Integrating Behavioral Treatment in Primary Care

NCT03658122 | Completed

• 1 other identifier: 1301710
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 1.Parents' positive communication with children will improve with PC-CARE
2. 2.Parents will report less parenting stress after PC-CARE
3. 3.Parents will report fewer child behavior problems after PC-CARE
4. 4.Children will show lower stress reactivity (heart rate and blood flow) after PC-CARE
5. 5.Parents will report similar levels of child behavior problems one- and six-months after completing PC-CARE

Conditions

Problem;Behaviour;Child; Parent-Child Relations

Keywords

Parent-Child Care; Parent-Child Relationship; Disruptive Behavior; Brief Intervention

Outcome Measures

Primary Outcomes (6)

• Change in positive communication skills parents use during observations with children.

  Parents' use of positive communication (PRIDE) skills and statements to avoid (Avoid), as coded with the PC-CARE Observational Coding, will be coded during observations with the child at pre-treatment, each weekly session, and post-treatment.

  7-16 weeks

• Changes in child behavior problems and improved adaptive functioning on the Behavior Assessment Schedule for Children, 3rd Edition (BASC-3), a parent-reported measure of child behavior.

  BASC-3 composite scales = Externalizing, Internalizing, Behavioral Symptoms, Adaptive Skills. Subscales = Hyperactivity, Aggression, Conduct Problems, Anxiety, Depression, Somatization, Atypicality, Withdrawal, Attention Problems, Adaptability, Social Skills, Leadership, Activities of Daily Living, Functional Communication. Scores are converted to T-scores. T-scores are standardized, with a mean of 50 and standard deviation of 10. For the behavior problem scales, scores above 60 are considered problematic; for the adaptive scales, scores below 40 are considered problematic.

  7-16 weeks

• Changes in child behavior problems on the Weekly Assessment of Child Behavior (WACB), a parent-report measure of child behavior.

  WACB is a 9-item measure of child behavior plus one item regarding parenting stress. Frequency of behaviors (1=never to 7=almost always) and whether behaviors need to change (1=yes, 0=no) are recorded at pre-treatment, each weekly session, post-treatment, one month post-treatment, and six months post-treatment. The parenting stress severity score has a range of 1-7, with higher number indicating more stress. The parenting stress need to change score is either 0 or 1, with 1 indicating the stress level needs to change. The severity of behavior problems is a total score (sum of the 9 behavior problem frequency scales) with a range of 9-63. The behavior problem need to change score is a total score, with a range of 0-9. For both scales, higher scores indicate more problems.

  6-8 months

• Changes in parenting stress on the Parenting Stress Index-Short Form, 4th Edition (PSI4-SF), a self-report measure of parenting stress.

  PSI4-SF yields four scales: Parent-Child Dysfunctional Relationship, Difficult Child, Parental Distress, and Total Stress. T-scores are computed for each scale. T-scores are standardized scores, with a mean of 50 and standard deviation of 10. Scores above 60 are considered problematic. Parents complete PSI4-SF at pre-treatment and post-treatment.

  7-16 weeks

• Change in children's heart rate variability (HRV) via respiratory sinus arrhythmia (RSA)

  Children are connected via sticky electrodes to an ECG100C amplifier to measure electrocardiogram activity (ECG) in response to difficult tasks. RSA, a measure of HRV, is computed from the ECG signal using computer software and the Biopac MP150. RSA is a frequency measure, with a unit of natural log of ms squared (ln ms\^2). The RSA indexes variability in heart rate that occurs in a high frequency range, the range of respiration. This variability is attributed to parasympathetic influence on the heart. RSA will be measured at pre-treatment and post-treatment.

  7-16 weeks

• Change in children's heart rate variability (HRV) via Root Mean Square of the Successive Difference (RMSSD)

  Children are connected via sticky electrodes to an ECG100C amplifier to measure electrocardiogram activity (ECG) in response to difficult tasks. RMSSD, a measure of HRV, is computed from the ECG signal using computer software and the Biopac MP150. RMSSD looks at changes in the time between heartbeats. The RMSSD indexes variability in heart rate that occurs in a high frequency range, the range of respiration. This variability is attributed to parasympathetic influence on the heart. RMSSD will be measured at pre-treatment and post-treatment.

  7-16 weeks

Secondary Outcomes (5)

• Proportion of families who agree to treatment

  20 months

• Treatment retention

  20 months

• Reductions in child trauma symptoms by the Early Childhood Traumatic Stress Screen (ECTSS), a parent-report measure of children's trauma exposure and trauma-related symptoms.

  7-16 weeks.

• Changes in child trauma symptoms by Child and Adolescent Trauma Screen (CATS), a parent-report measure of trauma experiences and trauma-related symptoms

  7-16 weeks.

• Satisfaction with pediatrics clinic will change by Pediatrics Satisfaction Survey

  7-16 weeks

Study Arms (2)

Parent-Child Care Treatment

EXPERIMENTAL

Participants receive PC-CARE treatment immediately following the pre-treatment assessment.

Behavioral: Parent-Child Care

Waitlist Control then Parent-Child Care

OTHER

Participants wait approximately 2 months with no intervention before completing another pre-treatment assessment (post-waitlist assessment) and receiving PC-CARE treatment.

Behavioral: Parent-Child Care

Interventions

Parent-Child Care BEHAVIORAL

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.

Parent-Child Care Treatment; Waitlist Control then Parent-Child Care

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Children's Hospital

Sacramento, California, 95820, United States

Location

Related Publications (2)

• Timmer SG, Hawk B, Forte LA, Boys DK, Urquiza AJ. An Open Trial of Parent-Child Care (PC-CARE)-A 6-Week Dyadic Parenting Intervention for Children with Externalizing Behavior Problems. Child Psychiatry Hum Dev. 2019 Feb;50(1):1-12. doi: 10.1007/s10578-018-0814-8.

  PMID: 29855819 BACKGROUND

• Cohen, J. (1988). Statistical power analysis for the behavioral sciences, 2nd Ed. Lawrence Erlbaum, Hillsdale, NJ

  BACKGROUND

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Brandi N Hawk, Ph.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial with waitlist control. The waitlist control group will receive the study treatment after a two-month wait.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Study Start: September 18, 2018
• Primary Completion: October 1, 2020
• Study Completion: March 30, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)