Integrating Behavioral Treatment in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in positive communication skills parents use during observations with children.
研究概览
简要总结
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:
- Parents' positive communication with children will improve with PC-CARE
- Parents will report less parenting stress after PC-CARE
- Parents will report fewer child behavior problems after PC-CARE
- Children will show lower stress reactivity (heart rate and blood flow) after PC-CARE
- Parents will report similar levels of child behavior problems one- and six-months after completing PC-CARE
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in positive communication skills parents use during observations with children.
时间窗: 7-16 weeks
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.
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.
时间窗: 7-16 weeks
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.
Change in children's heart rate variability (HRV) via respiratory sinus arrhythmia (RSA)
时间窗: 7-16 weeks
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.
Changes in child behavior problems on the Weekly Assessment of Child Behavior (WACB), a parent-report measure of child behavior.
时间窗: 6-8 months
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.
Changes in parenting stress on the Parenting Stress Index-Short Form, 4th Edition (PSI4-SF), a self-report measure of parenting stress.
时间窗: 7-16 weeks
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.
Change in children's heart rate variability (HRV) via Root Mean Square of the Successive Difference (RMSSD)
时间窗: 7-16 weeks
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.
次要结局
- Satisfaction with pediatrics clinic will change by Pediatrics Satisfaction Survey(7-16 weeks)
- 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.)
- Proportion of families who agree to treatment(20 months)
- Treatment retention(20 months)
- 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.)