Trial Outcomes & Findings for Improving Parent-Child Interactions to Enhance Child Health (NCT NCT03982511)

NCT ID: NCT03982511

Last Updated: 2023-09-15

Results Overview

Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

Pre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention)

Results posted on

2023-09-15

Participant Flow

After enrollment (providing consent), but before assignment, two families declined to continue participating in the study. (n = 4).

Participant milestones

Participant milestones
Measure
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.
Wait List Control
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Overall Study
STARTED
41
18
Overall Study
COMPLETED
30
15
Overall Study
NOT COMPLETED
11
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Separated by child and caregiver data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PCIT-Health
n=41 Participants
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.
Wait List Control
n=18 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Total
n=59 Participants
Total of all reporting groups
Age, Categorical
Child · <=18 years
14 Participants
n=14 Participants • Separated by child and caregiver data.
7 Participants
n=7 Participants • Separated by child and caregiver data.
21 Participants
n=21 Participants • Separated by child and caregiver data.
Age, Categorical
Child · Between 18 and 65 years
0 Participants
n=14 Participants • Separated by child and caregiver data.
0 Participants
n=7 Participants • Separated by child and caregiver data.
0 Participants
n=21 Participants • Separated by child and caregiver data.
Age, Categorical
Child · >=65 years
0 Participants
n=14 Participants • Separated by child and caregiver data.
0 Participants
n=7 Participants • Separated by child and caregiver data.
0 Participants
n=21 Participants • Separated by child and caregiver data.
Age, Categorical
Caregiver · <=18 years
0 Participants
n=27 Participants • Separated by child and caregiver data.
0 Participants
n=11 Participants • Separated by child and caregiver data.
0 Participants
n=38 Participants • Separated by child and caregiver data.
Age, Categorical
Caregiver · Between 18 and 65 years
27 Participants
n=27 Participants • Separated by child and caregiver data.
11 Participants
n=11 Participants • Separated by child and caregiver data.
38 Participants
n=38 Participants • Separated by child and caregiver data.
Age, Categorical
Caregiver · >=65 years
0 Participants
n=27 Participants • Separated by child and caregiver data.
0 Participants
n=11 Participants • Separated by child and caregiver data.
0 Participants
n=38 Participants • Separated by child and caregiver data.
Age, Continuous
53.36 months
STANDARD_DEVIATION 16.06 • n=14 Participants • Child age reported.
50.86 months
STANDARD_DEVIATION 11.95 • n=7 Participants • Child age reported.
52.52 months
STANDARD_DEVIATION 14.56 • n=21 Participants • Child age reported.
Sex: Female, Male
Child · Female
5 Participants
n=14 Participants • Separated by child and caregiver data.
3 Participants
n=7 Participants • Separated by child and caregiver data.
8 Participants
n=21 Participants • Separated by child and caregiver data.
Sex: Female, Male
Child · Male
9 Participants
n=14 Participants • Separated by child and caregiver data.
4 Participants
n=7 Participants • Separated by child and caregiver data.
13 Participants
n=21 Participants • Separated by child and caregiver data.
Sex: Female, Male
Caregiver · Female
16 Participants
n=27 Participants • Separated by child and caregiver data.
8 Participants
n=11 Participants • Separated by child and caregiver data.
24 Participants
n=38 Participants • Separated by child and caregiver data.
Sex: Female, Male
Caregiver · Male
11 Participants
n=27 Participants • Separated by child and caregiver data.
3 Participants
n=11 Participants • Separated by child and caregiver data.
14 Participants
n=38 Participants • Separated by child and caregiver data.
Ethnicity (NIH/OMB)
Child · Hispanic or Latino
1 Participants
n=14 Participants • Separated by caregiver and child data.
2 Participants
n=7 Participants • Separated by caregiver and child data.
3 Participants
n=21 Participants • Separated by caregiver and child data.
Ethnicity (NIH/OMB)
Child · Not Hispanic or Latino
13 Participants
n=14 Participants • Separated by caregiver and child data.
5 Participants
n=7 Participants • Separated by caregiver and child data.
18 Participants
n=21 Participants • Separated by caregiver and child data.
Ethnicity (NIH/OMB)
Child · Unknown or Not Reported
0 Participants
n=14 Participants • Separated by caregiver and child data.
0 Participants
n=7 Participants • Separated by caregiver and child data.
0 Participants
n=21 Participants • Separated by caregiver and child data.
Ethnicity (NIH/OMB)
Caregiver · Hispanic or Latino
1 Participants
n=27 Participants • Separated by caregiver and child data.
1 Participants
n=11 Participants • Separated by caregiver and child data.
2 Participants
n=38 Participants • Separated by caregiver and child data.
Ethnicity (NIH/OMB)
Caregiver · Not Hispanic or Latino
26 Participants
n=27 Participants • Separated by caregiver and child data.
10 Participants
n=11 Participants • Separated by caregiver and child data.
36 Participants
n=38 Participants • Separated by caregiver and child data.
Ethnicity (NIH/OMB)
Caregiver · Unknown or Not Reported
0 Participants
n=27 Participants • Separated by caregiver and child data.
0 Participants
n=11 Participants • Separated by caregiver and child data.
0 Participants
n=38 Participants • Separated by caregiver and child data.
Race (NIH/OMB)
Child · American Indian or Alaska Native
0 Participants
n=14 Participants • Separated by child and caregiver data.
0 Participants
n=7 Participants • Separated by child and caregiver data.
0 Participants
n=21 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Child · Asian
1 Participants
n=14 Participants • Separated by child and caregiver data.
0 Participants
n=7 Participants • Separated by child and caregiver data.
1 Participants
n=21 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Child · Native Hawaiian or Other Pacific Islander
0 Participants
n=14 Participants • Separated by child and caregiver data.
0 Participants
n=7 Participants • Separated by child and caregiver data.
0 Participants
n=21 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Child · Black or African American
0 Participants
n=14 Participants • Separated by child and caregiver data.
0 Participants
n=7 Participants • Separated by child and caregiver data.
0 Participants
n=21 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Child · White
12 Participants
n=14 Participants • Separated by child and caregiver data.
5 Participants
n=7 Participants • Separated by child and caregiver data.
17 Participants
n=21 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Child · More than one race
1 Participants
n=14 Participants • Separated by child and caregiver data.
2 Participants
n=7 Participants • Separated by child and caregiver data.
3 Participants
n=21 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Child · Unknown or Not Reported
0 Participants
n=14 Participants • Separated by child and caregiver data.
0 Participants
n=7 Participants • Separated by child and caregiver data.
0 Participants
n=21 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Caregiver · American Indian or Alaska Native
0 Participants
n=27 Participants • Separated by child and caregiver data.
0 Participants
n=11 Participants • Separated by child and caregiver data.
0 Participants
n=38 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Caregiver · Asian
2 Participants
n=27 Participants • Separated by child and caregiver data.
0 Participants
n=11 Participants • Separated by child and caregiver data.
2 Participants
n=38 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Caregiver · Native Hawaiian or Other Pacific Islander
0 Participants
n=27 Participants • Separated by child and caregiver data.
0 Participants
n=11 Participants • Separated by child and caregiver data.
0 Participants
n=38 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Caregiver · Black or African American
2 Participants
n=27 Participants • Separated by child and caregiver data.
0 Participants
n=11 Participants • Separated by child and caregiver data.
2 Participants
n=38 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Caregiver · White
23 Participants
n=27 Participants • Separated by child and caregiver data.
11 Participants
n=11 Participants • Separated by child and caregiver data.
34 Participants
n=38 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Caregiver · More than one race
0 Participants
n=27 Participants • Separated by child and caregiver data.
0 Participants
n=11 Participants • Separated by child and caregiver data.
0 Participants
n=38 Participants • Separated by child and caregiver data.
Race (NIH/OMB)
Caregiver · Unknown or Not Reported
0 Participants
n=27 Participants • Separated by child and caregiver data.
0 Participants
n=11 Participants • Separated by child and caregiver data.
0 Participants
n=38 Participants • Separated by child and caregiver data.
Region of Enrollment
United States
41 participants
n=41 Participants
18 participants
n=18 Participants
59 participants
n=59 Participants
Body Mass Index (BMI) z-score
0.71 Z-score
STANDARD_DEVIATION 1.21 • n=14 Participants • This measure was specific to child participants (child BMI z-score).
0.77 Z-score
STANDARD_DEVIATION 0.84 • n=7 Participants • This measure was specific to child participants (child BMI z-score).
0.73 Z-score
STANDARD_DEVIATION 1.08 • n=21 Participants • This measure was specific to child participants (child BMI z-score).
BMI percentile
68.09 percentile
STANDARD_DEVIATION 30.50 • n=14 Participants • This measure was specific to child participants (child BMI percentile).
73.94 percentile
STANDARD_DEVIATION 26.52 • n=7 Participants • This measure was specific to child participants (child BMI percentile).
70.04 percentile
STANDARD_DEVIATION 28.70 • n=21 Participants • This measure was specific to child participants (child BMI percentile).

PRIMARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention)

Population: 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.

Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure

Outcome measures

Outcome measures
Measure
PCIT-Health
n=11 Participants
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.
Wait List Control
n=7 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Change in Child Body Mass Index (BMI) Percentile
Change in BMI percentile (T2-T1); negative values indicate decrease in BMI percentile
3.66 percentile
Standard Error 2.29
1.74 percentile
Standard Error 3.24
Change in Child Body Mass Index (BMI) Percentile
Change in BMI percentile (T3-T1); negative values indicate decrease in BMI percentile
1.12 percentile
Standard Error 2.56
0.88 percentile
Standard Error 3.72

PRIMARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: 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.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=11 Participants
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.
Wait List Control
n=7 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Change in Child Body Mass Index (BMI) Z-score
Change in BMI z-score (T2-T1); negative values indicate decrease in BMI z-score
0.11 Z-score
Standard Error 0.08
0.06 Z-score
Standard Error 0.12
Change in Child Body Mass Index (BMI) Z-score
Change in BMI z-score (T3-T1); negative values indicate decrease in BMI z-score
0.01 Z-score
Standard Error 0.10
0.02 Z-score
Standard Error 0.15

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Self-regulation (Parent Report)
Change from T2 to T1 on ER subscale
0.23 units on a scale
Standard Deviation 0.31
0.03 units on a scale
Standard Deviation 0.38
Child Self-regulation (Parent Report)
Change from T3 to T1 on ER subscale
0.26 units on a scale
Standard Deviation 0.29
0.26 units on a scale
Standard Deviation 0.42

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Screen Time
Change in weekly screen time from T2 to T1
-5.72 Hours per week
Standard Deviation 12.52
0.36 Hours per week
Standard Deviation 18.37
Child Screen Time
Change in weekly screen time from T3 to T1
-2.92 Hours per week
Standard Deviation 12.08
-8.75 Hours per week
Standard Deviation 26.62

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Smaller n due to incomplete data (not wearing actigraph for minimum number of days).

Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA)

Outcome measures

Outcome measures
Measure
PCIT-Health
n=10 Participants
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.
Wait List Control
n=6 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Physical Activity
Change in Moderate-Vigorous Physical Activity minutes from T2 to T1 (higher scores = more activity)
38.26 minutes
Standard Error 13.78
2.94 minutes
Standard Error 19.48
Child Physical Activity
Change in Moderate-Vigorous Physical Activity minutes from T3 to T1 (higher scores = more activity)
32.55 minutes
Standard Error 18.40
16.46 minutes
Standard Error 24.09
Child Physical Activity
Change in Sedentary minutes from T2 to T1 (higher scores = less activity)
-59.17 minutes
Standard Error 31.46
5.23 minutes
Standard Error 44.50
Child Physical Activity
Change in Sedentary minutes from T3 to T1 (higher scores = less activity)
14.59 minutes
Standard Error 40.32
-51.65 minutes
Standard Error 52.79

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

Measured by parent report of bedtime, wake time, and naps.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Sleep (Parent Report)
Change in hours of sleep from T2 to T1
-1.0 hours
Standard Deviation 2.25
-0.36 hours
Standard Deviation 1.50
Child Sleep (Parent Report)
Change in hours of sleep from T3 to T1
-1.05 hours
Standard Deviation 2.68
-2.44 hours
Standard Deviation 1.33

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Incomplete actigraphy data due to participants wearing actigraph for fewer than minimum required days needed to calculate sleep.

Measured by Actigraph accelerometer.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=9 Participants
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.
Wait List Control
n=5 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Sleep (Via Actigraphy)
Change in minutes of sleep from T2 to T1
-10.15 hours
Standard Error 8.19
2.47 hours
Standard Error 12.38
Child Sleep (Via Actigraphy)
Change in minutes of sleep from T3 to T1
-29.54 hours
Standard Error 10.10
9.29 hours
Standard Error 13.22

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: 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.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Problematic Media Use
Change in problematic media use from T2 to T1
-0.30 units on a scale
Standard Error 0.15
-0.38 units on a scale
Standard Error 0.21
Child Problematic Media Use
Change in problematic media use from T3 to T1
-0.36 units on a scale
Standard Error 0.16
-0.15 units on a scale
Standard Error 0.23

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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).

Outcome measures

Outcome measures
Measure
PCIT-Health
n=19 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Parent-child Relationship Quality (Observed)
Change in child-centered skills from T2 to T1
7.65 Skills
Standard Error 1.57
0.00 Skills
Standard Error 2.12
Parent-child Relationship Quality (Observed)
Change in child-centered skills from T3 to T1
6.35 Skills
Standard Error 1.99
-0.11 Skills
Standard Error 2.73

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Parent-child Relationship Quality (Parent Report)
Change in PCDI from T2 to T1
-9.59 score on a scale
Standard Error 4.00
7.64 score on a scale
Standard Error 5.66
Parent-child Relationship Quality (Parent Report)
Change in PCDI from T3 to T1
-13.21 score on a scale
Standard Error 3.63
6.22 score on a scale
Standard Error 5.27

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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).

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Pressure to Eat (Parent-report)
Change in pressure to eat scores from T2 to T1
-0.84 score on a scale
Standard Error 0.21
-0.59 score on a scale
Standard Error 0.29
Pressure to Eat (Parent-report)
Change in pressure to eat scores from T3 to T1
-0.59 score on a scale
Standard Error 0.21
-0.58 score on a scale
Standard Error 0.31

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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).

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Restriction (Parent-report)
Change in Restriction scores from T2 to T1
-0.71 score on a scale
Standard Error 0.18
-0.25 score on a scale
Standard Error 0.26
Restriction (Parent-report)
Change in Restriction scores from T3 to T1
-0.88 score on a scale
Standard Error 0.20
-0.53 score on a scale
Standard Error 0.29

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Emotional Feeding (Parent-report)
Change in emotional feeding from T2 to T1
-0.19 score on a scale
Standard Error 0.13
-0.16 score on a scale
Standard Error 0.19
Emotional Feeding (Parent-report)
Change in emotional feeding from T3 to T1
-0.37 score on a scale
Standard Error 0.12
-0.20 score on a scale
Standard Error 0.18

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Instrumental Feeding (Parent-report)
Change in instrumental feeding from T2 to T1
-0.74 score on a scale
Standard Error 0.12
-0.27 score on a scale
Standard Error 0.16
Instrumental Feeding (Parent-report)
Change in instrumental feeding from T3 to T1
-0.91 score on a scale
Standard Error 0.13
-0.36 score on a scale
Standard Error 0.19

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Active Mediation of Television (Parent-report)
Change in active mediation from T2 to T1
2.86 score on a scale
Standard Error 0.61
0.64 score on a scale
Standard Error 0.86
Active Mediation of Television (Parent-report)
Change in active mediation from T3 to T1
2.95 score on a scale
Standard Error 0.84
0.44 score on a scale
Standard Error 1.21

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Restrictive Mediation of Television (Parent-report)
Change in restrictive mediation from T2 to T1
2.36 score on a scale
Standard Error 0.57
-1.27 score on a scale
Standard Error 0.81
Restrictive Mediation of Television (Parent-report)
Change in restrictive mediation from T3 to T1
1.53 score on a scale
Standard Error 0.61
0.22 score on a scale
Standard Error 0.89

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Social Coviewing of Television (Parent-report)
Change in social coviewing from T2 to T1
1.14 score on a scale
Standard Error 0.61
0.45 score on a scale
Standard Error 0.86
Social Coviewing of Television (Parent-report)
Change in social coviewing from T3 to T1
1.11 score on a scale
Standard Error 0.63
0.78 score on a scale
Standard Error 0.91

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

Parents will report on the location/quantity of screen media in home and child's bedroom.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=19 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Location/Quantity of Screen Media in the Home (Parent-report)
Change in number of screens in the home from T2 to T1
0.32 number of screens
Standard Error 0.89
0.18 number of screens
Standard Error 1.18
Location/Quantity of Screen Media in the Home (Parent-report)
Change in number of screens in the home from T3 to T1
0.49 number of screens
Standard Error 0.94
-0.39 number of screens
Standard Error 1.30
Location/Quantity of Screen Media in the Home (Parent-report)
Change in number of screens in the child's bedroom from T2 to T1
-0.21 number of screens
Standard Error 0.22
0.19 number of screens
Standard Error 0.30
Location/Quantity of Screen Media in the Home (Parent-report)
Change in number of screens in the child's bedroom from T3 to T1
-0.58 number of screens
Standard Error 0.22
0.33 number of screens
Standard Error 0.32

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Family mealtime recordings were provided by one caregiver.

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).

Outcome measures

Outcome measures
Measure
PCIT-Health
n=11 Participants
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.
Wait List Control
n=7 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Media Parenting Practices (Observed)
Change in TV on during mealtime from T2 to T1
-0.39 score on a scale
Standard Error 0.11
0.11 score on a scale
Standard Error 0.18
Media Parenting Practices (Observed)
Change in TV on during mealtime from T3 to T1
-0.33 score on a scale
Standard Error 0.10
0.00 score on a scale
Standard Error 0.16
Media Parenting Practices (Observed)
Change in mobile device present during mealtime from T2 to T1
-0.09 score on a scale
Standard Error 0.12
0.11 score on a scale
Standard Error 0.20
Media Parenting Practices (Observed)
Change in mobile device present during mealtime from T3 to T1
0.00 score on a scale
Standard Error 0.11
0.29 score on a scale
Standard Error 0.18
Media Parenting Practices (Observed)
Change in other media present during mealtime from T2 to T1
-0.17 score on a scale
Standard Error 0.08
0.22 score on a scale
Standard Error 0.13
Media Parenting Practices (Observed)
Change in other media present during mealtime from T3 to T1
-0.22 score on a scale
Standard Error 0.09
0.0 score on a scale
Standard Error 0.14

SECONDARY outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: One caregiver submitted family mealtime observations per family.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=11 Participants
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.
Wait List Control
n=7 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Parent Feeding Practices (Observed)
Change in TA score during mealtime from T2 to T1
0.09 score on a scale
Standard Error 0.07
-0.33 score on a scale
Standard Error 0.12
Parent Feeding Practices (Observed)
Change in TA score during mealtime from T3 to T1
0.11 score on a scale
Standard Error 0.08
0.14 score on a scale
Standard Error 0.13
Parent Feeding Practices (Observed)
Change in BC score during mealtime from T2 to T1
0.13 score on a scale
Standard Error 0.10
-0.11 score on a scale
Standard Error 0.17
Parent Feeding Practices (Observed)
Change in BC score during mealtime from T3 to T1
0.11 score on a scale
Standard Error 0.08
0.14 score on a scale
Standard Error 0.13

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Disruptive Behaviors (Parent Report)
Change in ECBI intensity t-score from T2 to T1
-8.95 T-score
Standard Error 1.25
0.55 T-score
Standard Error 1.77
Child Disruptive Behaviors (Parent Report)
Change in ECBI intensity t-score from T3 to T1
-8.74 T-score
Standard Error 1.40
-1.11 T-score
Standard Error 2.04

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

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.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=21 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Psychological Functioning (Parent Report)
Change in internalizing symptoms from T2 to T1
-9.48 T-score
Standard Error 1.54
-2.55 T-score
Standard Error 2.13
Child Psychological Functioning (Parent Report)
Change in internalizing symptoms from T3 to T1
-8.58 T-score
Standard Error 2.02
-2.00 T-score
Standard Error 2.93
Child Psychological Functioning (Parent Report)
Change in adaptive skills from T2 to T1
-10.2 T-score
Standard Error 4.12
-3.73 T-score
Standard Error 5.56
Child Psychological Functioning (Parent Report)
Change in adaptive skills from T3 to T1
-13.79 T-score
Standard Error 5.01
-10.22 T-score
Standard Error 7.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes.

Outcome measures

Outcome measures
Measure
PCIT-Health
n=22 Participants
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.
Wait List Control
n=11 Participants
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
Child Psychosocial Strengths (Parent Report)
Change in PSICA intensity from T2 to T1
30.39 score on a scale
Standard Error 4.16
-5.39 score on a scale
Standard Error 5.89
Child Psychosocial Strengths (Parent Report)
Change in PSICA intensity from T3 to T1
28.12 score on a scale
Standard Error 4.33
6.35 score on a scale
Standard Error 6.29

Adverse Events

PCIT-Health

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Wait List Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Domoff, PhD

Central Michigan University

Phone: 989-774-6461

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place