Psychosocial ADHD Interventions - Brief Parent Training

NCT05452954 | Completed

• 1 other identifier: METc 2020/459
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study investigates a new, easily applicable, individually tailored first-line behavioral training for parents of children (4-12 years) with (symptoms of) ADHD, that will be provided in an early stage, before other treatments have been applied. In this pilot study the feasibility of the newly developed intervention will be evaluated by exploring program acceptability, including client satisfaction, recruitment, retention, treatment fidelity and therapist satisfaction. Also acceptability of potential outcome measures will be explored, including preliminary tests of efficacy.

Conditions

ADHD; ADHD - Combined Type; ADHD Predominantly Inattentive Type; ADHD, Predominantly Hyperactive-Impulsive Type; Behavior Problem; Behavioral Problem; Problem Behavior; Behavioral Symptoms; Child Behavior Problem; Disruptive Behavior

Keywords

behavioral parent training; brief behavioral parent training; first-line behavioral parent training; psychosocial ADHD intervention; parent training; first-line treatment ADHD; children 4-11 years

Outcome Measures

Primary Outcomes (1)

• Change in daily ratings of target behaviors by ecological momentary assessment

  The primary outcome measure will be daily ratings of 4 selected target behaviors. The target behaviors will be selected from a list of 31 problem behaviors on which parents indicate whether these behaviors daily occur (yes/no). For the items scored as yes parents rate the severity of the behaviors on a 5-point Likertscale ranging from 1 not severe to 5 extremely severe. Parents will be asked to choose 4 target behaviors from this list (i.e. the behaviors that they prefer to work on in the training). They will also be asked to specify in which situations these behaviors typically occur. During a week (5 schooldays), a member of the research team will make daily phone calls with participating parents to evaluate whether the 4 selected target behaviors occurred in the past 24 hours (yes/no). Items scored as No will be rated 0, items scored as Yes will be rated on a 5-point Likertscale ranging from 1 not severe to 5 extremely severe (daily score min = 0, max = 20).

  T0 (baseline) 1 week before intervention; T1 (post-training 1) 1 week after intervention session 2; T2 (post-training 2) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session.

Secondary Outcomes (5)

• Change in inattentive, hyperactive and impulsive behaviors of the child.

  T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session

• Change in children's symptoms of oppositional defiant disorder

  T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session

• Change in disruptive problem behaviors of the child

  T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session

• Change in impairment of the child

  T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session

• Change in parenting sense of competence

  T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session

Other Outcomes (6)

• Parent satisfaction

  T3 (follow-up) 3 weeks after intervention booster session

• Parent-rated acceptability of outcome measures

  T3 (follow-up) 3 weeks after intervention booster session

• Therapist satisfaction

  Through study completion, an average of 1,5 year.

Study Arms (1)

Brief behavioral parent training

OTHER

A newly developed, easily applicable, individually tailored first-line behavioral training for parents of children (4-12 years) with behavioral problems and (symptoms of) ADHD, that will be provided in an early stage, before other treatments have been applied.

Behavioral: Brief behavioral parent training

Interventions

Brief behavioral parent training BEHAVIORAL

In the newly developed intervention, both stimulus control and contingency management techniques will be offered in a brief behavioral parent training consisting of two intervention sessions and one booster session.

Also known as: paint-p, Psychosocial ADHD Interventions - Parent-training

Brief behavioral parent training

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A) The child is diagnosed with ADHD according to DSM-5 as measured by the Parent Interview for Child Symptoms \[PICS\] and the Teacher Telephone Interview \[TTI\] or; B) The child has at least four impairing symptoms of ADHD (at least four symptoms of ADHD as measured by the Parent Interview for Child Symptoms \[PICS\] and at least two symptoms measured by the Teacher Telephone Interview \[TTI\]; and significant impairment rated \>3 on the Impairment Rating Scale \[IRS\]).
• The child is between four up to and including eleven years old and is attending a Dutch primary school.
• The child has an IQ higher than 70. If an IQ-score is not available, this will be estimated with two subtests of the Wechsler Intelligence Scale for Children-V (Dutch edition; WISC-V-NL) or the Wechsler Preschool and Primary Scale of Intelligence-III (Dutch edition; WPSSI-III-NL).
• Parents/caregivers have given their informed consent for participation.

You may not qualify if:

• Parents received behavioral parent training (individual or group) aimed at ADHD or behavioral problems of the child in the past year.
• The child is currently taking psychotropic medication or has taken psychotropic medication in the past month.
• The child has a DSM-5 or a DSM-IV-TR based diagnosis of an Autism Spectrum Disorder.
• There are problems with the child and/or the family that require immediate intensive intervention (e.g., crisis in the family).
• The child does not live in one household during weekdays.

Sponsors & Collaborators

• Accare: lead

Study Sites (1)

Accare

Groningen, 9723 HE, Netherlands

Location

Related Publications (22)

• 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.

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• Oosterlaan, J., Baeyens, D., Scheres, A., Antrop, I., Roeyers, H., & Sergeant, J. (2008). VvGK6-16: Vragenlijst voor gedragsproblemen bij kinderen 6 tot en met 16 jaar. Amsterdam: Pearson.

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• 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

• van der Veen-Mulders L, Hoekstra PJ, Nauta MH, van den Hoofdakker BJ. Preschool children's response to behavioural parent training and parental predictors of outcome in routine clinical care. Clin Psychol Psychother. 2018 Jan;25(1):1-9. doi: 10.1002/cpp.2117. Epub 2017 Aug 30.

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  PMID: 16836475 BACKGROUND

• Gibaud-Wallston, J., & Wandersman, L. P. (1978). Development and utility of the parenting sense of competence scale. Paper presented at the Annual Meeting of the American Psychological Association, Toronto.

  BACKGROUND

• Johnston, C., & Mash, E. J. (1989). A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology, 18(2), 167-175. doi:10.1207/s15374424jccp1802_8

  BACKGROUND

• van der Veen-Mulders L, Hoekstra PJ, Nauta MH, van den Hoofdakker BJ. Are parental changes related to improvements in preschool children's disruptive behaviours? Clin Psychol Psychother. 2020 Jan;27(1):24-33. doi: 10.1002/cpp.2402. Epub 2019 Dec 4.

  PMID: 31614051 BACKGROUND

• Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.

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• Ohan, J. L., Leung, D. W., & Johnston, C. (2000). The parenting sense of competence scale: Evidence of a stable factor structure and validity. Canadian Journal of Behavioural Science / Revue Canadienne Des Sciences Du Comportement, 32(4), 251-261. doi:10.1037/h0087122

  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.

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• Eyberg, S. M. (1993). Consumer satisfaction measures for assessing parent training programs. In L. VandeCreek, S. Knapp & T. L. Jackson (Eds.), (pp. 377-382). Sarasota, FL: Professional Resource Press/Professional Resource Exchange. Retrieved from http://search.ebscohost.com.proxy-ub.rug.nl/login.aspx?direct=true&db=psyh&AN=1994-97027-025&site=ehost-live&scope=site

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• 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

• APA. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Association.

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• 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

• 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

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Mental Disorders; Problem Behavior; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Behavior; Child Behavior

Study Officials

• B. J. Van den Hoofdakker, Prof. dr.

  Accare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: July 12, 2022
• Study Start: March 16, 2021
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)