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NCT ID: NCT03481452

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-12-31

Brief Summary

The present study aimed to determine whether infants disorders of regulation of states are associated with perinatal anxiety, and further to explore the efficacy of the behavioral intervention in enhancing positive interactions between mothers and their infants and thus ameliorating infants' disorders of regulation of states.

Detailed Description

The subjects were recruited from the hospitalized pregnant women waiting for delivery from the department of gynecology and obstetrics of the first affiliated hospital of Xi'an Jiaotong university. A total of 200 perinatal anxiety women were divided to two group(behavioral intervention group and control group) according to mental health assessment. Inclusion criteria were applied: 1. mother aged 18-40 years; 2. First-time mother, full-term and singleton pregnancy; 3.the Hamilton Anxiety Scale(HAMA) score ≥14; 4.birth with no intrapartum complications; and 5. Apgar score > 8 at the first, fifth, and tenth minutes after birth. Exclusion criteria were as follows: any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke,atrial fibrillation, peripheral arterial disease, and other severe diseases.Preterm infants (< 37 weeks gestation) and multiple births were excluded from the current analysis. All the subjects completed the infants behavior and regulation of states assessment by the NBAS and were followed to 8 weeks postpartum. Mother-newborn pairs were randomly divided into NBO intervention group and control group. NBO intervention was performed once a week until 2 months. 2 ml peripheral blood was collected in the pregnant woman before delivery and in the newborns within 3 days postpartum.The serum fraction was removed after centrifugation and stored at -20°C. Levels of serum cortisol in mothers and newborns were determined using Chemiluminescence analysis (CLIA) and a radio immunoassay. All sample analyses were performed by the first affiliated hospital of Xi'an Jiaotong university chemistry laboratory. Laboratory personnel were blinded to mother and infant outcomes.

Conditions

Behavior; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

psychotherapy intervention group

NBO behavioral intervention would be used to improve mother-infant dyad interaction and infants' disorders of regulation of states.

Group Type: EXPERIMENTAL

psychotherapy

Intervention Type: BEHAVIORAL

NBO is an infant-focused, family relationship-based intervention measure, which aims to exhibit to parents infants' surprised ability, understand infants' strength and aspects needed to be improved, strength parents' parenting confidence, and promote sound development of infant-mother relationship.

control group

No behavioral intervention would be used.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

psychotherapy

NBO is an infant-focused, family relationship-based intervention measure, which aims to exhibit to parents infants' surprised ability, understand infants' strength and aspects needed to be improved, strength parents' parenting confidence, and promote sound development of infant-mother relationship.

Intervention Type: BEHAVIORAL

Other Intervention Names

Neonatal Behavioral Observation (NBO)

Eligibility Criteria

Inclusion Criteria

• mother aged 18-40 years;
• first-time mother, full-term and singleton pregnancy;
• the Hamilton Anxiety Scale(HAMA) score ≥14;
• the birth with no intrapartum complications;
• Apgar score > 8 at the first, fifth, and tenth minutes after birth.

Exclusion Criteria

• any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke, atrial fibrillation, peripheral arterial disease, and other severe diseases;
• preterm infants (< 37 weeks gestation);
• multiple births;
• infants with congenital anomalies, signs of illness, or high-risk factors.

• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xian Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Li, PhD, MD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Hui Li, PhD, MD

Role: CONTACT

huili@mail.xjtu.edu.cn

+86 18991232133

zhongliang Zhu, PhD

Role: CONTACT

zlzhu@mail.xjtu.edu.cn

+86 13991289992

Facility Contacts

Hui Li, PhD, MD

Role: primary

huili@mail.xjtu.edu.cn

+86 18991232133

Other Identifiers

XCH-PRENATALSTRESS-001

Identifier Type: OTHER

Identifier Source: secondary_id

XJTU-PRENATALSTRESS-001

Identifier Type: -

Identifier Source: org_study_id