Family Nurture Intervention, A Group Model in Connecticut

Not Applicable

Completed

Conditions: Behavior Problem
Development Delay
Emotional Disturbance
Family Conflict

Interventions: Behavioral: Family Nurture Intervention
Behavioral: Nutrition and Play Intervention

Brief Summary: The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.

Detailed Description: There are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. Although improvements in behavior have resulted from these interventions, they are limited in numerous ways. They are usually time-consuming, both for the child and the teacher or clinician providing the intervention. In order to see an effect of the intervention, most children must engage in the intervention procedure for several years. Moreover, the effects of most current intervention procedures are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.

Recruitment & Eligibility

Inclusion Criteria

Child is a singleton
Mother can speak in English or Spanish
Child is between the ages of 2 to 4 ½ years at date of enrollment
Mother is 18 years of age or older at the time of consent
Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more on the total score excluding the pro-social questions; OR 4 or less on the pro-social questions, which are reverse scored i.e. higher is better)
Child must reside with mother

Exclusion Criteria

The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
The child has a diagnosis of Autism
The child has severe motor or physical disability
Mother currently presents with psychosis or is currently taking antipsychotic medication
Current maternal drug and/or alcohol abuse
Mother has any current involvement with Child Protective Services (Department of Children and Families)
Mother is pregnant
Mother and/or infant has a medical condition or contagion that precludes intervention components

Arm && Interventions

Group	Intervention	Description
Family Nurture Intervention	Family Nurture Intervention	Mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
Nutrition and Play Intervention	Nutrition and Play Intervention	Mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.

Primary Outcome Measures

Name	Time	Method
Change in Childhood Behavior Checklist (CBCL) Score	Baseline, 6 months	The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems.

Secondary Outcome Measures

Name	Time	Method
Co-regulation of Vagal Tone	Up to 12 months	Using ECG data obtained during each follow-up visit, the investigators will characterize various parameters of cardiac function and regulation including assessments of parasympathetic modulation of heart rate. Long term individual differences in attention and emotional regulation are correlated with these parameters. Heart rate and respiration obtained from analogue outputs from standard clinical monitors or from specially designed hardware utilized routinely in the studies of human infants. The digitized recordings of ECG and respiration will be processed using software designed specifically for displaying, marking, and analyzing data from these records.
Change in Maternal Anxiety and Depressive Symptoms	Up to 12 months	Mothers will complete various questionnaires measuring their mood and state.
Changes in Welch Emotional Connection Scale	Up to 12 months	This is a clinical tool to assess the emotional connectedness of a mother-child dyad. The aim of the WECS is to assess behaviors observed during mother-child interaction, and score these behavioral observations across four domains to better inform health professionals of a dyad's interventional need. This scale will be completed by study staff.

Locations (1): Norwalk Housing Authority
🇺🇸
Cos Cob, Connecticut, United States