Improving Parent-Child Interactions to Prevent Child Obesity in Early Childhood
Phase: NA
Conditions: Child Obesity
Sponsor: Central Michigan University

Document Cover Page 
Official Title of the Study: Improving Parent-Child Interactions to Enhance Child Health 
NCT Number: NCT03982511 
Date of Document: 4/5/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol and Statistical Analysis Plan (SAP) 
 
Study Protocol 
After determining eligibility, potential participants will be invited to the Center for 
Children, Families, and Communities (CCFC) to provide consent and complete baseline 
measures. Following completion of clinic-based baseline measures, participants will be 
instructed on how to complete home-based baseline measures (e.g., family mealtime 
recordings, Actigraphs). One week later, research assistants will obtain home-based 
assessments from families’ homes. After these assessments are completed, research 
assistants will inform families whether they have been randomly assigned to 
intervention or waitlist control condition. Random assignment will be determined by 
random number generator and stratified by child sex. See Table 1 for assessment 
protocol and timeline. Participants in the intervention condition will receive PCIT-Health 
and participants in the waitlist control condition will be offered the intervention after 6-
month post-intervention measures are completed (i.e., 10 months after they have 
enrolled in the study). After baseline, assessments will occur: (1) at completion of PCIT-
Health intervention and (2) at 6-months post-intervention completion. All participants 
(regardless of condition) will complete these additional assessments after baseline. In 
other words, all participants will complete three different assessments. 
PCIT-Health Intervention 
Given that the pandemic necessitated virtual delivery of treatment, a telehealth version 
of PCIT-Health was delivered. See Domoff et al. (2022) for how PCIT-Health (Domoff & 
Niec, 2018) was adapted to be delivered through virtual conferencing. PCIT-Health 
consists of three phases: Child-Directed Interaction (CDI), Parent-Directed Interaction 
(PDI), and Health-Directed Interaction (HDI; Domoff & Niec, 2018). During CDI, parents 
learn child-centered play/interaction skills to enhance the parent-child relationship. 
During PDI, parents learn age/developmentally- appropriate discipline skills. In the HDI 
teaching session, we provide psycho-education about beneficial parenting practices in 
areas specific to children’s weight-related behaviors: parental feeding practices and 
parenting around screen time (i.e., media parenting). Three coaching sessions (guided 
and reinforced implementation of skills learned in the teaching session) focus on two 
primary contexts where children are socialized around eating and activity: (1) family 
mealtime and (2) unstructured child play/free time (see Domoff et al., 2022 & Domoff & 
Niec, 2018 for more comprehensive descriptions of the sessions).  
References: 
Domoff, S. E., & Niec, L. N. (2018). Parent-child interaction therapy as a prevention 
model for childhood obesity: A novel application for high-risk families. Children and 
Youth Services Review, 91, 77-84. 
 

Domoff, S. E., Overton, M. M., Borgen, A. L., & Niec, L. N. (2022). Adapting PCIT-
Health for Telehealth Delivery: A Case Study. International Journal of Environmental 
Research and Public Health, 19(14), 8352. 
 
Measures 
Feasibility and Acceptability Measures (AIM 1) 
Feasibility and acceptability measures will be administered once, at treatment 
completion. The acceptability of PCIT-Health will be measured by the Abbreviated 
Acceptability Rating Profile (AARP) and Therapy Attitude Inventory (TAI), which 
assesses parents’ satisfaction with parent training interventions. Both measures have 
strong psychometric properties. The Barriers to Treatment Participation Scale (BTPS) 
will be administered as well.  
Primary (AIM 2) and Secondary (AIM 3) Outcome Measures  
The following measures will be assessed at each time point (baseline, post-treatment, 
and 6-month follow-up). There has been increasing recognition of need for 
observational measures of parenting; as such, we will assess secondary outcomes of 
PCIT-Health (e.g., parent-child relationship quality, and parent behavior management 
skills in general and obesity-specific contexts) using both observational and parent-
report measures (see below and Table 1 for assessment visit 
activities). 
Child Anthropometrics 
Change of child BMI z-score from baseline to (1) completion 
of PCIT-Health and (2) six-month follow-up will be calculated 
as the primary outcome variable (AIM 2). Child height and 
weight will be measured by trained research assistants, using 
a Detecto Portable Scale Model and a Seca portable 
stadiometer. Children will be weighed twice and if the two 
readings differed by more than 0.1 kg, the child will be 
weighed two more times. For the height measurement, the 
child’s position and posture will be checked, and height will 
also be measured twice. As with weight, if measurements 
differ by more than 0.5 cm, two more measurements will be 
taken. BMI will be calculated and the child BMI z-score will be 
derived using age- and sex-specific norms.  
Child Self-Regulation  
Emotion Regulation Checklist (ERC) is a 24-item parent-report measure that 
assesses parents’ perception of their child’s affective regulation and emotionality. Two 
subscales are calculated based on parent responses. The first, Emotion Regulation, 
Table 1. Protocol 
Time 
Activity 
Clinic Assessments 
4pm 
Instructions for Clinic 
Visit 
4:15 
Parent completes 
questionnaires 
5:15 
DPICS protocol 
5:45 
Child and caregiver 
anthropometry 
5:55 
Instructions for home 
based measures 
Home Assessments 
Frequency/Description 
3 
dinners 
Family Mealtime 
Recordings 
7 days 
Actigraph 
assessments 

assesses a child’s adaptive regulation and expression or emotion. The 
second, Lability/Negativity, assesses a child’s emotional intensity, negative reactivity, 
and dysregulation of positive emotions.   
Child Weight-Related Behaviors  
Child Screen Time. Caregivers will report on children’s typical weekday and weekend 
screen time (including TV, tablet, computer, video game use). Items request caregivers 
to give estimates based on different parts of the day (e.g., “How many hours did your 
child [watch TV/videos/use mobile device/use computer/play video games] from the 
time he/she wakes up until going to [daycare/preschool]” to facilitate recall. Parents will 
also report on Problematic Media Use (Domoff et al.,2019). 
Child Physical Activity. Objective measures of habitual physical activity will be 
monitored by a wGT3X-BT Actigraph accelerometer (ActiGraph of Ft. Pensacola, FL) 
and analysis with ActiLife6 software (ActiGraph of Ft. Pensacola, FL). Participants will 
be asked to wear the device for seven consecutive days while they are awake and to 
remove it while swimming or bathing. Any block of time greater than or equal to 60 
minutes where the activity count is equal to zero will be considered time when the 
monitor was not worn. Each minute of accelerometer data will be coded based on the 
recorded activity counts for that minute associated with sedentary, moderate, moderate-
to-vigorous, and vigorous physical activity as previously described in children.  
Parent-Child Relationship Quality 
Dyadic Parent-Child Interaction Coding System-IV (DPICS-IV). The DPICS is a 
standardized, behavior observation measure of parent-child interactions during three 
situations in which parents must exert increasing control over their children. It provides 
a reliable measure of parenting behaviors (e.g., child-centered skills, positive and 
negative physical interaction, use of contingent reinforcement). 
Parenting Stress Index, Fourth Edition, Short Form (PSI-4/SF). The PSI-4/SF is a 
36-item self-report measure assessing parenting distress in parents of children 3 
months to 12 years of age. Three subscales are included: Parental Distress assesses 
distress related to a respondent’s role as a parent; Parent-child Dysfunctional 
Interaction assesses distress associated with a parent’s relationship with a target child; 
Difficult Child (DC) assesses distress associated with a target child’s difficult behaviors. 
The PSI has demonstrated good to excellent reliability and validity, including internal 
consistency, test-retest reliability, and discriminate and factorial validity. Scores on the 
Parent-child Dysfunctional Interaction subscale will be used as the parent-report of 
parent-child relationship quality. 
Parent Behavior Management Skills in General and Obesity-Specific Contexts 
Parent behavior management skills in general (non-obesity specific contexts) will be 
measured by the DPICS-IV. Parent behavior management skills in obesity-specific 
contexts will be measured in the domains of feeding and screen media use. Parents will 

complete self-report measures (detailed below) and research assistants will code 
recordings of family mealtime observations to assess behavior management skills in the 
obesity-specific context. 
Parent feeding practices and styles. How caregivers feed their children will be 
measured by parent report on the subscales of Pressure to Eat and Restriction on the 
Child Feeding Questionnaire (CFQ) and Caregivers’ Feeding Styles Questionnaire, 
Emotional feeding (using food to help regulate child’s emotions) and instrumental 
feeding (using food as a reward) will be measured with respective subscales on the 
Parental Feeding Style Questionnaire.  
Media parenting practices. Parenting practices related to children’s media exposure 
and screen time will be measured by self-report, using the Parental Mediation Scale. 
This Scale measures three types of media parenting: active mediation, co-viewing, and 
restrictive mediation and has strong psychometric properties. Caregivers will also report 
on other aspects of media parenting practices related to child obesity risk, including the 
number of screens in the home and in the child’s bedroom.  
Observational Coding of Parenting during Mealtime. Family mealtime characteristics 
and interactions will be assessed through coding of recorded family mealtimes. 
Caregivers will be provided a videorecorder and tripod and instructed how to record 
three typical dinnertime meals in the home. These video recordings will be coded for a 
variety of behaviors. Parent feeding behaviors will be coded using an adapted version 
of the Mealtime Interaction Coding System. Media parenting practices (e.g., presence 
of screen media, type(s) of screen media present, TV on) during mealtime will be 
coded. 
 
Statistical Analysis Plan 
Aim 1. To assess the acceptability and feasibility of the PCIT-Health intervention 
delivery and assessment methods. 
To address Aim 1, descriptive statistics (e.g., means and frequencies) of the parent-
report measures assessing acceptability of PCIT-Health (e.g., AARP, TAI, and BTPS) 
will be calculated. Proportions of treatment completers to enrollees will be calculated as 
well as frequencies of total sessions attended. In addition we will use multivariate 
regression models to identify factors that increase/decrease PCIT-health participation. 
Such information would be valuable and will be used to enhance participation in the 
program. 
Aim 2.  To test the preliminary efficacy and estimate the effect size of PCIT-Health in 
parent-child dyads randomly assigned to PCIT-Health or wait-list control on change in 
child BMI z-score (primary outcome) from baseline to (1) treatment completion and (2) 
6-month post-intervention follow-up. 
Repeated measure ANOVA will be used for testing change in child BMI z-scores 
between (1) baseline and post-intervention and (2) baseline and 6 month follow up will 

be conducted. Given that the sample size is not very large for this study, we will report 
both statistical significance as well as the effect size. The magnitude of the effect size 
would show the potential effect of PCIT-Health when applied to a larger population.  
Aim 3. To explore the effect of PCIT-Health on the following secondary outcomes: (1) 
child self-regulation, (2) child eating behaviors, (3) physical activity, and (4) child screen 
media use. 
Similar to Aim 2, repeated measure ANOVA will be used for testing change in 
secondary outcomes between (1) baseline and post-intervention and (2) baseline and 6 
month follow up will be conducted. Both the significance level and the effect size will be 
reported to fully understand the magnitude of the treatment effect.