Integrating Behavioral Treatment in Primary Care
Condition: Problem;Behaviour;Child; Parent-Child Relations
Study type: Interventional

Summary: 
      This study seeks to assess the usefulness of Parent-Child Care (PC-CARE), a brief behavioral
      intervention for children with difficult behaviors. It will test whether PC-CARE can help
      families who talk to their pediatricians about behavior problems by improving parent-child
      relationships, decreasing disruptive behaviors, and improving parents' knowledge and use of
      effective parenting strategies. Pediatricians who observe or are told their 2-10-year-old
      patients have difficult behaviors, such as aggression, disobedience, tantrums, trouble
      focusing, and/or angry and irritable behaviors, will refer patients to this study.

      At a first assessment, parents will complete questionnaires about the child's behaviors,
      parents and children will participate in a 12-minute play observation, and children will have
      their heart rate and blood flow measured during a 6-minute play observation. After this
      assessment, families will be randomly assigned either to begin PC-CARE right away or to wait
      about two months to begin PC-CARE.

      Those who begin right away will attend weekly one-hour appointments for six weeks. During
      appointments, parents and children report on difficult behaviors from the week, learn new
      positive communication, regulation, and behavior management skills, are observed during a
      4-minute play observation, are coached to use the skills (i.e., have the therapist tell the
      parent how to use skills while interacting with the child), and discuss how to incorporate
      these skills at home. Parents and children are also asked to play together for five minutes
      daily at home. At the end of the six weeks, parents and children will complete the same
      assessments they did at the beginning.

      Those who wait to begin PC-CARE will be asked to complete the same questionnaires and
      observations again before beginning PC-CARE. They will then receive the same treatment as
      families who began PC-CARE right away. All families will be called one- and six- months after
      ending PC-CARE to complete a brief questionnaire about the child's behaviors.

      Main study hypotheses include:

        1. Parents' positive communication with children will improve with PC-CARE

        2. Parents will report less parenting stress after PC-CARE

        3. Parents will report fewer child behavior problems after PC-CARE

        4. Children will show lower stress reactivity (heart rate and blood flow) after PC-CARE

        5. Parents will report similar levels of child behavior problems one- and six-months after
           completing PC-CARE
    

Detailed description: 
      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.
    

Intervention name(s): Parent-Child Care
Intervention type(s): Behavioral
Intervention description(s): Parent-Child Care (PC-CARE) is a 6-week parenting intervention for children aged 1-10 years and their caregivers. This behavioral intervention involves weekly behavioral assessments, teaching of new skills, in-the-moment practice using the new skills, and discussion of how to incorporate skills at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized controlled trial with waitlist control. The waitlist control group will receive the study treatment after a two-month wait.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parent-Child Care; Parent-Child Relationship; Disruptive Behavior; Brief Intervention