Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Martine W. F. T. Verhees, Eva Ceulemans, Marian J. Bakermans-Kranenburg, Marinus H. van IJzendoorn, Simon de Winter, Guy Bosmans

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Lack of trust in parental support is a transdiagnostic risk factor for the development of psychological problems throughout the lifespan. Research suggests that children’s cognitive attachment representations and related information processing biases could be an important target for interventions aiming to build trust in the parent-child relationship. A paradigm that can alter these biases and increase trust is that of Cognitive Bias Modification (CBM), during which a target processing bias is systematically trained. Trust-related CBM training effects could possibly be enhanced by oxytocin, a neuropeptide that has been proposed to play an important role in social information processing and social relationships. The present article describes the study protocol for a double-blind randomized controlled trial (RCT) aimed at testing the individual and combined effects of CBM training and oxytocin administration on trust in maternal support.

Methods/design

One hundred children (aged 8–12 years) are randomly assigned to one of four intervention conditions. Participants inhale a nasal spray that either contains oxytocin (OT) or a placebo. Additionally, they receive either a CBM training aimed at positively modifying trust-related information processing bias or a neutral placebo training aimed to have no trust-related effects. Main and interaction effects of the interventions are assessed on three levels of trust-related outcome measures: trust-related interpretation bias; self-reported trust; and mother-child interactional behavior. Importantly, side-effects of a single administration of OT in middle childhood are monitored closely to provide further information on the safety of OT administration in this age group.

Discussion

The present RCT is the first study to combine CBM training with oxytocin to test for individual and combined effects on trust in mother. If effective, CBM training and oxytocin could be easily applicable and nonintrusive additions to interventions that target trust in the context of the parent-child relationship.

Trial registration

ClinicalTrials.gov, ID: NCT02737254. Registered on 23 March 2016.
Appendix
Available only for authorised users
Literature
1.
Bowlby J. Attachment and loss: vol. 1. Attachment. New York: Basic Books; 1969.
2.
Cassidy J, Shaver P. Handbook of attachment: theory, research and clinical applications. 2nd ed. New York: Guilford Press; 2008.
3.
Ainsworth MDS, Blehar MC, Waters E, Wall S. Patterns of attachment. Hillsdale: Erlbaum; 1978.
4.
Verhage ML, Schuengel C, Madigan S, Fearon RM, Oosterman M, Cassiba R, et al. Narrowing the transmission gap: a synthesis of three decades of research on intergenerational transmission of attachment. Psychol Bull. 2016;142:337–66.CrossRefPubMed
5.
Fearon RP, Bakermans‐Kranenburg MJ, Van IJzendoorn MH, Lapsley AM, Roisman GI. The significance of insecure attachment and disorganization in the development of children’s externalizing behavior: a meta‐analytic study. Child Dev. 2010;81:435–56.CrossRefPubMed
6.
Groh AM, Roisman GI, Van IJzendoorn MH, Bakermans‐Kranenburg MJ, Fearon R. The significance of insecure and disorganized attachment for children’s internalizing symptoms: a meta‐analytic study. Child Dev. 2012;83:591–610.PubMed
7.
Madigan S, Brumariu LE, Villani V, Atkinson L, Lyons-Ruth K. Representational and questionnaire measures of attachment: a meta-analysis of relations to child internalizing and externalizing problems. Psychol Bull. 2016;142:367–99.CrossRefPubMed
8.
DeKlyen M, Greenberg MT. Attachment and psychopathology in childhood. In: Cassidy J, Shaver PR, editors. Handbook of attachment: theory, research, and clinical applications. 2nd ed. New York: Guilford Press; 2008. p. 637–65.
9.
Egeland B. Attachment-based intervention and prevention programs for young children. In: Tremblay RE, Barr RG, Peters RD, editors. Encyclopedia on early childhood development. Montreal: Centre of Excellence for Early Childhood Development; 2004. p. 1–7.
10.
Bosmans G, Kerns KA. Attachment in middle childhood: progress and prospects. In: Bosmans G, Kerns KA, editors. Attachment in middle childhood: theoretical advances and new directions in an emerging field, New dir child adolesc dev, vol. 148. 2015. p. 1–14.
11.
Del Giudice M. Attachment in middle childhood: an evolutionary-developmental perspective. In: Bosmans G, Kerns KA, editors. Attachment in middle childhood: theoretical advances and new directions in an emerging field, New dir child adolesc dev, vol. 148. 2015. p. 15–30.
12.
Bakermans-Kranenburg MJ, Van IJzendoorn MH, Juffer F. Less is more: meta-analyses of sensitivity and attachment interventions in early childhood. Psychol Bull. 2003;129:195–215.CrossRefPubMed
13.
Dykas MJ, Cassidy J. Attachment and the processing of social information across the life span: theory and evidence. Psychol Bull. 2011;137:19–46.CrossRefPubMed
14.
Bosmans G, Braet C, Koster E, De Raedt R. Attachment security and attentional breadth toward the attachment figure in middle childhood. J Clin Child Adolesc. 2009;38:872–82.CrossRef
15.
De Winter S, Vandevivere E, Waters TEA, Braet C, Bosmans G. Lack of trust in maternal support is associated with negative interpretations of ambiguous maternal behavior. J Child Fam Stud. 2016;25:146–51.CrossRef
16.
Dujardin A, Bosmans G, Braet C, Goossens L. Attachment-related expectations and mother-referent memory bias in middle childhood. Scand J Psychol. 2014;55:296–302.CrossRefPubMed
17.
Lundahl B, Risser HJ, Lovejoy MC. A meta-analysis of parent training: moderators and follow-up effects. Clin Psychol Rev. 2006;26:86–104.CrossRefPubMed
18.
Kazdin AE. Conduct disorders in childhood and adolescence. 2nd ed. Thousand Oaks: Sage; 1995.CrossRef
19.
Ollendick TH, Greene RW, Austin KE, Fraire MG, Halldorsdottir T, Allen KB, et al. Parent management training and collaborative and proactive solutions: a randomized control trial for oppositional youth. J Clin Child Adolesc. 2016;45:591–604.CrossRef
20.
Mathews A, Mackintosh B. Induced emotional interpretation bias and anxiety. J Abnorm Psychol. 2000;109:602–15.CrossRefPubMed
21.
MacLeod C, Koster EH, Fox E. Whither cognitive bias modification research? Commentary on the special section articles. J Abnorm Psychol. 2009;118:89–99.CrossRefPubMed
22.
Hallion LS, Ruscio AM. A meta-analysis of the effect of cognitive bias modification on anxiety and depression. Psychol Bull. 2011;137:940–58.CrossRefPubMed
23.
De Winter S, Bosmans G, Salemink E. Exploring the causal effect of interpretation bias on attachment expectations. Child Dev. 2017;88:131–40.CrossRefPubMed
24.
Gordon I, Vander Wyk BC, Bennett RH, Cordeaux C, Lucas MV, Eilbott JA, et al. Oxytocin enhances brain function in children with autism. Proc Natl Acad Sci U S A. 2013;110:20953–8.CrossRefPubMedPubMedCentral
25.
Paloyelis Y, Doyle OM, Zelaya FO, Maltezos S, Williams SC, Fotopoulou A, Howard MA. A spatiotemporal profile of in vivo cerebral blood flow changes following intranasal oxytocin in humans. Biol Psychiat. 2014;79:693–705.CrossRefPubMed
26.
Riem MME, Van IJzendoorn MH, Tops M, Boksem MAS, Rombouts SARB, Bakermans-Kranenburg MJ. Oxytocin effects on complex brain networks are moderated by experiences of maternal love withdrawal. Eur Neuropsychopharm. 2013;23:1288–95.CrossRef
27.
Bakermans-Kranenburg MJ, Van IJzendoorn MH. Sniffing around oxytocin: review and meta-analyses of trials in healthy and clinical groups with implications for pharmacotherapy. Transl Psychiatry. 2013;3:e258.CrossRefPubMedPubMedCentral
28.
Quintana DS, Alvares GA, Hickie IB, Guastella AJ. Do delivery routes of intranasally administered oxytocin account for observed effects on social cognition and behavior? A two-level model. Neurosci Biobehav Rev. 2015;49:182–92.CrossRefPubMed
29.
Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005;435:673–6.CrossRefPubMed
30.
Buchheim A, Heinrichs M, George C, Pokorny D, Koops E, Henningsen P, et al. Oxytocin enhances the experience of attachment security. Psychoneuroendocrino. 2009;34:1417–22.CrossRef
31.
Dillen C, Bernaerts S, Berra E, Bosmans G, Steyaert J, Alaerts K. Effects of intranasal oxytocin on emotion recognition, social functioning and attachment scales. Vlaams congres kinder- en jeugdpsychiatrie en -psychotherapie. Brussels; Belgium: 2015.
32.
33.
Van IJzendoorn MH, Bakermans-Kranenburg MJ. A sniff of trust: meta-analysis of the effects of intranasal oxytocin administration on face recognition, trust to in-group, and trust to out-group. Psychoneuroendocrino. 2012;37:438–43.CrossRef
34.
Guastella AJ, MacLeod C. A critical review of the influence of oxytocin nasal spray on social cognition in humans: evidence and future directions. Horm Behav. 2012;61:410–8.CrossRefPubMed
35.
Owen SF, Tuncdemir SN, Bader PL, Tirko NN, Fishel G, Tsien RW. Oxytocin enhances hippocampal spike transmission by modulating fast-spiking interneurons. Nature. 2013;500:458–62.CrossRefPubMedPubMedCentral
36.
Dadds MR, MacDonald E, Cauchi A, Williams K, Levy F, Brennan J. Nasal oxytocin for social deficits in childhood autism: a randomized controlled trial. J Autism Dev Disord. 2014;44:521–31.CrossRefPubMed
37.
Guastella AJ, Einfeld SL, Gray KM, Rinehart NJ, Tonge BJ, Lambert TJ, Hickie IB. Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders. Biol Psychiat. 2010;67:692–4.CrossRefPubMed
38.
Guastella AJ, Gray KM, Rinehart NJ, Alvares GA, Tonge BJ, Hickie IB, et al. The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial. J Child Psychol Psyc. 2015;56:444–52.CrossRef
39.
Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A, et al. Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders. J Child Adol Psychop. 2013;23:123–7.CrossRef
40.
41.
Van IJzendoorn MH, Bakermans-Kranenburg MJ. The role of oxytocin in parenting and as augmentative pharmacotherapy; critical issues and bold conjectures. J Neuroendocrinol. 2015. doi: 10.​1111/​jne.​12355.
42.
Sannen J. De ontwikkeling en validering van het Middle Childhood Attachment Micro Observation system (MCAM). Belgium: KU Leuven; 2015.
43.
Roelandts L. Een micro-analytisch onderzoek naar interactiepatronen van moeders en lagere schoolkinderen. Belgium: KU Leuven; 2015.
44.
Bartz JA, Zaki J, Bolger N, Ochsner KN. Social effects of oxytocin in humans: context and person matter. Trends Cogn Sci. 2011;15:301–9.PubMed
45.
Bakermans-Kranenburg MJ, Van IJzendoorn MH, Riem MM, Tops M, Alink LR. Oxytocin decreases handgrip force in reaction to infant crying in females without harsh parenting experiences. Soc Cogn Affect Neur. 2011;7:951–7.CrossRef
46.
Bartz JA, Zaki J, Bolger N, Hollander E, Ludwig NN, Kolevzon A, Ochsner KN. Oxytocin selectively improves empathic accuracy. Psychol Sci. 2010;21:1426–8.CrossRefPubMed
47.
Meinlschmidt G, Heim C. Sensitivity to intranasal oxytocin in adult men with early parental separation. Biol Psychiat. 2007;61:1109–11.CrossRefPubMed
48.
Pahlke F, König IR, Ziegler A. Randomization In Treatment Arms (RITA): ein Randomisierungs-Programm für klinische Studien. Informatik Biometrie Epidemiol Med Biol. 2004;35:1–22.
49.
Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005;20:187–91.CrossRefPubMed
50.
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, et al. SPIRIT 2013 Explanation and Elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
51.
Van IJzendoorn MH, Bhandari R, Van der Veen R, Grewen KM, Bakermans-Kranenburg MJ. Elevated salivary levels of oxytocin persist more than 7 h after intranasal administration. Front Neurosci. 2012;6:174.PubMedPubMedCentral
52.
53.
MacDonald E, Dadds MR, Brennan JL, Williams K, Levy F, Cauchi AJ. A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. Psychoneuroendocrino. 2011;36:1114–26.CrossRef
54.
Guastella AJ, Hickie IB, McGuinness MM, Otis M, Woods EA, Disinger HM, et al. Recommendations for the standardisation of oxytocin nasal administration and guidelines for its reporting in human research. Psychoneuroendocrino. 2013;38:612–25.CrossRef
55.
Vandevivere E, Braet C, Bosmans G. Under which conditions do early adolescents need maternal support? J Early Adolescence. 2015;35:162–9.CrossRef
56.
Salemink E, Van den Hout M. Validation of the “recognition task” used in the training of interpretation biases. J Behav Ther Exp Psy. 2010;41:140–4.CrossRef
57.
Ridenour TA, Greenberg MT, Cook ET. Structure and validity of people in my life: a self-report measure of attachment in late childhood. J Youth Adolescence. 2006;35:1037–53.CrossRef
58.
59.
Dujardin A, Santens T, Braet C, De Raedt R, Vos P, Maes B, Bosmans G. Middle childhood support-seeking behavior during stress: links with self-reported attachment and future depressive symptoms. Child Dev. 2016;87:326–40.CrossRefPubMed
60.
Biringen Z, Robinson JL, Emde RN. Manual for scoring the emotional availability scales. Fort Collins: Colorado State University; 1998.
61.
Dowdy E, Twyford J, Sharkey JD. Methods of assessing behavior: observations and rating scales. In: Saklofske DH, Reynolds CR, Schwean V, editors. The Oxford handbook of child psychological assessment. New York: Oxford University Press; 2013. p. 623–50.
62.
Jaccard P. The distribution of the flora in the alpine zone. New Phytol. 1912;11:37–50.CrossRef
63.
Ellis LK, Rothbart MK. Revision of the Early Adolescent Temperament Questionnaire. Minneapolis: Biennial Meeting of the Society for Research in Child Development; 2001.
64.
Ellis LK. Individual differences and adolescent psychosocial development. University of Oregon; 2002.
65.
Achenbach TM. Manual for the Child Behavior Checklist/4–18 and 1991 profile. Burlington: University of Vermont; 1991.
66.
Verhulst FC, Van der Ende J, Koot HM. Handleiding voor de CBCL/4-18 [Manual for the CBCL/4–18]. Rotterdam: Erasmus University; 1996.
67.
De Groot A, Koot HM, Verhulst FC. Cross-cultural generalizability of the Child Behavior Checklist cross-informant syndromes. Psychol Assessment. 1994;6:225–30.CrossRef
68.
Van Leeuwen K, Vermulst A. Handleiding bij de Verkorte Schaal voor Ouderlijk Gedrag [Manual of the short version of the Parental Behavior Scale]. Leuven: KU Leuven; 2010.
69.
Delhaye M, Beyers W, Klimstra TA, Linkowski P, Goossens L. The Leuven Adolescent Perceived Parenting Scale (LAPPS): reliability and validity with French-speaking adolescents in Belgium. Psychol Belg. 2012;52:289–305.CrossRef
70.
Grolnick WS, Ryan RM, Deci EL. Inner resources for school achievement: motivational mediators of children's perceptions of their parents. J Educ Psychol. 1991;83:508–17.CrossRef
71.
Barber BK. Parental psychological control: revisiting a neglected construct. Child Dev. 1996;67:3296–319.CrossRefPubMed
72.
Beyers W, Goossens L. Dynamics of perceived parenting and identity formation in late adolescence. J Adolescence. 2008;31:165–84.CrossRef
73.
Kins E, Beyers W, Soenens B, Vansteenkiste M. Patterns of home leaving and subjective well-being in emerging adulthood: the role of motivational processes and parental autonomy support. Dev Psychol. 2009;45:1416–29.CrossRefPubMed
74.
Janssens A, Goossens L, Van Den Noortgate W, Colpin H, Verschueren K, Van Leeuwen K. Parents’ and adolescents’ perspectives on parenting: evaluating conceptual structure, measurement invariance and criterion validity. Assessment. 2015;22:473–89.CrossRefPubMed
75.
Petersen AC, Crockett L, Richards M, Boxer A. A self-report measure of pubertal status: reliability, validity, and initial norms. J Youth Adolescence. 1988;17:117–33.CrossRef
76.
Carskadon MA, Acebo C. A self-administered rating scale for pubertal development. J Adolescent Health. 1993;14:190–5.CrossRef
77.
78.
Piccirillo JF, Merritt MG, Richards ML. Psychometric and clinimetric validity of the 20-item Sino-Nasal Outcome Test (Snot-20). Otolaryng Head Neck. 2002;126:41–7.CrossRef
79.
De Winter S. Middle childhood attachment from a cognitive perspective: the role of interpretation processing biases (Doctoral dissertation). 2017. Retrieved from https://​lirias.​kuleuven.​be/​. Retrieved May 23 2017
80.
Faul F, Erdfelder E, Lang A, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39:175–91.CrossRefPubMed
81.
Uvnäs Moberg K, Prime DK. Oxytocin effects in mothers and infants during breastfeeding. Infant. 2013;9:201–6.
Metadata
Title
The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial
Authors
Martine W. F. T. Verhees
Eva Ceulemans
Marian J. Bakermans-Kranenburg
Marinus H. van IJzendoorn
Simon de Winter
Guy Bosmans
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2077-2

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial

Study protocol

Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial

Study protocol

A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol

Study protocol

The effects of green cardamom on blood glucose indices, lipids, inflammatory factors, paraxonase-1, sirtuin-1, and irisin in patients with nonalcoholic fatty liver disease and obesity: study protocol for a randomized controlled trial

Study protocol

Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial

Study protocol

Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial