SPACE: an innovative parent treatment for children with obsessive-compulsive disorder

(Also see METC- protocol)

Obsessive-compulsive disorder (OCD) is a prevalent mental disorder, affecting
0.5-2% of children and 2-3% of adults. With OCD, children experience anxiety or
distress-provoking intrusive thoughts (obsessions) and/or time-consuming
ritualistic behaviours (compulsions), that significantly impair daily life and
family functioning. OCD is characterized by early childhood onset (>50% of
patients suffer from symptoms at childhood, adolescence or early adulthood),
late recognition of symptoms delayed start of treatment, and, if not treated, a
chronic disabling disease course. First-line treatment options are cognitive
behavioural therapy (CBT) and pharmacotherapy (especially selective serotonin
reuptake inhibitors; SSRI*s, that have a treatment response of approximately
60%. In addition, there are also patients (19%) that never get treated, because
of lack of motivation or too high levels of anxiety, withholding them from
treatment or leading to early drop-out. More and additional treatments for
these patients are therefore highly needed.
Several factors have been identified as predictors and moderators of treatment
response in paediatric OCD. For children with a family history of OCD, CBT
monotherapy was not effective, for children with OCD and comorbid tics, CBT was
effective but pharmacotherapy was not, and furthermore, symptoms severity,
impairment, older age, comorbidity and family accommodation are found to be
predictors of outcome of CBT.
Family accommodation (FA) is an under-addresseds aspect of OCD and anxiety in
children and adolescents. It can be described as all behaviours of parents,
siblings and other caregivers to alleviate distress in the affected child. High
family accommodation is associated with greater severity of symptoms, poorer
functioning and poorer treatment outcomes in children and adolescents. FA is
highly prevalent in families of children with OCD and other anxiety problems,
and is significantly elevated compared to families without anxious children.
To bridge a gap in the treatment of OCD and anxiety, Lebowitz and colleagues
developed an innovative parent-based treatment (parent stand-alone treatment)
targeting family accommodation to children*s anxiety and/or OCD. Supportive
Parenting for Anxious Childhood Emotions (SPACE) is a manualized, completely
parent-based, treatment program. FA is the central focus of the treatment.
Parents are taught to reduce their FA and to increase their supportive
responses to their child. To empower parents to make these changes, SPACE
translates and applies principles of non-violent resistance (NVR), originally
developed for working with children with externalizing problems.
A unique advantage of the program is that SPACE can be applied without
cooperation of the child, so for families of children that are reluctant or not
motivated to participate in treatment or do not respond sufficiently to CBT.
Therefore, SPACE provides an additional treatment option for families of
children with OCD and anxiety.

(Also see METC- protocol)

Primary Objective:
To investigate the effectiveness of the SPACE treatment to improve family
accommodation and OCD symptoms.

Secondary Objective:
To explore mechanisms of change (in OCD symptoms) for the effectiveness of the
SPACE treatment.

(Also see METC- protocol)

The current study will use a single-case experimental design (SCED) with
multiple baselines. 25 children with OCD, both their parents and their teacher
will be included in the study. Therefore, the target number of participants in
the study amounts to 100 participants. Participants will be randomized to one
of three possibilities to start with SPACE (4, 6 or 8 weeks after the baseline
assessment). Although treatment is not initiated yet, in these baseline
periods, short assessments (three time per week) will be carried out.

Measurements during the period from T1 to T5:
- Three times per week short assessment on family accomodation and OCD
-symptoms
- Per weekly treatmentsession a score by parents on the Outcome Rating Scale
(ORS) and the Session Rating Scale (SRS), and an overall impression of the
clinician (CGI).
- At 6 time points FA (FASA,FASA-CR and CD-POC) and OCS severity (CYBOCS): T0
(start); T1 (start of treatment: 4, 6 or 8 weeks after T0); T2 (after 4
treatment sessions), T3 (after 8 treatment sessions) T4 (end of treatment, 12
weeks), T5 Follow-up (6 months after start of treatment T1).
- General psychopathology and comorbidity, quality of life, motivation,
parental burden at baseline T0, after treatment T4 and at follow-up T5.

(Also see METC- protocol)

The SPACE program is a parent stand-alone treatment, so the child will not
participate in treatment. It consists of 12 weekly, 60-minute sessions. The
current study will use the published SPACE protocol and modified for Dutch
speaking families.

The risks associated with participation in the study are negligible.

Research load (See also METC protocol).

For children:
The total study load is approximately 6 hours divided over 6 assessments:
- T0: approx. 35 min
- T1: approx. 65 min
- T2: approx. 30 min
- T3: approx. 30 min
- T4: approx. 90 min
- T5: approx. 90 min (follow-up)
- Frequent measure: In addition, three times per week 2 1-minute questions will
be answered for the total duration of the study.

For parents:
The total burden for the study is 12 hours treatment sessions + approx. 6 hours
assessments divided over 6 assessments. The load for the study at the different
measurement times is as follows.
- T0: approx. 35 min
- T1: approx. 30 min
- T2: approx. 30 min
- T3: approx. 30 min
- T4: approx. 90 min
- T5: ca. 85 min (follow-up)
- Frequent measure: In addition, three times per week 2 questions of 1 minute
are answered for the duration of the study.
- Before and after each treatment session: 2 1-minute questions will be
completed. (SRS/ORS).

For teachers:
The digital questionnaire for the teacher will take approx. 20 minutes at T4
and T5 and is part of care as usual at T0

For therapist:
- Weekly after each treatment session: therapist answer a 1 minute question
(CGI)