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Table 1 Questionnaires and items employed at the different study assessments

From: Save the children by treating their mothers (PriVileG-M-study) - study protocol: a sequentially randomized controlled trial of individualized psychotherapy and telemedicine to reduce mental stress in pregnant women and young mothers and to improve Child’s health

Study Assessments

Measures

Study time points

S1

S2

BLa

0W

8W

26W

52 W

Socio-demographic

Date of birth of the mother

X

      

Date of birth of the infant

X

      

Week of gestation

X

X

X

    

Educational attainment

X

 

X

    

Marital status

X

 

X

    

Indigenous status

  

X

    

Profession

  

X

    

Medical

 Physical health of the mother

Medical documentation of the mother from the German Mutterpass

   

X

   

Alcohol, Smoking and other Lifestyle habits, chronic diseases, pregnancy related diseases

  

X

X

X

X

X

Documentation of medication using Brown bag review

  

X

    

 Physical health of the infant

Child’s medical records, the Geman U-Untersuchungs-Heft filled in by pediatrician

    

X

X

X

Semi structured health interview including number of infectious diseases, chronic disease use of antibiotics.

    

X

X

X

Brown bag review for medication

    

X

X

X

Anthropometric measures including length, weight, and head circumference

    

X

X

X

physical examination of the infant

    

X

X

 

 Infant General Development

Neuropsychologic Development Screening (NES)

    

X

X

X

 Infant behavior

German questionnaire about crying, feeding and sleeping behavior (SFS)

    

X

X

 

Infant Behavior Questionnaire (IBQ-R)

    

X

X

X

 Breastfeeding Rate

Questionnaire about breastfeeding rates and times

    

X

X

X

Psychological

 Stress Symptoms

Brief Symptom Inventory (BSI-18)

X

X

X

 

X

X

X

Coping Inventory for Stressful Situations (CISS)

  

X

   

X

questionnaire about chronic stress (TICS)

  

X

   

X

Recognition of stress-factors (KFB)

  

X

 

X

X

X

 Resilience

RS-11

  

X

 

X

X

X

Mental Health

 Mental Disorders

Diagnostic Interview for Mental Disorders (DIPS)

 

X

     

 Trauma

Childhood Trauma Questionnaire (CTQ)

  

X

    

 Dissociation

Dissociative Experiences Scale-Taxon (DES-T)

  

X

  

X

X

 Depression

Patient Health Questionnaire (PHQ-9)

  

X

 

X

X

X

Edinburgh Postnatal Depression Scale (EPDS)

  

X

X

X

X

X

 Worries

Penn State Worry Questionnaire (PSWQ)

  

X

 

X

X

X

Cambridge Worry Scale (CWS)

  

X

    

 Personality Traits

NEO-FFI

  

X

   

X

 Social network

short partnership questionnaire (PFB-K)

  

X

    

Perceived Social Support Questionnaire (F-SozU-6)

  

X

 

X

X

X

 Attachment in adults

Experiences in Close Relationships - Revised (ECR−RD 12)

  

X

    

Revised Adult Attachment Scale (AAS-R)

  

X

    

 Prenatal attachment

Maternal Antenatal Attachment Scale (MAAS)

  

X

    

 Postpartum attachment

Postpartum Bonding Questionnaire (PBQ)

    

X

X

X

Video assessments

 Attachment

Mother-child interaction

    

X

X

 

Ecological Momentary Assessment

 Mental state

Multidimensional Mood Questionnaire (MDMQ)

  

X

  

X

X

stress level

  

X

  

X

X

 Physical health

self-related health of the mother

  

X

  

X

X

Of the infant

     

X

X

 Mother-child-interaction

Modified items of the PBQ

     

X

X

Modified item of the self-assessment questionnaire about mother-child-interaction (SF-MKI)

     

X

X

 Mother-child-bonding

Modified items of the MAAS

  

X

  

X

X

 Child sleeping behavior

Modified items of the regulation disorders questionnaire (SFS)

     

X

X

Laboratory

 Saliva Cortisol Mother and Infant

At midday collection during visit

  

X

 

X

X

 

Morning and evening Saliva cortisol from 3 different days

    

X

X

 

 Saliva Melatonin

Saliva melatonin at midday during the visit

  

X

 

X

X

 

Morning and evening Saliva Melatonin from 3 different days

    

X

X

 

 Urin sample Mother and Infant

Analysis of metabolics and oxytocin

  

X

 

X

X

 

 Bloodsample of the mother

Full blood analysis including complete blood count, electrolytes, glucose, kidney function, liver, thyroid and inflammatory values

  

X

  

X

 

Mothers Epigenetics

  

X

  

X

 

 Cordblood

Infants Epigenetics

   

X

   

 Colostrum

Composition of Colostrum, Peptidom

   

X

   

 Breast milk

Composition of Mothermilk, Peptidom

    

X

X

 

Evaluative Assessments

 Qualitative interviews

Structured individual interviews about the contentment of the treatment result, perceived benefits and changes

    

X

X

X

 Quantitative questionnaires

expectations in the study

  

X

   

X

perceived benefits of the study and the quality of the interventions

    

X

X

X

impact of the telemedical intervention on quality of life

      

X

study evaluation

      

X

Documentation

 Therapeutic processa

date, time, home visit or not, woman appeared or not, treatment focus, course of content, changes since the last consultation, agreements and homeworks, interactions, hypotheses, discussed topics, therapeutical interventions

  

 

 Telemedical processa

date, time of day, duration of the call, circumstances of the call

      

  1. Note: S1 = Screening1, S2 = Screening2, BL = Baseline (occurs at approximately 25-28 weeks gestation), 0W = delivery, 8W = 8-weeks-follow-up, 26W = 26-weeks-follow-up, 52W = 52-weeks-follow-up, adocumentation of the treatment process (therapeutical and telemedical) do not occur at follow-ups, but over the period of the treatment at each consultation