Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21HD093944 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Michigan | OTHER |
Not provided
Not provided
Not provided
Not provided
Childhood obesity is a formidable public health issue in the United States, disproportionately affecting children from lower socioeconomic status households. Onset of obesity predicts cardiometabolic risks and other health problems in adolescence and into adulthood; thus, effective and early prevention is critical. Healthy parenting may play a pivotal role in preventing early childhood obesity. Warm, responsive, and consistent parenting is associated with the development of child self-regulation as well as healthy eating and physical activity practices, and thus may be protective against obesity risk. Targeting the parent-child relationship may be especially important when facilitating behavior change in parents who have ongoing stressors (e.g., low-income families). The proposed study aims to test an adaptation of Parent-Child Interaction Therapy (PCIT), an innovative parent management program that improves the parent-child relationship and enhances general parenting skills through the use of therapeutic in vivo coaching. Our adapted version, PCIT-Health, is a selective-prevention intervention that includes content specific to improving parent-child interactions and parenting in obesity-salient contexts, such as mealtime and child screen time. This project will elucidate novel approaches to, and novel targets of, early childhood obesity prevention and will provide data critical to test PCIT-Health in a large-scale randomized controlled trial. Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control in order to accomplish the following aims: AIM 1: To assess the acceptability and feasibility of the PCIT-Health delivery and assessment methods in low-income parents of overweight young children ages 3 to 6 years. AIM 2: To test the preliminary efficacy and estimate the effect size of PCIT-Health on changes in child BMI z-score (primary outcome) from baseline to (1) intervention completion and (2) 6-month post-intervention. AIM 3: To explore the effect of PCIT-Health on the following secondary outcomes: (1) parent-child relationship quality, (2) parent behavior management skills, (3) child self-regulation, (4) child eating behaviors, (5) child physical activity, and (6) child screen media use.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCIT-Health | Experimental | Participants assigned to the PCIT-Health arm will receive the intervention. |
|
| Wait list control | No Intervention | Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCIT-Health | Behavioral | PCIT-Health (also known as Parents Active in Their Children's Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Body Mass Index (BMI) Percentile | Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure | Pre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention) |
| Change in Child Body Mass Index (BMI) Z-score | Change in child BMI z-score will be calculated using standardized anthropometric measurement (height and weight) procedure. The z-score is a standard deviation away from the mean, based on the CDC growth charts. Higher z-scores indicate greater weight status. A Z-score of 0 equals the population mean, based on age and sex. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Child Self-regulation (Parent Report) | Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4 | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Child Disruptive Behaviors (Parent Report) | Eyberg Child Behavior Inventory (ECBI); intensity t-score. Higher t-scores indicate poorer outcomes (i.e., greater intensity of behavior problems). T-scores have a mean of 50 (SD = 10). T-scores of 60 or higher indicate clinical significance. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah Domoff, PhD | Central Michigan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Children, Families, and Communities | Mount Pleasant | Michigan | 48858 | United States |
After enrollment (providing consent), but before assignment, two families declined to continue participating in the study. (n = 4).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PCIT-Health | Participants assigned to the PCIT-Health arm will receive the intervention. PCIT-Health: PCIT-Health (also known as Parents Active in Their Children's Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time). Due to the pandemic, telehealth PCIT-Health was provided to most of the participants. |
| FG001 | Wait List Control | Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PCIT-Health | Participants assigned to the PCIT-Health arm will receive the intervention. PCIT-Health: PCIT-Health (also known as Parents Active in Their Children's Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time). Due to the pandemic, telehealth PCIT-Health was provided to most of the participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Separated by child and caregiver data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Child Body Mass Index (BMI) Percentile | Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure | For Time 2, n = 11 for PCIT-health and n = 7 for control. For Time 3, n = 9 for PCIT-health and n = 6 for control. | Posted | Mean | Standard Error | percentile | Pre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention) |
|
During of the study (approximately 10 months)
Weekly check-ins with participants about well-being for families enrolled in the intervention; bimonthly check-ins between baseline and 6 month follow-up for enrolled families. Did not explicitly ask about adverse events, but inquired as to family and child well-being.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCIT-Health | Participants assigned to the PCIT-Health arm will receive the intervention. PCIT-Health: PCIT-Health (also known as Parents Active in Their Children's Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time). |
Not provided
Not provided
The COVID-19 pandemic necessitated changes to our methodology. We changed our intervention into a telehealth format delivered through synchronous video conferencing and other remote distancing strategies. We had to temporarily suspend in-person data collection for participants in the early part of the pandemic, until distancing guidelines could be adhered to safely with personal protective equipment in our clinic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Domoff, PhD | Central Michigan University | 989-774-6461 | domof1se@cmich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2023 | Apr 5, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2019 | Feb 9, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control.
Not provided
Not provided
Behavioral observation coders are masked.
|
|
| Child Screen Time |
Parent report of weekly amount of time child spends viewing/using screen media. Scores range from 0-168, with total scores reflecting sum of daily screen time across multiple types of screen media. Higher scores = more screen time. |
| Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Child Physical Activity | Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA) | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Child Sleep (Parent Report) | Measured by parent report of bedtime, wake time, and naps. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Child Sleep (Via Actigraphy) | Measured by Actigraph accelerometer. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Child Problematic Media Use | Measured by the parent-report via Problematic Media Use Measure (Domoff et al., 2019). Higher scores = greater problematic media use. Total scores = mean of items; Min = 1 to Max = 5. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Parent-child Relationship Quality (Observed) | Dyadic Parent-Child Interaction Coding System-IV (DPICS-IV) will be used. The DPICS provides a reliable measure of parent-child relationship quality (e.g., parents' child-centered skills, parent and child positive and negative physical and verbal interactions) and parent behavior management skills (e.g., use of contingent reinforcement, effective discipline, child compliance). This outcome reflects behavioral observation of parents' child-centered skills ("DO" skills) during child led play. This is a count variable that can range from 0 displayed skills (min) with no determined maximum. Higher numbers = more skills (better outcome). | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Parent-child Relationship Quality (Parent Report) | Scores on the Parent-child Dysfunctional Interaction (PCDI) subscale of the Parenting Stress Index will be used as the parent-report of parent-child relationship quality. Values range from 12 to 60, with higher scores indicating greater dysfunction in (poorer quality of) the parent-child relationship. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Pressure to Eat (Parent-report) | Scores on the Child Feeding Questionnaire (CFQ)- Pressure to Eat subscale will be calculated. This subscale score is a mean, with minimum of 1 and maximum of 5 (higher scores = more pressure to eat, a worse outcome). | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Restriction (Parent-report) | Scores on the Child Feeding Questionnaire (CFQ)-Restriction subscale will be calculated. A mean is calculated for this subscale (min = 1 to max = 5). Higher scores = greater restriction of food (poorer outcome). | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Emotional Feeding (Parent-report) | Child Feeding Questionnaire (CFQ)- Emotional Feeding subscale will be calculated with a mean of responses to items. Min = 1 to max = 5. Higher scores reflect worse outcome. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Instrumental Feeding (Parent-report) | Scores on the Parental Feeding Questionnaire (PFQ)- Instrumental Feeding subscale will be calculated. Mean calculation of responses, with scores ranging from 1 (min) to 5 (max). Higher scores reflect poorer outcome. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Active Mediation of Television (Parent-report) | Scores on the Instructive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Restrictive Mediation of Television (Parent-report) | Scores on the Restrictive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Social Coviewing of Television (Parent-report) | Scores on the Social Coviewing subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Location/Quantity of Screen Media in the Home (Parent-report) | Parents will report on the location/quantity of screen media in home and child's bedroom. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Media Parenting Practices (Observed) | Family mealtime observations will be coded for presence and use of screen media (TV, mobile device present, other media present). Coding of the observed behavior is as follows: TV on = 1 if TV is on during mealtime, TV on = 0 if TV is off during mealtime, lower values = better outcomes. Mobile device present = 1 if a mobile device is present, 0 if no mobile device is present, with lower values= better outcomes. Other media present = 1 if other screens are present, 0 if no other screens are present (lower values=better outcomes). | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Parent Feeding Practices (Observed) | Family mealtime observations will be coded using a modified version of the Mealtime Interaction Coding System. Aspects of task accomplishment (TA) and behavior control BC) were coded. Scores could range from 1 (min) to 3 (max), with higher scores = better outcomes. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Child Psychological Functioning (Parent Report) | Behavior Assessment System for Children (BASC-3); internalizing symptoms t-score (lower scores better outcome) and adaptive skills t-score (higher scores better outcome). T-scores M = 50, SD = 10, with clinical cut-offs at 70 or above. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| Child Psychosocial Strengths (Parent Report) | Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes. | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
| BG001 | Wait List Control | Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Child age reported. | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Separated by child and caregiver data. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Separated by caregiver and child data. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Separated by child and caregiver data. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) z-score | Child Body Mass Index (BMI) z-score. This z-score is a standard deviation away from the mean, based on the Centers for Disease Control and Prevention (CDC) growth charts. Higher z-scores indicate greater weight status. A Z-score of 0 equals the population mean, based on age and sex. | This measure was specific to child participants (child BMI z-score). | Mean | Standard Deviation | Z-score |
|
| BMI percentile | This measure was specific to child participants (child BMI percentile). | This measure was specific to child participants (child BMI percentile). | Mean | Standard Deviation | percentile |
|
| OG001 | Wait List Control | Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection. |
|
|
|
| Secondary | Child Self-regulation (Parent Report) | Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4 | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Child Screen Time | Parent report of weekly amount of time child spends viewing/using screen media. Scores range from 0-168, with total scores reflecting sum of daily screen time across multiple types of screen media. Higher scores = more screen time. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Deviation | Hours per week | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Child Physical Activity | Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA) | Smaller n due to incomplete data (not wearing actigraph for minimum number of days). | Posted | Mean | Standard Error | minutes | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Child Sleep (Parent Report) | Measured by parent report of bedtime, wake time, and naps. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Deviation | hours | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Child Sleep (Via Actigraphy) | Measured by Actigraph accelerometer. | Incomplete actigraphy data due to participants wearing actigraph for fewer than minimum required days needed to calculate sleep. | Posted | Mean | Standard Error | hours | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Child Problematic Media Use | Measured by the parent-report via Problematic Media Use Measure (Domoff et al., 2019). Higher scores = greater problematic media use. Total scores = mean of items; Min = 1 to Max = 5. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. Higher scores indicate higher problematic media use. | Posted | Mean | Standard Error | units on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Parent-child Relationship Quality (Observed) | Dyadic Parent-Child Interaction Coding System-IV (DPICS-IV) will be used. The DPICS provides a reliable measure of parent-child relationship quality (e.g., parents' child-centered skills, parent and child positive and negative physical and verbal interactions) and parent behavior management skills (e.g., use of contingent reinforcement, effective discipline, child compliance). This outcome reflects behavioral observation of parents' child-centered skills ("DO" skills) during child led play. This is a count variable that can range from 0 displayed skills (min) with no determined maximum. Higher numbers = more skills (better outcome). | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | Skills | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Parent-child Relationship Quality (Parent Report) | Scores on the Parent-child Dysfunctional Interaction (PCDI) subscale of the Parenting Stress Index will be used as the parent-report of parent-child relationship quality. Values range from 12 to 60, with higher scores indicating greater dysfunction in (poorer quality of) the parent-child relationship. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Pressure to Eat (Parent-report) | Scores on the Child Feeding Questionnaire (CFQ)- Pressure to Eat subscale will be calculated. This subscale score is a mean, with minimum of 1 and maximum of 5 (higher scores = more pressure to eat, a worse outcome). | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Restriction (Parent-report) | Scores on the Child Feeding Questionnaire (CFQ)-Restriction subscale will be calculated. A mean is calculated for this subscale (min = 1 to max = 5). Higher scores = greater restriction of food (poorer outcome). | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Emotional Feeding (Parent-report) | Child Feeding Questionnaire (CFQ)- Emotional Feeding subscale will be calculated with a mean of responses to items. Min = 1 to max = 5. Higher scores reflect worse outcome. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Instrumental Feeding (Parent-report) | Scores on the Parental Feeding Questionnaire (PFQ)- Instrumental Feeding subscale will be calculated. Mean calculation of responses, with scores ranging from 1 (min) to 5 (max). Higher scores reflect poorer outcome. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Active Mediation of Television (Parent-report) | Scores on the Instructive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Restrictive Mediation of Television (Parent-report) | Scores on the Restrictive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Social Coviewing of Television (Parent-report) | Scores on the Social Coviewing subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Location/Quantity of Screen Media in the Home (Parent-report) | Parents will report on the location/quantity of screen media in home and child's bedroom. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | number of screens | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Media Parenting Practices (Observed) | Family mealtime observations will be coded for presence and use of screen media (TV, mobile device present, other media present). Coding of the observed behavior is as follows: TV on = 1 if TV is on during mealtime, TV on = 0 if TV is off during mealtime, lower values = better outcomes. Mobile device present = 1 if a mobile device is present, 0 if no mobile device is present, with lower values= better outcomes. Other media present = 1 if other screens are present, 0 if no other screens are present (lower values=better outcomes). | Family mealtime recordings were provided by one caregiver. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Secondary | Parent Feeding Practices (Observed) | Family mealtime observations will be coded using a modified version of the Mealtime Interaction Coding System. Aspects of task accomplishment (TA) and behavior control BC) were coded. Scores could range from 1 (min) to 3 (max), with higher scores = better outcomes. | One caregiver submitted family mealtime observations per family. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Other Pre-specified | Child Disruptive Behaviors (Parent Report) | Eyberg Child Behavior Inventory (ECBI); intensity t-score. Higher t-scores indicate poorer outcomes (i.e., greater intensity of behavior problems). T-scores have a mean of 50 (SD = 10). T-scores of 60 or higher indicate clinical significance. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | T-score | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Other Pre-specified | Child Psychological Functioning (Parent Report) | Behavior Assessment System for Children (BASC-3); internalizing symptoms t-score (lower scores better outcome) and adaptive skills t-score (higher scores better outcome). T-scores M = 50, SD = 10, with clinical cut-offs at 70 or above. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | T-score | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Other Pre-specified | Child Psychosocial Strengths (Parent Report) | Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes. | Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. | Posted | Mean | Standard Error | score on a scale | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| Primary | Change in Child Body Mass Index (BMI) Z-score | Change in child BMI z-score will be calculated using standardized anthropometric measurement (height and weight) procedure. The z-score is a standard deviation away from the mean, based on the CDC growth charts. Higher z-scores indicate greater weight status. A Z-score of 0 equals the population mean, based on age and sex. | For Time 2, n = 11 for PCIT-health and n = 7 for control. For Time 3, n = 9 for PCIT-health and n = 6 for control. | Posted | Mean | Standard Error | Z-score | Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention) |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Wait List Control | Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection. | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Change from T3 to T1 on ER subscale |
|
|
Effect size: 0.79
| Difference on difference for emotion regulation subscale from T3 to T1 | ANOVA | Repeated measures | 0.96 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.01 | Standard Error of the Mean | 0.14 | 2-Sided | Superiority | Effect size: -0.02 |
| Change in weekly screen time from T3 to T1 |
|
|
Effect size: -0.41
| Difference on difference for child weekly screen time from T3 to T1 | ANOVA | Repeated measures | 0.43 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 5.83 | Standard Error of the Mean | 7.17 | 2-Sided | Superiority | Effect size: 0.42 |
| Change in Moderate-Vigorous Physical Activity minutes from T3 to T1 (higher scores = more activity) |
|
|
| Change in Sedentary minutes from T2 to T1 (higher scores = less activity) |
|
|
| Change in Sedentary minutes from T3 to T1 (higher scores = less activity) |
|
|
Effect size: 0.85
| Difference on difference score for MVPA minutes from T3 to T1 | ANOVA | Repeated measures | 0.61 | Mean Difference (Net) | 16.09 | Standard Error of the Mean | 30.32 | 2-Sided | Superiority | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Effect size: 0.35 |
| Difference on difference score for sedentary minutes from T2 to T1 | ANOVA | Repeated measures | 0.26 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -64.40 | Standard Error of the Mean | 54.50 | 2-Sided | Superiority | Effect size: -0.68 |
| Difference on difference score for sedentary minutes from T3 to T1 | ANOVA | repeated measures | 0.34 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 66.25 | Standard Error of the Mean | 66.43 | 2-Sided | Superiority | effect size: 0.66 |
| Change in hours of sleep from T3 to T1 |
|
|
effect size: -0.41
| Difference on difference for parent-reported sleep time from T3 to T1 | ANOVA | repeated measures | 0.16 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 1.39 | Standard Error of the Mean | 0.95 | 2-Sided | Superiority | effect size: 0.76 |
| Change in minutes of sleep from T3 to T1 |
|
|
effect size: -0.54
| Difference on difference for actigraphy-recorded sleep time from T3 to T1 | ANOVA | repeated measures | 0.04 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -38.83 | Standard Error of the Mean | 16.61 | 2-Sided | Superiority | effect size: -1.56 |
| Change in problematic media use from T3 to T1 |
|
|
effect size: 0.15
| Difference on difference for problematic media use from T3 to T1 | ANOVA | repeated measures | 0.47 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.21 | Standard Error of the Mean | 0.28 | 2-Sided | Superiority | effect size: -0.38 |
| Change in child-centered skills from T3 to T1 |
|
|
effect size: 1.65
| Difference on difference for child-centered skills from T3 to T1 | ANOVA | repeated measures | 0.05 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 8.22 | Standard Error of the Mean | 3.81 | 2-Sided | Superiority | effect size: 1.20 |
| Change in PCDI from T3 to T1 |
|
|
| Difference on difference for PCDI scores from T3 to T1 | ANOVA | repeated measures | 0.008 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -19.43 | Standard Error of the Mean | 6.40 | 2-Sided | Superiority | effect size: -1.57 |
| Change in pressure to eat scores from T3 to T1 |
|
|
effect size: -0.34
| Difference on difference for pressure to eat scores from T3 to T1 | ANOVA | repeated measures | 0.98 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.01 | Standard Error of the Mean | 0.37 | 2-Sided | Superiority | effect size: -0.01 |
| Change in Restriction scores from T3 to T1 |
|
|
effect size: -0.70
| Difference on difference for restrictive feeding scores from T3 to T1 | ANOVA | repeated measures | 0.34 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.35 | Standard Error of the Mean | 0.35 | 2-Sided | Superiority | effect size: -0.51 |
| Change in emotional feeding from T3 to T1 |
|
|
effect size: -0.06
| Difference on difference for emotional feeding scores from T3 to T1 | ANOVA | repeated measures | 0.45 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.17 | Standard Error of the Mean | 0.22 | 2-Sided | Superiority | effect size: -0.40 |
| Change in instrumental feeding from T3 to T1 |
|
|
effect size: -1.12
| Difference on difference for instrumental feeding scores from T3 to T1 | ANOVA | repeated measures | 0.03 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.55 | Standard Error of the Mean | 0.23 | 2-Sided | Superiority | effect size: -1.25 |
| Change in active mediation from T3 to T1 |
|
|
| Difference on difference for active mediation scores from T3 to T1 | ANOVA | repeated measures | 0.11 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 2.50 | Standard Error of the Mean | 1.47 | 2-Sided | Superiority | effect size: 0.88 |
| Change in restrictive mediation from T3 to T1 |
|
|
effect size: 1.77
| Difference on difference for restrictive mediation scores from T3 to T1 | ANOVA | repeated measures | 0.24 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 1.30 | Standard Error of the Mean | 1.08 | 2-Sided | Superiority | effect size: 0.63 |
| Change in social coviewing from T3 to T1 |
|
|
| Difference on difference for social coviewing from T3 to T1 | ANOVA | repeated measures | 0.77 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 0.33 | Standard Error of the Mean | 1.10 | 2-Sided | Superiority | effect size: 0.15 |
| Change in number of screens in the child's bedroom from T2 to T1 |
|
| Change in number of screens in the child's bedroom from T3 to T1 |
|
effect size: 0.04
| Difference on difference for number of screens in the home from T3 to T1 | ANOVA | repeated measures | 0.64 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 0.65 | Standard Error of the Mean | 1.36 | 2-Sided | Superiority | effect size: 0.17 |
| Difference on difference for number of screens in child bedroom from T2 to T1 | ANOVA | repeated measures | 0.31 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.36 | Standard Error of the Mean | 0.34 | 2-Sided | Superiority | effect size: -0.36 |
| Difference on difference for number of screens in child bedroom from T3 to T1 | ANOVA | repeated measures | 0.04 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.91 | Standard Error of the Mean | 0.39 | 2-Sided | Superiority | effect size: -0.85 |
| Change in TV on during mealtime from T3 to T1 |
|
|
| Change in mobile device present during mealtime from T2 to T1 |
|
|
| Change in mobile device present during mealtime from T3 to T1 |
|
|
| Change in other media present during mealtime from T2 to T1 |
|
|
| Change in other media present during mealtime from T3 to T1 |
|
|
effect size: -1.25
| Difference on difference for TV on during mealtime from T3 to T1 | ANOVA | repeated measures | 0.10 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided | Mean Difference (Net) | -0.33 | Standard Error of the Mean | 0.19 | 2-Sided | Superiority | effect size: -1.08 |
| Difference on difference for mobile device present during mealtime from T2 to T1 | ANOVA | repeated measures | 0.41 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.20 | Standard Error of the Mean | 0.24 | 2-Sided | Superiority | effect size: -0.44 |
| Difference on difference for mobile device present during mealtime from T3 to T1 | ANOVA | repeated measures | 0.21 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.29 | Standard Error of the Mean | 0.22 | 2-Sided | Superiority | effect size: -0.80 |
| Difference on difference for other media present during mealtime from T2 to T1 | ANOVA | repeated measures | 0.02 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.40 | Standard Error of the Mean | 0.16 | 2-Sided | Superiority | effect size: -1.29 |
| Difference on difference for other media present during mealtime from T3 to T1 | ANOVA | repeated measures | 0.20 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.22 | Standard Error of the Mean | 0.16 | 2-Sided | Superiority | effect size: -0.82 |
| Change in TA score during mealtime from T3 to T1 |
|
|
| Change in BC score during mealtime from T2 to T1 |
|
|
| Change in BC score during mealtime from T3 to T1 |
|
|
effect size: 1.55
| Difference on difference for mealtime task accomplishment scores from T3 to T1 | ANOVA | repeated measures | 0.84 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.03 | Standard Error of the Mean | 0.15 | 2-Sided | Superiority | effect size: -0.13 |
| Difference on difference for mealtime behavior control scores from T2 to T1 | ANOVA | repeated measures | 0.24 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 0.24 | Standard Error of the Mean | 0.20 | 2-Sided | Superiority | effect size: 0.63 |
| Difference on difference for mealtime behavior control scores from T3 to T1. | ANOVA | repeated measures | 0.84 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -0.03 | Standard Error of the Mean | 0.15 | 2-Sided | Superiority | effect size: -0.13 |
| Change in ECBI intensity t-score from T3 to T1 |
|
|
effect size: -1.50
| Difference on difference for ECBI intensity t-scores from T3 to T1 | ANOVA | repeated measures | 0.01 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -7.63 | Standard Error of the Mean | 2.48 | 2-Sided | Superiority | effect size: -1.12 |
| Change in internalizing symptoms from T3 to T1 |
|
|
| Change in adaptive skills from T2 to T1 |
|
|
| Change in adaptive skills from T3 to T1 |
|
|
effect size: -0.93
| Difference on difference for internalizing symptoms from T3 to T1 | ANOVA | repeated measures | 0.08 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -6.58 | Standard Error of the Mean | 3.56 | 2-Sided | Superiority | effect size: -0.68 |
| Difference on difference for adaptive skills from T2 to T1 | ANOVA | repeated measures | 0.36 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -6.47 | Standard Error of the Mean | 6.92 | 2-Sided | Superiority | effect size: -0.33 |
| Difference on difference for adaptive skills from T3 to T1 | ANOVA | Repeated measures | 0.69 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | -3.57 | Standard Error of the Mean | 8.83 | 2-Sided | Superiority | effect size: -0.15 |
| Change in PSICA intensity from T3 to T1 |
|
|
effect size: 1.70
| Difference on difference for PSICA intensity scores from T3 to T1 | ANOVA | repeated measures | 0.01 | Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided. | Mean Difference (Net) | 21.78 | Standard Error of the Mean | 7.64 | 2-Sided | Superiority | effect size: 1.04 |
| Change in BMI z-score (T3-T1); negative values indicate decrease in BMI z-score |
|
|
| Difference on difference for BMI z-scores from T3 to T1. | ANOVA | Repeated measures | .98 | Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size. | Mean Difference (Net) | 0.00 | Standard Error of the Mean | 0.18 | 2-Sided | Superiority | Effect size: -0.01 |