Family Nurture Intervention, A Group Model in Connecticut

Columbia University

Status: Completed

Conditions: Behavior Problem; Development Delay; Emotional Disturbance; Family Conflict

Treatments: Behavioral: Nutrition and Play Intervention; Behavioral: Family Nurture Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02970565

AAAQ9547

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 24 to 54 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Nutrition and Play Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Nutrition and Play Intervention

Family Nurture Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Family Nurture Intervention