Clinical trial NCT04622969: The Healthy Child Development Program Study
Official title: Targeting Behavioral Adjustment and Healthy Lifestyle in Preschool-age Children Using an Integrated Family-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Child Health
Child, Preschool
Parents
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Behavior Problems
timeFrame: baseline, pre-intervention
measure: Child Behavior Problems
timeFrame: six months after baseline assessment
measure: Child Physical Activity
timeFrame: baseline, pre-intervention
measure: Child Physical Activity
timeFrame: six months after baseline assessment
measure: Child Screen Time
timeFrame: baseline, pre-intervention
measure: Child Screen Time
timeFrame: six months after baseline assessment
measure: Child Sleep Duration
timeFrame: baseline, pre-intervention
measure: Child Sleep Duration
timeFrame: six months after baseline assessment
Secondary outcomes:
measure: Parenting Difficulties
timeFrame: baseline, pre-intervention
measure: Parenting Difficulties
timeFrame: six months after baseline assessment
measure: Parental Stress
timeFrame: baseline, pre-intervention
measure: Parental Stress
timeFrame: six months after baseline assessment
measure: Parental Confidence
timeFrame: baseline, pre-intervention
measure: Parental Confidence
timeFrame: six months after baseline assessment
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Kristen D Seay, Ph.D., MSW
role: PRINCIPAL_INVESTIGATOR
References: