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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 AssessmentsMeasuresStudy time points
S1S2BLa0W8W26W52 W
Socio-demographicDate of birth of the motherX      
Date of birth of the infantX      
Week of gestationXXX    
Educational attainmentX X    
Marital statusX X    
Indigenous status  X    
Profession  X    
Medical
 Physical health of the motherMedical documentation of the mother from the German Mutterpass   X   
Alcohol, Smoking and other Lifestyle habits, chronic diseases, pregnancy related diseases  XXXXX
Documentation of medication using Brown bag review  X    
 Physical health of the infantChild’s medical records, the Geman U-Untersuchungs-Heft filled in by pediatrician    XXX
Semi structured health interview including number of infectious diseases, chronic disease use of antibiotics.    XXX
Brown bag review for medication    XXX
Anthropometric measures including length, weight, and head circumference    XXX
physical examination of the infant    XX 
 Infant General DevelopmentNeuropsychologic Development Screening (NES)    XXX
 Infant behaviorGerman questionnaire about crying, feeding and sleeping behavior (SFS)    XX 
Infant Behavior Questionnaire (IBQ-R)    XXX
 Breastfeeding RateQuestionnaire about breastfeeding rates and times    XXX
Psychological
 Stress SymptomsBrief Symptom Inventory (BSI-18)XXX XXX
Coping Inventory for Stressful Situations (CISS)  X   X
questionnaire about chronic stress (TICS)  X   X
Recognition of stress-factors (KFB)  X XXX
 ResilienceRS-11  X XXX
Mental Health
 Mental DisordersDiagnostic Interview for Mental Disorders (DIPS) X     
 TraumaChildhood Trauma Questionnaire (CTQ)  X    
 DissociationDissociative Experiences Scale-Taxon (DES-T)  X  XX
 DepressionPatient Health Questionnaire (PHQ-9)  X XXX
Edinburgh Postnatal Depression Scale (EPDS)  XXXXX
 WorriesPenn State Worry Questionnaire (PSWQ)  X XXX
Cambridge Worry Scale (CWS)  X    
 Personality TraitsNEO-FFI  X   X
 Social networkshort partnership questionnaire (PFB-K)  X    
Perceived Social Support Questionnaire (F-SozU-6)  X XXX
 Attachment in adultsExperiences in Close Relationships - Revised (ECR−RD 12)  X    
Revised Adult Attachment Scale (AAS-R)  X    
 Prenatal attachmentMaternal Antenatal Attachment Scale (MAAS)  X    
 Postpartum attachmentPostpartum Bonding Questionnaire (PBQ)    XXX
Video assessments
 AttachmentMother-child interaction    XX 
Ecological Momentary Assessment
 Mental stateMultidimensional Mood Questionnaire (MDMQ)  X  XX
stress level  X  XX
 Physical healthself-related health of the mother  X  XX
Of the infant     XX
 Mother-child-interactionModified items of the PBQ     XX
Modified item of the self-assessment questionnaire about mother-child-interaction (SF-MKI)     XX
 Mother-child-bondingModified items of the MAAS  X  XX
 Child sleeping behaviorModified items of the regulation disorders questionnaire (SFS)     XX
Laboratory
 Saliva Cortisol Mother and InfantAt midday collection during visit  X XX 
Morning and evening Saliva cortisol from 3 different days    XX 
 Saliva MelatoninSaliva melatonin at midday during the visit  X XX 
Morning and evening Saliva Melatonin from 3 different days    XX 
 Urin sample Mother and InfantAnalysis of metabolics and oxytocin  X XX 
 Bloodsample of the motherFull blood analysis including complete blood count, electrolytes, glucose, kidney function, liver, thyroid and inflammatory values  X  X 
Mothers Epigenetics  X  X 
 CordbloodInfants Epigenetics   X   
 ColostrumComposition of Colostrum, Peptidom   X   
 Breast milkComposition of Mothermilk, Peptidom    XX 
Evaluative Assessments
 Qualitative interviewsStructured individual interviews about the contentment of the treatment result, perceived benefits and changes    XXX
 Quantitative questionnairesexpectations in the study  X   X
perceived benefits of the study and the quality of the interventions    XXX
impact of the telemedical intervention on quality of life      X
study evaluation      X
Documentation
 Therapeutic processadate, 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 processadate, 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