Stamford Group Family Nurture Intervention

NCT ID: NCT03442439

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2018-11-25

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.

Conditions

Behavior Problem; Developmental Delay; Emotional Disturbances; Family Conflict

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Nutrition and Play Intervention (NPI)

Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.

Group Type: ACTIVE_COMPARATOR

Nutrition and Play Intervention

Intervention Type: BEHAVIORAL

Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.

Family Nurture Intervention (FNI)

Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.

Group Type: EXPERIMENTAL

Family Nurture Intervention

Intervention Type: BEHAVIORAL

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 though sustained physical contact; comfort touch, soothing words, and eye contact.

Interventions

Nutrition and Play Intervention

Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.

Intervention Type: 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 though sustained physical contact; comfort touch, soothing words, and eye contact.

Intervention Type: BEHAVIORAL

Other Intervention Names

NPI; FNI

Eligibility Criteria

Inclusion Criteria

• Child is a singleton
• Mother can speak, read and write in English or Spanish
• Child is between the ages of 2-4 1/2 years at date of enrollment
• Mother is 18 years of age or older at the time of consent
• Child resides with mother
• Child demonstrates developmental deficit as measured by the Strengths and Difficulties Questionnaire (13 or higher on behavioral questions or 4 or less on prosocial questions)
• Mother and child deemed "emotionally unconnected" using the Welch Emotional Connection Scale (WECS) to score their five minute Welch Lap Test video
• Mother is able to commit to study schedule

Exclusion Criteria

• The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral palsy
• Child has a motor disability
• Mother sees or hears things that other people do not seem to see or hear
• Mother has trouble distinguishing whether something is real or part of imagination or dreams
• Mother is currently taking antipsychotic medications
• Mother or child have any medical conditions that might prevent them from participating in block play, mother holding child, or child sitting on mother's lap
• Mother has any current drug and/or alcohol abuse
• Mother is more than 4 months pregnant
• Mother is currently involved with Department of Children and Families
• The child has a diagnosis of Autism

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 54 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Martha G. Welch, MD

Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha G Welch, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Stamford Childrens Learning Center

Stamford, Connecticut, United States

Countries

United States

Other Identifiers

AAAR5518

Identifier Type: -

Identifier Source: org_study_id