A Randomized Controlled Trial on Brief Behavioral Parent Training

NCT05591820 | Recruiting

• 2 other identifiers: METc 2022/221file number 60-63600-98-1
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible. OBJECTIVES: This project aims to increase the effective use of parent training for children with behavioral difficulties by (1) examining short and longer-term effectiveness of a new, brief, individual, and individually-tailored parent training program with optional booster sessions to prevent relapse, compared to care as usual (CAU); (2) assessing the cost-effectiveness of the brief parent training program compared to CAU. STUDY DESIGN: In this two-arm, multi-center randomized controlled trial (RCT), parents are randomly assigned (1:1 ratio) to either (a) three sessions of brief behavioral parent training with optional booster sessions, or (b) CAU, as regularly provided by the involved mental healthcare centers. The study outcomes are measured at baseline before randomization (T0), one week after the third session for parents in the brief behavioral parent training arm and eight weeks after T0 for parents in the CAU arm (first posttreatment measurement, T1), six months after T1 (second posttreatment measurement, T2) and twelve months after T1 (third posttreatment measurement, T3). STUDY POPULATION: Parents of children who experience behavioral difficulties in the home setting and were referred to a child mental healthcare center. INTERVENTION: Parents in the intervention arm receive a short, individualized, three-session training primarily aimed at reducing children's behavioral problems. It exists of two (bi)weekly individually tailored training sessions of two hours and a third session of one hour in which the training will be evaluated, and maintenance training will be provided. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and/or receive care as usual. Parents in the control arm receive care as usual for children's behavioral problems. The treatments in both arms are fully embedded in Dutch routine mental health care. MAIN STUDY PARAMETERS: The primary outcome is the severity of four individual target behavioral difficulties that parents want to address in the training. Secondary outcomes are parent-reported behavioral difficulties, parent-reported child well-being, parent-reported parenting behaviors, masked audio records of mealtime routines to measure parent and child behavior, parent-reported parenting stress, parent-reported parenting self-efficacy, parent-reported parental attitude towards their child, consumption and cost of mental health care, and health state utility values. We furthermore measure evaluations of the program by parents and therapists and explore whether parental attachment, parental psychopathology, parental reward responsivity, parent-reported child reward responsivity and punishment sensitivity moderate the intervention effects.

Conditions

Disruptive Behavior; Behavior Problems; Behavioral Problems; Problem Behaviors; Behavioral Symptoms; Behavioral Difficulties

Keywords

Parent Training; Behavioral Parent Training; Brief Parent Training; Individually-Tailored Parent Training; Booster Sessions; Disruptive Behavior; Children; Randomized Controlled Trial; Clinical Trial; Brief Treatment

Outcome Measures

Primary Outcomes (1)

• Change in individually determined daily ratings of behavioral difficulties

  The primary outcome is the mean severity of parents' daily ratings of four selected target behaviors in specific home situations. On the adapted version of the list of target behaviors (Van den Hoofdakker et al., 2007; Hornstra et al., 2021), parents indicate whether the 29 behaviors occur daily (yes/no). For behaviors scored as yes, parents rate the severity on a 5-point Likert scale ranging from 1 (not severe) to 5 (extremely severe). With a researcher, parents choose four daily occurring target behaviors from this list that they prefer to work on in the training. Parents also indicate in which situation these behaviors occur. For each measurement occasion, during five consecutive weekdays, short daily phone calls with parents are made to evaluate whether the four selected target behaviors occurred in the past 24 hours in the selected situation (yes/no). For each timepoint, the average score of all four behaviors on all weekdays is used as outcome measure.

  Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)

Secondary Outcomes (14)

• Change in parent-reported behavioral difficulties

  A week before T0, one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), twelve months after T1 (T3), during and two weeks after each booster session for parents who receive the brief parent training.

• Change in child well-being

  Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)

• Change in parenting behaviors

  Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)

• Change in observed parent and child behaviors (audiotapes - masked measure)

  Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), and twelve months after T1 (T3)

• Change in parenting stress

  Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)

Study Arms (2)

Brief behavioral parent training with optional booster sessions

EXPERIMENTAL

A brief, individualized, three-session parent training that exists of two (bi)weekly individually tailored training sessions of two hours and a third session of one hour in which the training will be evaluated, and maintenance training will be provided. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and/or receive care as usual.

Behavioral: Brief behavioral parent training with optional booster sessions

Care as usual (CAU)

ACTIVE COMPARATOR

The care that is usually provided by the clinical institutions to treat children's disruptive behaviors. There will be no restrictions regarding type or duration of CAU (only the brief parent training will not be allowed) which may for example include psychoeducation, (long) parent training, child treatment (e.g., pharmacotherapy, cognitive behavioral therapy) or family therapy.

Behavioral: Care as usual

Interventions

Brief behavioral parent training with optional booster sessions BEHAVIORAL

A brief and individually-tailored behavioral parent training program that combines stimulus control and contingency management techniques to treat children's behavioral difficulties in three (bi)weekly sessions and optional booster sessions.

Also known as: PAINT-P (Parent), PAINT-GGZ, Brief parent training

Brief behavioral parent training with optional booster sessions

Care as usual BEHAVIORAL

The care that is usually provided by the clinical institutions to treat children's behavioral difficulties. There are no restrictions regarding type or duration of CAU (only the brief parent training will not be allowed) which may for example include psychoeducation, (long) parent training, child treatment (e.g., pharmacotherapy, cognitive behavioral therapy) or family therapy.

Also known as: CAU

Care as usual (CAU)

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child is aged between 2 and 12 years;
• Parents have to identify at least four behavioral difficulties of the child that occur in the home setting and that they want to target in the training, using an adapted version of a list of target behaviors (Van den Hoofdakker et al., 2007; Hornstra et al., 2021). This list contains 29 behaviors that can be targeted in the training, such as hyperactive, impulsive, inattentive, oppositional and defiant behavior. The items are derived from target problems that parents mentioned in previous behavioral parent training groups and concern child behaviors that are commonly targeted in behavioral parent training in clinical practice, confirming ecological validity (Van den Hoofdakker et al., 2007).

You may not qualify if:

• The child uses psychotropic medication (currently or in the month before the screening);
• The child has at any time received a diagnosis of autism spectrum disorder (ASD) in clinical practice, as (parents of) children with ASD may have different needs and therefore may require different treatments than children with behavioral difficulties without ASD;
• The child has a known IQ-score below 70, as (parents of) children with intellectual disabilities may have different needs and therefore may require different treatments than children with behavioral difficulties and typical intellectual abilities;
• Parents received behavioral parent training aimed at reducing the behavioral difficulties of the concerned child in the year prior to the start of the study;
• It is not a suitable period for the parents and/or the child to participate in the study (e.g., moving, divorce);
• The child is not living in the same household as the parent(s) who participate(s) in the trial during at least four weekdays (to ensure that our primary outcome can be reported by the same informant(s) and that parents can apply the intervention plans at home).

Sponsors & Collaborators

• Accare: lead

Study Sites (1)

Accare

Groningen, 9723 HE, Netherlands

RECRUITING

Related Publications (51)

• Abikoff HB, Thompson M, Laver-Bradbury C, Long N, Forehand RL, Miller Brotman L, Klein RG, Reiss P, Huo L, Sonuga-Barke E. Parent training for preschool ADHD: a randomized controlled trial of specialized and generic programs. J Child Psychol Psychiatry. 2015 Jun;56(6):618-31. doi: 10.1111/jcpp.12346. Epub 2014 Oct 16.

  PMID: 25318650 BACKGROUND

• Abikoff H, Gallagher R, Wells KC, Murray DW, Huang L, Lu F, Petkova E. Remediating organizational functioning in children with ADHD: immediate and long-term effects from a randomized controlled trial. J Consult Clin Psychol. 2013 Feb;81(1):113-28. doi: 10.1037/a0029648. Epub 2012 Aug 13.

  PMID: 22889336 BACKGROUND

• Allan, C., & Chacko, A. (2018). Adverse events in behavioral parent training for children with ADHD: An under-appreciated phenomenon. The ADHD Report, 26(1), 4-9. https://doi.org/10.1521/adhd.2018.26.1.4

  BACKGROUND

• Bakker MJ, Greven CU, Buitelaar JK, Glennon JC. Practitioner Review: Psychological treatments for children and adolescents with conduct disorder problems - a systematic review and meta-analysis. J Child Psychol Psychiatry. 2017 Jan;58(1):4-18. doi: 10.1111/jcpp.12590. Epub 2016 Aug 8.

  PMID: 27501434 BACKGROUND

• Bearss K, Johnson C, Handen B, Smith T, Scahill L. A pilot study of parent training in young children with autism spectrum disorders and disruptive behavior. J Autism Dev Disord. 2013 Apr;43(4):829-40. doi: 10.1007/s10803-012-1624-7.

  PMID: 22941342 BACKGROUND

• Berry, J. O., & Jones, W. H. (1995). The parental stress scale: Initial psychometric evidence. Journal of Social and Personal Relationships, 12, 463-472. http://dx.doi.org/10.1177/0265407595123009

  BACKGROUND

• Bouwmans, 2012, Handleiding vragenlijst intensieve jeugdzorg: zorggebruik en productieverlies.

  BACKGROUND

• Breider S, de Bildt A, Nauta MH, Hoekstra PJ, van den Hoofdakker BJ. Self-directed or therapist-led parent training for children with attention deficit hyperactivity disorder? A randomized controlled non-inferiority pilot trial. Internet Interv. 2019 Aug 8;18:100262. doi: 10.1016/j.invent.2019.100262. eCollection 2019 Dec.

  PMID: 31890615 BACKGROUND

• Chow, J. C., & Wehby, J. H. (2016). Associations Between Language and Problem Behavior: a Systematic Review and Correlational Meta-analysis. In Educational Psychology Review (Vol. 30, Issue 1, pp. 61-82). Springer Science and Business Media LLC. https://doi.org/10.1007/s10648-016-9385-z

  BACKGROUND

• Dekkers TJ, Hornstra R, van der Oord S, Luman M, Hoekstra PJ, Groenman AP, van den Hoofdakker BJ. Meta-analysis: Which Components of Parent Training Work for Children With Attention-Deficit/Hyperactivity Disorder? J Am Acad Child Adolesc Psychiatry. 2022 Apr;61(4):478-494. doi: 10.1016/j.jaac.2021.06.015. Epub 2021 Jul 2.

  PMID: 34224837 BACKGROUND

• Drost, R. M. W. A., Paulus, A. T. G., Ruwaard, D., & Evers, S. M. A. A. (2014). Handleiding intersectorale kosten en baten van (preventieve) interventies. Classificatie, identificatie en kostprijzen.

  BACKGROUND

• Drummond et al., (2015). Methods for the economic evaluation of health care programs (Fourth edition). Oxford University Press.

  BACKGROUND

• DuPaul, G. J., & Barkley, R. A. (1992). Situational Variability of Attention Problems: Psychometric Properties of the Revised Home and School Situations Questionnaires. In Journal of Clinical Child Psychology (Vol. 21, Issue 2, pp. 178-188). Informa UK Limited. https://doi.org/10.1207/s15374424jccp2102_10

  BACKGROUND

• Eyberg, S. (1993). Consumer satisfaction measures for assessing parent training programs. In L. VandeCreek, S. Knapp, & T. L. Jackson (Eds.), Innovations in clinical practice: A source book, Vol. 12, pp. 377-382). Professional Resource Press/Professional Resource Exchange.

  BACKGROUND

• Eyberg SM, Johnson SM. Multiple assessment of behavior modification with families: effects of contingency contracting and order of treated problems. J Consult Clin Psychol. 1974 Aug;42(4):594-606. doi: 10.1037/h0036723. No abstract available.

  PMID: 4847264 BACKGROUND

• Eyberg, S. M., & Pincus, D. (1999). ECBI & SESBI-R: Eyberg child behavior inventory and sutter-eyberg student behavior inventory-revised: Professional manual. Lutz, Florida: Psychological Assessment Resources.

  BACKGROUND

• Eyberg, S. M., & Robinson, E. A. (1983). Conduct problem behavior: Standardization of a behavioral rating. In Journal of Clinical Child Psychology (Vol. 12, Issue 3, pp. 347-354). Informa UK Limited. https://doi.org/10.1080/15374418309533155

  BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Franke B, Michelini G, Asherson P, Banaschewski T, Bilbow A, Buitelaar JK, Cormand B, Faraone SV, Ginsberg Y, Haavik J, Kuntsi J, Larsson H, Lesch KP, Ramos-Quiroga JA, Rethelyi JM, Ribases M, Reif A. Live fast, die young? A review on the developmental trajectories of ADHD across the lifespan. Eur Neuropsychopharmacol. 2018 Oct;28(10):1059-1088. doi: 10.1016/j.euroneuro.2018.08.001. Epub 2018 Sep 6.

  PMID: 30195575 BACKGROUND

• Furlong M, McGilloway S. The longer term experiences of parent training: a qualitative analysis. Child Care Health Dev. 2015 Sep;41(5):687-96. doi: 10.1111/cch.12195. Epub 2014 Sep 24.

  PMID: 25256901 BACKGROUND

• Gottschalk et al., (1969). The measurement of psychological states through the content analysis of verbal behavior. California Press.

  BACKGROUND

• Herbert SD, Harvey EA, Roberts JL, Wichowski K, Lugo-Candelas CI. A randomized controlled trial of a parent training and emotion socialization program for families of hyperactive preschool-aged children. Behav Ther. 2013 Jun;44(2):302-16. doi: 10.1016/j.beth.2012.10.004. Epub 2012 Nov 10.

  PMID: 23611079 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Hornstra R, van der Oord S, Staff AI, Hoekstra PJ, Oosterlaan J, van der Veen-Mulders L, Luman M, van den Hoofdakker BJ. Which Techniques Work in Behavioral Parent Training for Children with ADHD? A Randomized Controlled Microtrial. J Clin Child Adolesc Psychol. 2021 Nov-Dec;50(6):888-903. doi: 10.1080/15374416.2021.1955368. Epub 2021 Aug 23.

  PMID: 34424102 BACKGROUND

• Johnston, C., & Mash, E. J. (1989). A Measure of Parenting Satisfaction and Efficacy. In Journal of Clinical Child Psychology (Vol. 18, Issue 2, pp. 167-175). Informa UK Limited. https://doi.org/10.1207/s15374424jccp1802_8

  BACKGROUND

• Kaminski JW, Claussen AH. Evidence Base Update for Psychosocial Treatments for Disruptive Behaviors in Children. J Clin Child Adolesc Psychol. 2017 Jul-Aug;46(4):477-499. doi: 10.1080/15374416.2017.1310044. Epub 2017 May 1.

  PMID: 28459280 BACKGROUND

• Kaminski JW, Valle LA, Filene JH, Boyle CL. A meta-analytic review of components associated with parent training program effectiveness. J Abnorm Child Psychol. 2008 May;36(4):567-89. doi: 10.1007/s10802-007-9201-9. Epub 2008 Jan 19.

  PMID: 18205039 BACKGROUND

• Kolko DJ, Lindhiem O. Introduction to the special series on booster sessions and long-term maintenance of treatment gains. J Abnorm Child Psychol. 2014;42(3):339-42. doi: 10.1007/s10802-013-9849-2. No abstract available.

  PMID: 24414018 BACKGROUND

• Lange A, Evers A, Jansen H, Dolan C. PACHIQ-R: the Parent-Child Interaction Questionnaire--revised. Fam Process. 2002 Winter;41(4):709-22. doi: 10.1111/j.1545-5300.2002.00709.x.

  PMID: 12613126 BACKGROUND

• Leijten P, Gardner F, Melendez-Torres GJ, van Aar J, Hutchings J, Schulz S, Knerr W, Overbeek G. Meta-Analyses: Key Parenting Program Components for Disruptive Child Behavior. J Am Acad Child Adolesc Psychiatry. 2019 Feb;58(2):180-190. doi: 10.1016/j.jaac.2018.07.900. Epub 2018 Nov 26.

  PMID: 30738545 BACKGROUND

• Leijten P, Melendez-Torres GJ, Gardner F. Research Review: The most effective parenting program content for disruptive child behavior - a network meta-analysis. J Child Psychol Psychiatry. 2022 Feb;63(2):132-142. doi: 10.1111/jcpp.13483. Epub 2021 Jul 9.

  PMID: 34240409 BACKGROUND

• Linden M. How to define, find and classify side effects in psychotherapy: from unwanted events to adverse treatment reactions. Clin Psychol Psychother. 2013 Jul-Aug;20(4):286-96. doi: 10.1002/cpp.1765. Epub 2012 Jan 18.

  PMID: 22253218 BACKGROUND

• Lipszyc J, Schachar R. Inhibitory control and psychopathology: a meta-analysis of studies using the stop signal task. J Int Neuropsychol Soc. 2010 Nov;16(6):1064-76. doi: 10.1017/S1355617710000895. Epub 2010 Aug 19.

  PMID: 20719043 BACKGROUND

• Luman M, van Meel CS, Oosterlaan J, Geurts HM. Reward and punishment sensitivity in children with ADHD: validating the Sensitivity to Punishment and Sensitivity to Reward Questionnaire for children (SPSRQ-C). J Abnorm Child Psychol. 2012 Jan;40(1):145-57. doi: 10.1007/s10802-011-9547-x.

  PMID: 21789519 BACKGROUND

• Marsh AA, Blair RJ. Deficits in facial affect recognition among antisocial populations: a meta-analysis. Neurosci Biobehav Rev. 2008;32(3):454-65. doi: 10.1016/j.neubiorev.2007.08.003. Epub 2007 Sep 1.

  PMID: 17915324 BACKGROUND

• Matthys W, Vanderschuren LJ, Schutter DJ. The neurobiology of oppositional defiant disorder and conduct disorder: altered functioning in three mental domains. Dev Psychopathol. 2013 Feb;25(1):193-207. doi: 10.1017/S0954579412000272. Epub 2012 Jul 17.

  PMID: 22800761 BACKGROUND

• McCart MR, Priester PE, Davies WH, Azen R. Differential effectiveness of behavioral parent-training and cognitive-behavioral therapy for antisocial youth: a meta-analysis. J Abnorm Child Psychol. 2006 Aug;34(4):527-43. doi: 10.1007/s10802-006-9031-1. Epub 2006 Jul 13.

  PMID: 16838122 BACKGROUND

• McMahon, R. J., & Forehand, R. L. (2019). Helping the Noncompliant Child. In Encyclopedia of Couple and Family Therapy (pp. 1359-1364). Springer International Publishing. https://doi.org/10.1007/978-3-319-49425-8_382

  BACKGROUND

• Noordermeer SDS, Luman M, Buitelaar JK, Hartman CA, Hoekstra PJ, Franke B, Faraone SV, Heslenfeld DJ, Oosterlaan J. Neurocognitive Deficits in Attention-Deficit/Hyperactivity Disorder With and Without Comorbid Oppositional Defiant Disorder. J Atten Disord. 2020 Jul;24(9):1317-1329. doi: 10.1177/1087054715606216. Epub 2015 Oct 20.

  PMID: 26486602 BACKGROUND

• Ravens-Sieberer U, Bullinger M. Assessing health-related quality of life in chronically ill children with the German KINDL: first psychometric and content analytical results. Qual Life Res. 1998 Jul;7(5):399-407. doi: 10.1023/a:1008853819715.

  PMID: 9691720 BACKGROUND

• Reef J, Diamantopoulou S, van Meurs I, Verhulst FC, van der Ende J. Developmental trajectories of child to adolescent externalizing behavior and adult DSM-IV disorder: results of a 24-year longitudinal study. Soc Psychiatry Psychiatr Epidemiol. 2011 Dec;46(12):1233-41. doi: 10.1007/s00127-010-0297-9. Epub 2010 Oct 10.

  PMID: 20936464 BACKGROUND

• Schoemaker K, Mulder H, Dekovic M, Matthys W. Executive functions in preschool children with externalizing behavior problems: a meta-analysis. J Abnorm Child Psychol. 2013 Apr;41(3):457-71. doi: 10.1007/s10802-012-9684-x.

  PMID: 23054130 BACKGROUND

• Shelton, K. K., Frick, P. J., & Wootton, J. (1996). Assessment of Parenting Practices in Families of Elementary School-Age Children. Journal of Clinical Child Psychology, 25, 317-329. https://doi.org/10.1207/s15374424jccp2503_8

  BACKGROUND

• Tully, L. A., & Hunt, C. (2015). Brief Parenting Interventions for Children at Risk of Externalizing Behavior Problems: A Systematic Review. In Journal of Child and Family Studies (Vol. 25, Issue 3, pp. 705-719). Springer Science and Business Media LLC. https://doi.org/10.1007/s10826-015-0284-6

  BACKGROUND

• Twisk J, de Boer M, de Vente W, Heymans M. Multiple imputation of missing values was not necessary before performing a longitudinal mixed-model analysis. J Clin Epidemiol. 2013 Sep;66(9):1022-8. doi: 10.1016/j.jclinepi.2013.03.017. Epub 2013 Jun 21.

  PMID: 23790725 BACKGROUND

• Van den Berg I, Franken IH, Muris P. A new scale for measuring reward responsiveness. Front Psychol. 2010 Dec 31;1:239. doi: 10.3389/fpsyg.2010.00239. eCollection 2010.

  PMID: 21922010 BACKGROUND

• van den Hoofdakker BJ, van der Veen-Mulders L, Sytema S, Emmelkamp PMG, Minderaa RB, Nauta MH. Effectiveness of behavioral parent training for children with ADHD in routine clinical practice: a randomized controlled study. J Am Acad Child Adolesc Psychiatry. 2007 Oct;46(10):1263-1271. doi: 10.1097/chi.0b013e3181354bc2.

  PMID: 17885567 BACKGROUND

• Weeland J, van Aar J, Overbeek G. Dutch Norms for the Eyberg Child Behavior Inventory: Comparisons with other Western Countries. J Psychopathol Behav Assess. 2018;40(2):224-234. doi: 10.1007/s10862-017-9639-1. Epub 2017 Dec 2.

  PMID: 29937620 BACKGROUND

• Wei M, Russell DW, Mallinckrodt B, Vogel DL. The Experiences in Close Relationship Scale (ECR)-short form: reliability, validity, and factor structure. J Pers Assess. 2007 Apr;88(2):187-204. doi: 10.1080/00223890701268041.

  PMID: 17437384 BACKGROUND

• Weisenmuller C, Hilton D. Barriers to access, implementation, and utilization of parenting interventions: Considerations for research and clinical applications. Am Psychol. 2021 Jan;76(1):104-115. doi: 10.1037/amp0000613. Epub 2020 Mar 5.

  PMID: 32134281 BACKGROUND

• van Doornik RS, van der Oord S, Luijckx J, Groenman AP, Leijten P, Luman M, Hoekstra PJ, van den Hoofdakker BJ, Dekkers TJ. The short- and longer-term effects of brief behavioral parent training versus care as usual in children with behavioral difficulties: study protocol for a randomized controlled trial. BMC Psychiatry. 2024 Mar 12;24(1):203. doi: 10.1186/s12888-024-05649-8.

  PMID: 38475768 DERIVED

MeSH Terms

Conditions

Problem Behavior; Mental Disorders; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior; Child Behavior

Study Officials

• Barbara J. Van den Hoofdakker, Prof. dr.

  Accare Child Study Center; University Medical Center Groningen; University of Groningen

  PRINCIPAL INVESTIGATOR

• Saskia Van der Oord, Prof. dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roos S. van Doornik, MSc.

CONTACT

0031659820639; r.van.doornik@accare.nl

Tycho J. Dekkers, dr.

CONTACT

t.dekkers@accare.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors who will code the records of mealtime routines made by parents will be unaware of in which arm parents in the study are participating. The audio records will therefore be a masked measure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To examine the research objectives, a randomized controlled trial with two arms is used. Referred children and their parents will be randomly assigned (equal randomization) to (a) brief parent training, with optional booster sessions up to one year after the training, or (b) care as usual (CAU), as regularly provided by the mental health centers involved. Children in the brief parent training group will not receive CAU until the first posttreatment assessment (T1). After that, CAU is allowed and parents can make use of booster sessions (maximum once every four weeks) with the therapist who provided the training.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 24, 2022
• Study Start: October 17, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)