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Table 1 Schedule of enrollment, interventions and assessments in line with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)

From: The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial

 

Study period

Enrollment

Allocation

Post-allocation

Timepoint

Before intervention (baseline)

0

During intervention

Immediately after intervention

24 h after intervention

Enrollment:

 Eligibility screen

X

    

 Informed consent

X

    

 Allocation

 

X

   

Interventions:

 CBM training + OT

  

X

  

 CBM training + PL

  

X

  

 Neutral training + OT

  

X

  

 Neutral training + PL

  

X

  

Assessments:

 Interpretation speed of secure and insecure scenario resolutions

  

X

  

 Secure interpretation bias

X

  

X

 

 Insecure interpretation bias

X

  

X

 

 Trust (PIML)

X

  

X

 

 Puzzle task

X

  

X

 

 Mood

X

 

X

X

 

 OT side-effects

   

X

X

Mother-reported questionnaires:

 Demographic questionnaire

  

X

  

 Child temperament (EATQ-R)

  

X

  

 Child behavioral and emotional problems (CBCL)

  

X

  

 Parenting questionnaires (VSOG, subscales LAPPS, POPS, PCS)

  

X

  

 Pubertal development (PDS)

  

X

  

 Symptoms of sino-nasal problems (Snot-20)

  

X

  
  1. CBCL Child Behavior Checklist, EATQ-R Early Adolescent Temperament Questionnaire-Revised, LAPPS Louvain Adolescent Perceived Parenting Scale, OT oxytocin, PCS Psychological Control Scale, PDS Pubertal Developmental Scale, PIML People In My Life, PL placebo, POPS Perceptions of Parents Scale, 20-Snot-20 20-item Sino-Nasal Outcome Test, VSOG Verkorte Schaal Ouderlijk Gedrag