An interventional study of Family Nurture Intervention and Nutrition and Play Intervention in Behavior Problem, Development Delay and Emotional Disturbance, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 24 Months to 54 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
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.
517 studies on the registry are indexed under Problem Behavior; 92 are open to participants now.
This study's enrollment of 106 is above the median of 90 across 391 interventional studies indexed under Problem Behavior.
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Exclusion Criteria:
Mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.
Behavioral: Nutrition and Play Intervention
Mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
Behavioral: Family Nurture Intervention
The mother-child pair will be asked to talk and play with each other as they customarily do. If the child becomes restless and dysregulated the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comfort touch, soothing words, and eye contact.
Also known as: FNI
Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.
Also known as: NPI
Change in Childhood Behavior Checklist (CBCL) Score
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.
Time frame: Baseline, 6 months
Co-regulation of Vagal Tone
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.
Time frame: Up to 12 months
Change in Maternal Anxiety and Depressive Symptoms
Mothers will complete various questionnaires measuring their mood and state.
Time frame: Up to 12 months
Changes in Welch Emotional Connection Scale
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.
Time frame: Up to 12 months
Plan to share: No
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Columbia University