Trial of Home Visitation Among Infants With Failure To Thrive
Condition: Failure to Thrive
MeSH terms: Failure to Thrive
Study type: Interventional

Summary: 
      1. Children in the home intervention group will have better growth (increase in weight and
           height) than children in the control group.

        2. Children in the home intervention group will have better behavior than children in the
           control group.

        3. Children in the home intervention group will have better academic performance than
           children in the control group.
    

Detailed description: 
      During the first years of life when energy needs are high, growth serves as an objective
      measure of children's well-being. Failure-to-thrive (FTT) occurs when infants' rate of weight
      gain is below expectations based on age and gender-specific growth charts. The proposed
      randomized controlled trial evaluates whether a home-based intervention delivered by
      community health workers is effective in altering patterns of children's growth and
      development.

      Infants were recruited from pediatric primary care clinics serving low-income, urban
      communities from 1988 through 1993. Eligibility criteria included age < 25 months, at least
      35 weeks gestational age and appropriate birth weight for gestational age, and no congenital
      problems, disabilities, or chronic illnesses.

      Children in the FTT group had to meet one of two criteria using age and gender-specific
      National Center for Health Statistics (NCHS) growth charts: sustained weight-for-age below
      the 5th percentile, weight-for-length below the 10th percentile or weight for age crossing
      two major centiles and falling below the 25th percentile. All infants were examined by a
      pediatrician, who also reviewed their medical charts to ensure that they met criteria for FTT
      and there were no known syndromes or obvious major organ system dysfunctions, such as
      congenital heart disease, to account for the growth failure of the infants in the FTT group.

      Caregivers were invited to participate in a longitudinal research project, using consent
      procedures approved by the Institutional Review Board of the University of Maryland,
      Baltimore. Over 90% of eligible caregivers agreed and participated in an initial evaluation
      that included measures of growth, standardized developmental assessments, and a 60-minute
      interview of questionnaires on demographics, children's behavior, and maternal and family
      functioning. Developmental assessments were administered by psychology graduate students,
      supervised by a pediatric psychologist. A home visit was scheduled within two weeks of the
      initial evaluation.

      Children with FTT were treated in an interdisciplinary clinic. Based on a randomization
      procedure, stratified by race, gender, and infant age to ensure equivalence across groups,
      children with FTT were randomized to receive either the clinical intervention plus home
      intervention (FTT-HI) or the clinical intervention only (FTT-CO).

      The intervention was based on ecological theory and included a therapeutic alliance between
      the interventionist and the caregiver; support to the caregiver's personal, family, and
      environmental needs; opportunities to model and promote responsive parent-infant interaction;
      and problem-solving strategies regarding personal, parenting, and children's issues. The
      Hawaii Early Learning Program was used as a curriculum guide.

      The intervention was delivered by three, part-time lay home visitors employed by a
      community-based agency specializing in early intervention. The home visitors received an
      eight-session training program and were supervised by a community health nurse. The home
      visitors had portable mats and toys to demonstrate developmentally appropriate activities and
      to facilitate parent-child interaction. They did not focus on nutrition or feeding behavior
      and they did not weigh the children. One-hour visits were scheduled weekly for one year; the
      number of visits varied from 0 to 47.

      The children and caregivers return for regularly scheduled evaluations throughout the child's
      life. Evaluators are unaware of their growth or intervention status. Caregivers provide the
      name of the children's school and requests are sent for information on classroom behavior.
      Families and teachers are compensated for participating in evaluations.

      The outcome measures are growth, cognition, academic performance, and social behavior.
      Evaluators are unaware of the children's growth history or group assignment. Standardized
      measures are used.
    

Intervention name(s): Home Visit
Intervention type(s): Behavioral
Intervention description(s): Homw visits scheduled weekly for one year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Intervention; Home Visit; Growth; Child Development