Family Nurture Intervention, A Group Model in Connecticut

NCT ID: NCT02970565

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-05-31

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; Development Delay; Emotional Disturbance; Family Conflict

Study Design

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

Study Groups

Nutrition and Play Intervention

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

Group Type: EXPERIMENTAL

Nutrition and Play Intervention

Intervention Type: BEHAVIORAL

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

Family Nurture Intervention

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 through sustained physical contact, comfort touch, soothing words, and eye contact.

Interventions

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.

Intervention Type: BEHAVIORAL

Nutrition and Play Intervention

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

Intervention Type: BEHAVIORAL

Other Intervention Names

FNI; NPI

Eligibility Criteria

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

• 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

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

Norwalk Housing Authority

Cos Cob, Connecticut, United States

Countries

United States

References

Welch MG, Ludwig RJ, Hane AA, Austin J, Markowitz ES, Jaffe ME, Myers MM. Preschool-based mother-child emotional preparation program improves emotional connection, behavior regulation in the home and classroom: a randomized controlled trial. Front Child Adolesc Psychiatry. 2023 Oct 20;2:1232515. doi: 10.3389/frcha.2023.1232515. eCollection 2023.

Reference Type: DERIVED

PMID: 39816857 (View on PubMed)

Other Identifiers

AAAQ9547

Identifier Type: -

Identifier Source: org_study_id