dyad (parent and child) will be identified by a
unique ID composed of the child/participant's assigned subject identification (ID), the time
in treatment (should the child receive PC-CARE more than once), and an indicator of which
caregiver at any particular time in treatment is the participant in question (e.g., primary
participant is mother, secondary participant is father). Data are stored on a secure
University of California Davis Children's Hospital server, which is password-protected and
backed up daily. Physiological data will be acquired using a University of California Davis
issued laptop computer and identified only with the unique ID. Raw data files will be
uploaded to a secure University of California Davis Children's Hospital server.

Inclusion Criteria:

- Caregiver-child dyads in which the child has been in the custody or care of the
caregiver for at least one month.

- Children at least 2 years old and no older than 11 years.

- Caregivers participating in this study must complete all measures assessing the
child's functioning pre-intervention and the behavioral observation.

- Caregiver-child dyads participating in this study must agree to be video-taped.

- The caregiver must be able to read at a 4th grade reading level.

Exclusion Criteria:

- Caregiver-child dyads will be excluded from the study if the child has been in the
custody or care of the caregiver less than a month.

- Caregiver-child dyads will be excluded from the study if there were any missing
pre-treatment assessment measures.

- Caregiver-child dyads will be excluded from the study if the dyad did not consent to
be video-taped.

- Caregiver-child dyads will be excluded from the study if the caregiver is unable to
receive treatment in English.