No registrations found.
ID
Source
Brief title
Health condition
Day-time urinary incontinence (DUI) and non-retentive faecal incontinence (NFI)
Sponsors and support
Intervention
Outcome measures
Primary outcome
self-initiated toileting and urinary/faecal accidents during treatment/post-intervention
Secondary outcome
self-initiated toileting and urinary/faecal accidents during follow-up.
Background summary
Children and adolescents with neurodevelopmental disabilities seldom attain continence for urine and faeces through maturation. One-to-one training is often needed to establish continence. There is international consensus about the use of least-to-most intrusive treatment procedures for children with Elimination Disorders (ED) with Standard Urotherapy (SU) being considered a first-line treatment. However, specific guidelines pertaining to additional low intrusive procedures, while still producing the desired effect of attaining continence, are lacking in the literature. Furthermore, few studies describe the content of SU interventions and the effectiveness of SU specifically pertaining to children and adolescents with neurodevelopmental disabilities (ND). This PhD study focusses on adhering to the least-to-most intrusive guidelines for treatment and determining the effectiveness of standard urotherapy, behavioural training procedures based on response restriction and video modelling for self-initiated toileting.
Research question
Is VM effective in attaining continence in children and adolescents? What is the effectiveness of an add-on RR training with prompting for children and adolescents with DUI and/or NFI, who do not attain self-initiated toileting with VW alone?
Participant characteristics and setting
Twelve participants (5-18 y) will participate in this study. The VM and RR training will be conducted in a therapy room, 3 x 3m, at SeysCentra. Adjacent to the therapy room is a toilet room, 1,5 x 1,5m. In the therapy room is a table, two chairs, and a cupboard.
Study design and group assignment
A non-concurrent multiple probe design across participants (Kazdin, 2011) will be used to investigate the effectiveness of VM and RR with prompting on DUI/NFI in participants.
Procedures
Informed consent of parents and child (>12 y) for this study will be obtained. After an intake procedure/assessment, the Dutch version of the Developmental Behaviour Checklist (i.e., vragenlijst voor ontwikkeling en gedrag [DBC-P], Einfeld, & Tonge, 2002), micturition lists and the Dutch version of the Vineland Adaptive Behaviour Scales (i.e., de VINELAND Screener, Sparrow, Carter, & Cicchetti, 2008; Scholte, et al., 2014) will be completed by the parents. The Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV-NL) or the Snijder-Oomen nonverbal intelligence test (SON-R) will be completed during the waitlist period for all participants. If an IQ test has been completed within the last two years, that score will be obtained for the parents due to reliability issues when conducting a new IQ-test within two years. For children who are unable to complete the entire IQ-test, the short version of the SON-R will suffice. In addition, parents will measure urinary/faecal accidents and self-initiated toileting habits at home during baseline for at least five probe sessions.
While on the waitlist, participants will be randomly assigned to either the treatment condition (SU) or the control group (study 6). At the end of baseline 1 (while remaining on the waitlist) participants assigned to the treatment condition will receive SU for 4 weeks. During a one-day training session at SeysCentra, the parents and child will receive SU training as indicated by the criteria mentioned by (Schäfer et al., 2018): (1) disorder specification (intake procedure), (2) give instructions to establish better micturition, (3) guidelines for fibre and fluid intake, (4) documentation of all symptoms (intake procedure), and (5) continuous monitoring by the researcher/therapist. During the following 4 weeks parents and the child will receive weekly follow-up phone calls from the treatment team in order to receive information and feedback about the training. If SU was not successful in attaining continence, additional treatment is warranted (Schäfer et al., 2018) and the participants will remain on the waitlist (baseline 2) until the start of cognitive-behavioural treatment at SeysCentra.
For an additional baseline after SU, parents will measure urinary/faecal accidents and self-initiated toileting at home during baseline 2 for a minimum of five probe sessions. Then, the participant will visit the training centre for three baseline sessions (phase A), measured by a therapist in order to exclude impeding effects of the training centre. Children will receive VM training given by a therapist at SeysCentra. During the training, an animated video modelling the target behaviour as described by McLay et al. (2015) will be utilized. Prior to each toileting occurrence the participants will be shown the video, modelling the target behaviour. Video modelling in the bathroom will focus on appropriate urination or defecation in the toilet (McLay et al., 2015). During the intervention (and baseline at SeysCentra) the participant visits the training centre for ten workdays (no weekends) from 9:00 AM to 3:00 PM for VM training. For participants who do not attain a predetermined criterion after five sessions of VM training (phase B), an RR training with prompting will be added (phase C) for an additional five sessions. Protocolized RR with prompting utilizing ABA procedures will be executed. Participants who met criteria after five training sessions during phase B, will continue the remaining sessions without the add-on training. After the training at SeysCentra for ten workdays, post-intervention in the natural environment will start. During post-intervention, parents will foster generalization in the natural environment (e.g., at home) of the participant. Parents will receive protocolled feedback and instruction. Post-intervention will end after a pre-set criterion will be reached or after ten weeks. Eight weeks following post-intervention, maintenance will be measured in the follow-up phase for three days. Parents will not receive any feedback or instructions during follow-up measurements.
Measures and materials
Parents will be asked to measure urinary/faecal accidents, self-initiated toileting habits at home for at least five probes during the baselines, post-intervention, and follow-up. Event recording during a morning session (9:00 AM-12:00PM) and afternoon session (12:00 PM – 3:00 PM) of urinary/faecal accidents and self-initiated toileting habits (rate per 3 hours) will be conducted. Data on procedural fidelity will be collected by an independent observer (i.e., research assistant) in 30% of all sessions across participants during the treatment phase. Interobserver agreement will be calculated using mean count per three hours. Procedural fidelity of VM and RR will be calculated per session based on the ratio of executed components versus planned components.
Study objective
VM results in a higher rate of self-initiated toileting and a decrease in urinary/faecal accidents. For children who do not attain continence with VM alone, an add-on training of RR with prompting will result in a higher rate of self-initiated toileting and a decrease in urinary/faecal accidents.
Study design
Rate of self-initiated toileting and urinary/faecal accidents at the end of:
- Baseline 1
- SU
- Baseline 2
- Intervention
- Post-intervention
- Follow-up
Intervention
Video-modelling (VM)
Response Restriction (RR) with prompting
Standard Urotherapy (SU)
Inclusion criteria
All participants meet the following inclusionary criteria: They (a) have DUI, assessment and diagnosis using ICCS criteria (von Gontard, 2013b; Austin et al., 2016), and/or (b) have NFI, assessment and diagnosis using Rome IV criteria (von Gontard, 2013a; Hyams et al., 2016), (c) underwent a paediatric examination (d) have an IQ ≥35, (e) have ability to stand and walk, have (f) no visual impairment, (g) have the ability to imitate, and (h) SU training at SeysCentra has already been conducted, and did not result in continence
Exclusion criteria
Participants will be excluded from this research study based on the following exclusion criteria: They (a) have an IQ ≤ 34, (b) are unable to stand or walk, (c) have a visual impairment, (d) are unable to imitate based on video modelling imitation probes, (e) do not have NFI or DUI or (f) received a completed SU training according to the ICCS criteria (von Gontard, 2013b) at a different facility, or (g) completed an SU training which was effective in attaining continence.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8969 |
Other | ECSW Radboud University : ECSW-2021-151R2 |