The objective of this study is to develop an effective behavioural treatment for severe drooling. The hypotheses are:1. A behavioural program containing instruction, goal setting, positive practice, self-management techniques, and positive and…
ID
Source
Brief title
Condition
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Reviews on the management of drooling unanimously conclude that behavioural
treatment should be used before medication or surgery is considered. However,
scientific evaluation of behaviour therapy for drooling is scarce: from 1970 to
2005, only 17 articles have been published, containing experimental data of
only 53 patients. As a consequence, there is neither *evidence based*
behavioural treatment nor *best practice* for drooling.
Study objective
The objective of this study is to develop an effective behavioural treatment
for severe drooling. The hypotheses are:
1. A behavioural program containing instruction, goal setting, positive
practice, self-management techniques, and positive and negative social
reinforcement, leads to a reduction of drooling while the subject is performing
daily activities in a one-to-one training.
2. The results generalize to natural settings at home and at school.
Study design
In a non-concurrent multiple baseline design across subjects (Watson & Workman,
1981) intervention is started after baseline. Once the training goal is
reached, post treatment data are collected. Immediately after discharge,
generalisation data are collected at school. After 6 and 24 weeks follow up
data are collected.
Intervention
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.
During the training program the child learns to keep the mouth and chin dry and
clean with increasing time-intervals while performing their daily activities.
The initial demanded intervals are 1, 2, 5, 10, 15, 20, 25, 30 minutes. After
being dry for half an hour, time intervals are increased either with 5, 10 or
15 minutes, depending on the learning potential of the child.
Before training starts, the child is told that drooling is not good, because it
makes you look bad. The child is convinced that other people don*t like the
sight of drooling and he/she will be trained to swallow and wipe more often to
prevent drooling. The training format is explained and a swallowing report on
which stickers can be attached is introduced.
The time interval for the first training sessions is determined from baseline
latency recordings. This is the interval that the child usually is able to stay
dry during activity.
The training starts with instruction, positive practice, self-instruction,
positive feedback for target behaviours and the introduction of the activity
and the time interval. Whenever the child succeeds to stay dry during the
entire interval, positive social reinforcement is given and a sticker is put in
the swallowing report. If the child does not succeed, the activity is
interrupted and the child is told that he/she has not succeeded the interval.
Incidentally, a negative remark is added. The child is prompted to clean
his/her face and a new trial is started. When the child succeeds at three
successive trials, the next larger time interval is trained. When the child
does not succeed three successive trials or three out of five trials, training
is reinstated on the one step lower time-interval.
Study burden and risks
After inclusion the child is admitted to the clinical department of a
rehabilitation centre during 3 weeks (except the weekends). Parents are offered
the posibility of roomin-in. Parents and teachers fill in a questionnaire
before intervention and at follow up at 6 and 24 weeks. In addition, they
complete two ratingscales on drooling severity for 10 days. We will kindly ask
hospitality for generalisation and follow-up recordings at the child's school.
There are no physical risks associated with participation. Psychological burden
(homesickness, tiredness, disappointment or anger if not succesful) is
carefully observed and discussed with the parents.
Hengstdal 3
6522 JV Nijmegen
Nederland
Hengstdal 3
6522 JV Nijmegen
Nederland
Listed location countries
Age
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
· 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
Recruitment
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 |
|---|---|
| CCMO | NL14497.091.06 |