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Completed

NCT Number: NCT04622969

The Healthy Child Development Program Study

This study conducts a preliminary test of an intervention program delivered in the home to assist families of preschool-age children with social, emotional, and behavioral development, and the acquisition of healthy lifestyle behaviors.

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Key information

Conditions

Child Behavior Behavior Child Health Child, Preschool Parents

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29204, United States

About this study

Utilizing referrals from community-based organizations serving high-risk families, this study addresses both health and behavioral domains through a family-based intervention. The home-delivered prevention intervention includes content on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices. Families engage in practical skill building and have the opportunity to practice these skills and receive feedback.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • parent has primary custody of the child
  • one or more children in the home is in the 3 to 4 year old age range
  • English-speaking parent
  • parent stated an interest to participate in the program
  • parent completes informed consent process
  • family experiencing economic disadvantage
  • parenting challenges due to child behavior

Exclusion criteria

  • an open Child Protective Services maltreatment case on the family
  • parent receiving inpatient treatment or enrolled in an institutional-residential treatment program

Treatment and study plan

Healthy Child Development Program

Behavioral

The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.

Primary outcomes

  1. Child Behavior Problems

    Time frame: baseline, pre-intervention

    Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.

  2. Child Behavior Problems

    Time frame: six months after baseline assessment

    Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.

  3. Child Physical Activity

    Time frame: baseline, pre-intervention

    Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.

  4. Child Physical Activity

    Time frame: six months after baseline assessment

    Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.

  5. Child Screen Time

    Time frame: baseline, pre-intervention

    Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.

  6. Child Screen Time

    Time frame: six months after baseline assessment

    Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.

  7. Child Sleep Duration

    Time frame: baseline, pre-intervention

    Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.

  8. Child Sleep Duration

    Time frame: six months after baseline assessment

    Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.

Secondary outcomes

  1. Parenting Difficulties

    Time frame: baseline, pre-intervention

    Parenting difficulties refers to the Parenting Scale Total Score. The total score is the average of 30 items, with a minimum value of 1.0 and a maximum value of 7.0. Higher scores mean a worse outcome (i.e., greater parenting difficulties).

  2. Parenting Difficulties

    Time frame: six months after baseline assessment

    Parenting difficulties refers to the Parenting Scale Total Score. The total score is the average of 30 items, with a minimum value of 1.0 and a maximum value of 7.0. Higher scores mean a worse outcome (i.e., greater parenting difficulties).

  3. Parental Stress

    Time frame: baseline, pre-intervention

    Parental stress refers to the Parenting Daily Hassles Scale, which is the total of 20 items. The minimum and maximum values are 0 and 80 respectively, with higher scores meaning a worse outcome (i.e., greater parental stress).

  4. Parental Stress

    Time frame: six months after baseline assessment

    Parental stress refers to the Parenting Daily Hassles Scale, which is the total of 20 items. The minimum and maximum values are 0 and 80 respectively, with higher scores meaning a worse outcome (i.e., greater parental stress).

  5. Parental Confidence

    Time frame: baseline, pre-intervention

    Parental confidence refers to the Parenting Sense of Competence scale. This scale, based on the sum of responses on 17 items, ranges from a minimum of 17 and a maximum of 102, with higher scores meaning a better outcome (i.e., greater parental confidence).

  6. Parental Confidence

    Time frame: six months after baseline assessment

    Parental confidence refers to the Parenting Sense of Competence scale. This scale, based on the sum of responses on 17 items, ranges from a minimum of 17 and a maximum of 102, with higher scores meaning a better outcome (i.e., greater parental confidence).

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Targeting Behavioral Adjustment and Healthy Lifestyle in Preschool-age Children Using an Integrated Family-Based Intervention

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 10, 2020
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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