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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     
 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
 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
 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
 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