Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03658122
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2018-08-29
Brief Title:
Integrating Behavioral Treatment in Primary Care
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Integrating Behavioral Treatment in Primary Care
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor angry and irritable behaviors will refer patients to this study
At a first assessment parents will complete questionnaires about the childs 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 ie 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 childs 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
At a first assessment parents will complete questionnaires about the childs 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 ie 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 childs 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 childrens 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 clients 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 childs 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 childs 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 dyads 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 andor puppets the researcher will explain how the device listens to the childs heart and how it is attached with stickers Pediatric-grade adhesive electrodes will be applied to the childs 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 andor 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 ie f040 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 childparticipants 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 eg primary participant is mother secondary participant is father Data are stored on a secure University of California Davis Childrens 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 Childrens Hospital server
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 clients 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 childs 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 childs 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 dyads 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 andor puppets the researcher will explain how the device listens to the childs heart and how it is attached with stickers Pediatric-grade adhesive electrodes will be applied to the childs 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 andor 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 ie f040 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 childparticipants 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 eg primary participant is mother secondary participant is father Data are stored on a secure University of California Davis Childrens 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 Childrens Hospital server
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None