Behavioral Symptoms Clinical Trial
— PAINT-GGZOfficial title:
A Randomized Controlled Trial on Brief Behavioral Parent Training Versus Care as Usual in Children With Behavioral Difficulties
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.
Status | Recruiting |
Enrollment | 93 |
Est. completion date | December 2026 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 11 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Netherlands | Accare | Groningen |
Lead Sponsor | Collaborator |
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Accare |
Netherlands,
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. — View Citation
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. — View Citation
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
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. — View Citation
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. — View Citation
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
Bouwmans, 2012, Handleiding vragenlijst intensieve jeugdzorg: zorggebruik en productieverlies.
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. — View Citation
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
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. — View Citation
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.
Drummond et al., (2015). Methods for the economic evaluation of health care programs (Fourth edition). Oxford University Press.
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
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. — View Citation
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.
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.
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
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. — View Citation
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. — View Citation
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. — View Citation
Gottschalk et al., (1969). The measurement of psychological states through the content analysis of verbal behavior. California Press.
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. — View Citation
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. — View Citation
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. — View Citation
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
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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
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
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in parent-reported behavioral difficulties | Change in parent-reported child disruptive behaviors is assessed with the Intensity scale of the Eyberg Child Behavior Inventory (ECBI-I) (Eyberg & Ross, 1978). The Intensity scale consists of 36-items for parents of children aged 2 to 16 and measures the frequency of specific problem behavior on a 7-point Likert scale from 1 (never) to 7 (always). The convergent and divergent validity and the reliability of the ECBI-I are well established (Abrahamse et al., 2015). | 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. | |
Secondary | Change in child well-being | Change in child well-being is assessed with the Health-Related Quality of Life Questionnaire (KINDL-R) (Ravens-Sieberer & Bullinger, 1998). Parents rate their children's quality of life on 20 items regarding emotional well-being, self-esteem, family functioning, social contacts, and school, of which the total score will be used. Parents rate the items on a Likert scale ranging from 1 (never) to 5 (all the time). The KINDL-R has revealed sufficient internal consistency (a = .82) (Bullinger et al., 2008). | 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 | Change in parenting behaviors | Change in parenting behaviors is assessed with the Alabama Parenting Questionnaire (APQ; Shelton et al., 1996). The APQ is a 42-item parent-report measure assessing five categories of parenting practices (involvement, positive parenting, poor monitoring/supervision, inconsistent discipline, and corporal punishment), of which the total score will be used. Parents rate their parenting on a 5-point scale ranging from 1 (never) to 5 (always), with higher scores representing higher levels of the particular parenting category. The reliability and validity of the APQ are well established (Shelton et al., 1996). | 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 | Change in observed parent and child behaviors (audiotapes - masked measure) | Change in observed parent and child behaviors is assessed with a masked measure. Parents are asked to audio record their mealtime routines for at least 15 minutes on two different weekdays. Mealtimes are notoriously busy times in family lives and thus well suited as a setting for an ecologically valid measure. The recordings of mealtime routines are a masked measure (i.e., assessors are not aware of the intervention condition), based on the method that was used by Herbert et al. (2013). Using the recordings, the following behaviors will be scored with a global coding system: parental behavior (both supportive and non-supportive parenting), child misbehavior, and emotional talk. A subsample of recordings will be double coded until sufficient interrater reliability is established. | 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) | |
Secondary | Change in parenting stress | Change in parenting stress is assessed with the Parental Stress Scale (PSS; Berry & Jones, 1995). The PSS is an 18-item parent report scale that measures positive (e.g., emotional benefits) and negative (e.g., restrictions) aspects of parenting, of which the total score will be used. Parents have to agree or disagree with statements concerning parenting on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). The adequate reliability (a = .83) and validity of the PSS have been demonstrated (Berry & Jones, 1995). | 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 | Change in parenting self-efficacy | Change in parenting self-efficacy is measured with the subscale Efficacy of the Parenting Sense of Competence Scale (PSOC; Johnston & Mash, 1989). On the eight items of this subscale, parents rate their capability level and problem-solving ability regarding their parental role on a 6-point scale, ranging from 1 (strongly disagree) to 6 (strongly agree). The internal consistency (a = .76) of the subscale Efficacy has been established (Johnston & Mash, 1989). | 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 | Change in quality of the parent-child relation | Change in quality of the parent-child relation is measured with the parent version of the Parent-Child Interaction Questionnaire-Revised (PACHIQ-R; Lange et al., 2002). On 21 items, parents rate their relationship with their child on a 5-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree), of which the total score will be used. The PACHIQ-R has been demonstrated to have high internal consistency (ranging between a = .79 and a = .93) (Lange et al., 2002). | 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 | Evaluations of the program by parents - Questionnaire | To measure parents' satisfaction and opinion about the brief parent training, parents are asked to fill out a self-developed satisfaction questionnaire, which is based on questions of the Parent Satisfaction Questionnaire (Bearss et al., 2013), the Therapy Attitude Inventory (Eyberg, 1993; Eyberg & Johnson, 1974), and the satisfaction questionnaire that was used in Breider et al. (2019). Parents who received the brief behavioral parent training answer 13 questions about their satisfaction with the brief behavioral parent training at T1 and three questions about their satisfaction with the booster sessions (if used) at T3 on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). Parents also grade the brief behavioral parent training generally between 1 (very bad) and 10 (excellent). | One week after the brief training/eight weeks after T0 (T1) and twelve months after T1 (T3) for parents who receive the brief parent training. | |
Secondary | Evaluations of the program by parents - Focus Groups | To measure parents' satisfaction and opinion about the brief parent training, one or multiple focus group(s) will be organized with a small number of parents. In this focus group the new program will be qualitatively evaluated and information about feasibility and barriers and facilitators for the implementation of the training in clinical settings will be gathered. | After the inclusion of participants in the trial is finished, which is anticipated to be at the beginning of 2025. | |
Secondary | Evaluations of the program by therapists - Questionnaire | To measure therapists' satisfaction and opinion about the brief parent training, therapists will be asked to fill in a self-developed satisfaction questionnaire, which is based on questions of the Parent Satisfaction Questionnaire (Bearss et al., 2013), the Therapy Attitude Inventory (Eyberg, 1993; Eyberg & Johnson, 1974), and the satisfaction questionnaire that was used in Breider et al. (2019). Therapists have to answer seven questions on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) and give the brief behavioral parent training a general grade between 1 (very bad) and 10 (excellent). | After the trial is finished, which is anticipated to be at the beginning of 2026. | |
Secondary | Evaluations of the program by therapists - Focus Groups | To measure therapists' satisfaction and opinion about the brief parent training, one or multiple focus group(s) will be organized with a selection of therapists from different healthcare centers who provided the brief parent training and range in years of work experience and to how many families they have provided the brief behavioral parent training. In the focus group(s), important barriers and facilitators for the implementation of the program will be identified. | After the trial is finished, which is anticipated to be at the beginning of 2026. | |
Secondary | Change in use of health care | Change in use of mental healthcare within the organization where the child is treated is measured by drawing up an inventory (based on patient records) of the type of care (brief behavioral parent training, booster sessions, CAU) that is used and the duration (in minutes) of this care between T0 and T3 in both arms. The broader use of healthcare within and outside the mental healthcare centers is assessed with the Vragenlijst Intensieve Jeugdzorg, a Dutch questionnaire on intensive youth care (Bouwmans et al., 2012). This questionnaire assesses the use of a wide variety of healthcare, along with the child's use of education, contact with judicial authorities, and losses in the productivity of parents. Parents complete this questionnaire about the use and intensity of healthcare of both the child and themselves in the past three months. Both measures of healthcare use (i.e., inventory of care and questionnaire) will be combined to obtain a complete image of all used care. | Before the brief training/before any intervention (T0) and twelve months after T1 (T3). | |
Secondary | Change in costs of health care | Change in healthcare costs is estimated from a societal perspective (Drummond et al., 2015). Costs of mental healthcare are estimated by multiplying the used care by the reference prices provided in the Cost Manual of the Dutch National Health Care Institute. Costs of medication are estimated by using prices provided by the Dutch National Health Care Institute (Zorginstituut Nederland, 2020). Costs in other sectors (e.g., education, justice) are estimated by using reference prices provided in the Manual Intersectoral Costs and Benefits (Drost et al., 2014). | All costs are estimated after families' participation in the study, when their healthcare use is fully measured. | |
Secondary | Change in utilities | Change in utilities, also called preferred health states, is assessed using quality-adjusted life years (QALYs). QALYs range between 0 and 1, where 0 represents death and 1 perfect health. QALYs are calculated based on the EuroQol-5D-5L (EQ-5D) questionnaire (EuroQol Research Foundation, 2019; Herdman et al., 2011), which parents fill out about their child. The EuroQol-5D-5L measures the child's health with five items (mobility, self-care, daily activities, pain, and anxiety/depression) on 5-level categorical scales. EQ-5D responses will be transferred into QALYs based on the Dutch EQ-5D-5L tariff for adults (Versteegh et al., 2016), as a tariff for Dutch children is not yet available. The content and face validity of the EuroQol-5D-5L are well established (Herdman et al., 2011). | Before the brief training/before any intervention (T0) and twelve months after T1 (T3). |
Status | Clinical Trial | Phase | |
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Completed |
NCT01217541 -
Collaboration Between Department of Old Age Psychiatry and Nursing Homes
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N/A | |
Completed |
NCT00365859 -
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