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The development and evaluation of a behavioural program to treat drooling in children wit Cerebral Palsy

The development and evaluation of a behavioural program to treat drooling in children wit Cerebral Palsy - Behaviour therapy for drooling in CP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30394
Enrollment
20
Registered
2007-06-12
Start date
2006-10-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral palsy

Interventions

The study is conducted in the clinical department of a rehabilitation centre, where participants are admitted during 3 weeks. During intervention three 1*- hour training sessions are scheduled daily.

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: · a confirmed diagnosis of CP, with detailed descriptions of movement impairment; · drooling severity: Teacher Drool Scale (TDS: Camp-Bruno et al., 1989) score 3 (occasional drooling; intermittent all day) or more (4: frequent drooling; but not profuse; 5: constant drooling; always wet); · developmental age >= 6 years; the child displays reasonable awareness of the practical and/or social consequences of drooling; · the child has the ability to close his/her mouth and swallow on demand; · the child has the ability to remain seated (or is able to correct seating position independently); · the child has the ability to wipe the mouth/chin; · the child is susceptible to social and/or material reinforcers; · medication to treat drooling stopped at least 3 months before inclusion; · the parents and teachers are willing to participate in the treatment program, i.e. to perform activities to maintain the training effect. · the child and their parents and teachers are willing to participate in scientific research, including activities for data-collection (informed consent is obtained) and if significant positive changes are established are prepared to refrain from other medical treatment for 6 months after the end of the training.

Exclusion criteria

Exclusion criteria: · the child has uncontrollable (epileptic) seizures; · the child has severe aggressive or hyperactive behaviour; · during 6 months before inclusion there has been surgery or botulinum toxin injection

Design outcomes

Primary

MeasureTime frame
At baseline at least 10 or more 10-minute video recordings are made while the child is engaged in different daily activities such as watching television, playing a game, doing schoolwork, etcetera. Dependent measures are: A) Drooling. Drooling behaviour is scored at two levels: 1. Latency recording: minutes/seconds the child manages to stay dry after the start of the activity. 2. Drooling severity: partial interval time-sampling during 40 intervals of 15 seconds with four categories: (a) new saliva below lower lip line, (b) old saliva below lower lip line, (c) string of dribble or (d) dry. B) Wiping. The frequency of spontaneous wiping during 10 minute-sessions is scored. During the training period post-tests for latency are scheduled at the end of each training session. When the 30-minutes interval is reached successfully, post-tests are only scheduled at the end of the last training session every day. In addition, to assess whether the training effects remain overnight, the first training session starts with a delayed post-test of latency. At the end of the training period at least another 10 or more 10-minute video recordings are made while the child is engaged in different daily activities. During generalisation and follow-up sessions drooling is only assessed with latency recording. Interobserver reliability is determined for 10% of the video-recordings.

Secondary

MeasureTime frame
In addition to quantitative measures from behaviour observation, parents and teachers are asked to rate drooling severity on the TDS and a VAS for ten consecutive days before baseline-recordings and during follow-up periods. In addition, parents and teachers fill in questionnaires on practical, social and emotional consequences of drooling (Van der Burg et al., 2006) before baseline, during generalisation and follow-up periods.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)