Main objective: to test the effectiveness of KOO-PTSD on parenting skills at the macro- and micro-level.Secondary objectives: to test the effectiveness of KOO-PTSD on perceived parenting competence, social support, parenting stress, child…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are parenting behavior at the macro- and micro-level.
Secondary outcome
Secundary study parameters are sense of parenting competence, social support,
parenting stress, psychosocial wellbeing of the child, and PTSD symptoms of the
child.
The following variables are also measured: parental PTSD symptoms, trauma
type/timing, psychosocial functioning, demographic information of the parent
and child, number of completed modules/sessions, number of interactions with
PTSD-specific online intervention content, satisfaction with the intervention,
sleep quality, situational context, and distress level.
Background summary
Children of parents with post-traumatic stress disorder (PTSD) are at increased
risk of mental health problems, such as depression, anxiety and hyperactivity.
They are also more likely than children of healthy parents to be exposed to
potential trauma, especially in the family setting (e.g., child maltreatment).
Parents with PTSD often experience difficulties in their parenting role (e.g.,
deficits in effective parenting, sense of parenting incompetence, lack of
social support). Research in other mental disorders shows that preventively
supporting parents with mental illness in their parenting role decreases mental
health problems in children. As of yet, no preventive intervention specifically
aimed at parents with PTSD exist. We will therefore adapt an existing
preventive online course for parents with mental illness, *KopOpOuders
zelfhulp*, into a blended care intervention for parents with PTSD: *KopOpOuders
for PTSD* (KOO-PTSD).
Study objective
Main objective: to test the effectiveness of KOO-PTSD on parenting skills at
the macro- and micro-level.
Secondary objectives: to test the effectiveness of KOO-PTSD on perceived
parenting competence, social support, parenting stress, child psychological
wellbeing, and child PTSD symptoms; to test whether intervention effects are
moderated by baseline PTSD symptoms; and whether patterns can be detected in
fluctuations of PTSD symptoms and hostile-coercive/supportive-engaged parenting
throughout the day and week.
Study design
The study uses a single-blind randomized controlled trial design with three
measurement points (pretest, posttest, and follow-up). Data are collected
through self-report questionnaires and, for participants who agree to this,
with ecological momentary assessment (EMA) using a smartphone app.
Intervention
The intervention group receives KOO-PTSD, consisting of 5 online modules and 3
face-to-face sessions, in addition to treatment as usual. The control group
does not receive intervention apart from treatment as usual, but can access the
online modules of KOO-PTSD after participation.
Study burden and risks
Participants are asked to meet three times with a researcher (online or in
person) to complete questionnaires. Participants will also be asked if they
want to participate in the EMA component. This is optional. The EMA component
comprises the completion of three brief EMA assessments per day during a week
each after pretest and posttest (42 assessments in total). Participants in the
intervention condition complete eight sessions, five online and five
face-to-face. The total estimated time investment for the intervention group is
12.3 hours (no EMA)/ 15 hours (EMA), and for the control group 2.7 hours (no
EMA) / 5.5 hours (EMA). Participation may result in some psychological
discomfort (e.g. some questions may be experienced as confronting), but no
medical or physical risk is associated with participation.
Laan van de Helende Meesters 2
Amstelveen 1186 AM
NL
Laan van de Helende Meesters 2
Amstelveen 1186 AM
NL
Listed location countries
Age
Inclusion criteria
• Has current DSM-5 diagnosis of PTSD;
• Is receiving PTSD treatment of at least three sessions at one of the
following Arkin departments: Sinai Centrum, Jellinek, Punt P, NPI, or Arkin
BasisGGZ;
• Has parenting responsibilities for at least one child aged 4-17 (biological
or legal relationship not required);
Exclusion criteria
• Has urgent care needs or (imminent) crisis (e.g. current psychosis, substance
detoxification, active suicidality);
• Is not in contact with children (e.g. due to out of home placement)
• Is receiving another form of parenting intervention during the participation
period;
• Severe psychological problems are present in children (diagnosis of
oppositional-defiant disorder, conduct disorder, psychotic spectrum disorder or
personality disorder);
• Inability to participate in the intervention and/or assessments (e.g.,
because of mental disability (IQ < 75) illiteracy, or insufficient mastery of
the Dutch language).
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 |
|---|---|
| ClinicalTrials.gov | NCT05237999 |
| CCMO | NL78891.041.21 |