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ADHDPAINTNCT05452954

Psychosocial ADHD Interventions - Brief Parent Training

A study testing Brief behavioral parent training in people with ADHD and ADHD - Combined Type, run by Accare at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 11 years
What is being tested?
Brief behavioral parent training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteNetherlands
Study dates
16 Mar 2021to 6 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Accare

    Groningen, 9723 HE

Other trials in Netherlands

About this study

Official title: A Non-randomized Pilot Study on Brief Behavioral Parent Training for Behavioral Problems of Children With ADHD Symptoms.

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.

Read the detailed description

The study will be a non-randomized pilot study. The newly developed brief behavioral parent training has not been studied yet. Therefore, the current project aims at evaluating its feasibility. Furthermore, this project aims to explore whether parents' and their children's functioning improves from pre to post intervention. This will be assessed by investigating changes over time in the treatment group, and, if possible, by comparing these with changes in a control group that was included in a previous microtrial with an almost identical design and intervention.

OBJECTIVES

The primary objective of this study is evaluating the feasibility of the newly developed behavioral parent training This will be done by exploring its acceptability, including client satisfaction, recruitment, retention, treatment fidelity and therapist satisfaction. Furthermore, the acceptability of both primary and secondary outcome measures will be evaluated on a number of variables, such as frequency and duration of the assessment according to participants and response and completion rates. Preliminary tests of efficacy will be conducted by investigating changes over time in the treatment group, and, if possible, comparing all outcome measures with control data from a previous study that has an almost identical design.

METHODS

Design

Baseline measurement (all outcome measures) will be done one week before session 1 (T0). The primary outcome will be assessed one and three weeks after session 2 (T1 and T2). At T2, all other outcome measures will be assessed as well. Follow-up measurement (all outcome measures) will be done three weeks after the booster session (T3). Sessions and measurements are planned the same way as could be done in a future RCT.

Participants

Participants are parents of children between four up to and including eleven years old with behavioral problems and diagnosed with ADHD or at least four symptoms of ADHD according to DSM-5.

Treatment

The intervention consists of three sessions; two two-hours training sessions and a one-hour booster session. Treatment will take place in an outpatient child and adolescent mental health setting. Therapists will be well-trained in behavioral techniques and experienced in behavioral parent training for children with behavioral problems.

Outcome variables

To assess feasibility, the following outcome measures are investigated:

  • Parent satisfaction (25 items)
  • Parent-rated acceptability of primary and secondary outcome measures (7 descriptive items)
  • Therapist satisfaction (short self-developed evaluation questionnaire)
  • Treatment fidelity (audio records of sessions; percentage addressed session items)
  • Recruitment (average number of included patients each month, number of patients meeting the inclusion criteria but not willing to participate)
  • Retention rate (percentage study drop-out and percentage treatment drop-out)
  • Response and completion rates on outcome measures (percentage of parents that responded at all timepoints, percentage of completed measures at all time-points)

For a preliminary test of efficacy, primary outcomes are daily ratings of four individually selected target behaviors. Secondary outcomes are:

  • Inattentive, hyperactive and impulsive behaviors of the child (SWAN)
  • Children's symptoms of oppositional defiant disorder (DBDRS)
  • Disruptive problem behaviors of the child (ECBI)
  • Impairment of the child (IRS)
  • Parenting sense of competence (PSOC) See 'Outcomes Measures' for more details on all measures.

Statistics

For a preliminary test of efficacy, two research questions are formulated. The primary research question concerns the change from pre to post intervention within the treatment group. To analyze whether participants improve on daily ratings of problem behavior (primary outcome measure), a weekly mean-level will be derived on the basis of the daily ratings of the selected target behaviors in specific situations over five schooldays.

The secondary research question for preliminary efficacy concerns the comparison of the treatment group with historic controls. The change on primary and secondary outcome measures in the intervention group will be compared to the change in the historic control group.

Both research questions will be answered by a multilevel analysis (mixed modeling), which takes missing data into account. Three hierarchical levels will be distinguished: outcomes (level 1) nested within subjects (level 2), nested in therapists (level 3). A random intercept at therapist level will be included only if the Likelihood Ratio Test shows a significant improvement of the model fit. Condition (parent training vs control) will be inserted as between subjects factor and time (T1, T2, T3) as within subjects variable. To control for baseline differences, T0 scores will be inserted as fixed factor. As an historic control group will be used, also age, sex, ADHD symptoms (as measured by the SWAN) and ODD symptoms (as measured by the DBDRS) at T0 will be included, but only when groups differ on these variables at T0.

Data will be analyzed on an intention to treat basis. In all statistical analyses an alpha of 0.05 will be used.

Power analysis

A power analysis was executed for the primary pre-post within group analysis. Taking into account the lowest within condition effect size found in a previous study on brief behavioral parent training (d=.57), an effect size of f=.285 (f=d/2) is assumed for this power analysis. Given alpha=.05 and power 1-β=.80, a total number of 28 study participants will be required.

Being tested
Brief behavioral parent training
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
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Mental Disorders, Problem Behavior, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief behavioral parent trainingBehavioural

    Also called paint-p, Psychosocial ADHD Interventions - Parent-training

    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.

Study groups in NCT05452954
Study groupRoleWhat they receive
Brief behavioral parent trainingOtherA 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.
Receives: Behavioral: Brief behavioral parent training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

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

    Symptoms of inattentiveness, hyperactivity and impulsivity will be assessed by the Strengths and Weaknesses of ADHD symptoms and Normal behavior rating scale (SWAN). The SWAN is a list containing 18 items measuring inattentive, hyperactive, and impulsive behaviors. The SWAN is based on an earlier scale, the Swanson, Nolan and Pelham Teacher and Parent (SNAP) Rating Scale. It consists of 18 items, rated on a 7-point scale ranging from -3 'far below average' to 3 'far above average' (min = -54, max = 54). Reliability and validity have both been evaluated as adequate.

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

  2. Change in children's symptoms of oppositional defiant disorder

    A subscale (8 items) of the Dutch version of the Disruptive Behavior Disorder Rating Scales (DBDRS) will be used to identify symptoms of oppositional defiant disorder (ODD). The DBDRS has been designed to assess symptoms of externalizing disorders that can be completed by parents or teachers. The parent/caregiver is asked to indicate the degree to which a statement describes their child's behavior. Responses include; 'not at all' (0), 'just a little' (1), 'pretty much' (2), and 'very much' (3) (min = 0, max = 24). The subscale ODD has good construct validity and internal consistency (α = .88).

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

  3. Change in disruptive problem behaviors of the child

    Children's current disruptive problem behaviors will be assessed by the Dutch version of the Eyberg Child Behavior Inventory (ECBI). The ECBI is a 36-item questionnaire for parents of children aged 2 to 16, consisting of two scales. The intensity scale measures the frequency of specific problem behavior on a 7-point Likert scale (1=never to 7=always, min = 36, max = 252). On the problem scale, parents report whether the specific behavior-item is problematic for parents or not on a dichotomous scale (0=no, 1=yes; min = 0, max = 36). Psychometric qualities (internal consistency, test-retest reliability and validity) of the Dutch version of the ECBI are good.

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

  4. Change in impairment of the child

    Impairment of the child will be assessed with the Impairment Rating Scale (IRS). The IRS measures impairment on seven domains, including relationships with peers, siblings, and parents, family functioning, academic progress, self-esteem, and overall impairment. Caregivers are asked to score how impaired they think their child is in each domain, from 0 'no problem' to 6 'extreme problem' (min = 0, max = 42). The IRS has been demonstrated to validly identify impairment in children with ADHD, with a score of 3 or more indicating clinically significant impairment.

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

  5. Change in parenting sense of competence

    The subscale Efficacy of the Parenting Sense of Competence Scale (PSOC) will be used to measure parenting self-efficacy. It contains 8 items (e.g., 'Being a parent is manageable, and any problems are easily solved') on which parents have to indicate their level of agreement. Ratings have to be made on a 6-point scale, ranging from 1 'strongly agree' to 6 'strongly disagree' (min = 8, max = 42). Good internal consistency and construct validity have been reported.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study start16 Mar 2021
  3. Primary completion6 Apr 2023
  4. Study completion6 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open label
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452954
Sponsor's protocol ID
METc 2020/459
Acronym
PAINT
Status last verified
Jan 2024
First submitted
1 Jun 2022
Last updated
10 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17885567

  • Swanson JM, Schuck S, Porter MM, Carlson C, Hartman CA, Sergeant JA, Clevenger W, Wasdell M, McCleary R, Lakes K, Wigal T. Categorical and Dimensional Definitions and Evaluations of Symptoms of ADHD: History of the SNAP and the SWAN Rating Scales. Int J Educ Psychol Assess. 2012 Apr;10(1):51-70.

    PubMed 26504617

  • Swanson, J. M. (1992). School-based assessments and interventions for ADD students. Irvine, CA: KC Publishing.

  • Lakes KD, Swanson JM, Riggs M. The reliability and validity of the English and Spanish Strengths and Weaknesses of ADHD and Normal behavior rating scales in a preschool sample: continuum measures of hyperactivity and inattention. J Atten Disord. 2012 Aug;16(6):510-6. doi: 10.1177/1087054711413550. Epub 2011 Aug 1.

    PubMed 21807955

  • 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.

  • Pelham WE Jr, Gnagy EM, Greenslade KE, Milich R. Teacher ratings of DSM-III-R symptoms for the disruptive behavior disorders. J Am Acad Child Adolesc Psychiatry. 1992 Mar;31(2):210-8. doi: 10.1097/00004583-199203000-00006.

    PubMed 1564021

  • 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.

  • 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.

    PubMed 28857440

  • 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.

    PubMed 29937620

  • Abrahamse ME, Junger M, Leijten PH, Lindeboom R, Boer F, Lindauer RJ. Psychometric Properties of the Dutch Eyberg Child Behavior Inventory (ECBI) in a Community Sample and a Multi-Ethnic Clinical Sample. J Psychopathol Behav Assess. 2015;37(4):679-691. doi: 10.1007/s10862-015-9482-1. Epub 2015 Mar 25.

    PubMed 26640320

  • Fabiano GA, Pelham WE Jr, Waschbusch DA, Gnagy EM, Lahey BB, Chronis AM, Onyango AN, Kipp H, Lopez-Williams A, Burrows-Maclean L. A practical measure of impairment: psychometric properties of the impairment rating scale in samples of children with attention deficit hyperactivity disorder and two school-based samples. J Clin Child Adolesc Psychol. 2006 Sep;35(3):369-85. doi: 10.1207/s15374424jccp3503_3.

    PubMed 16836475

  • 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.

  • 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

  • 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.

    PubMed 31614051

  • 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.

    PubMed 18991983

Questions about this trial

What is this clinical trial studying?

A study testing Brief behavioral parent training in people with ADHD and ADHD - Combined Type, run by Accare at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in daily ratings of target behaviors by ecological momentary assessment (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05452954, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.

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