Primary intervention objective: to evaluate change in emotion dysregulation in at-risk-for-ADHD toddlers (24-36 months) during the 8-week intervention period of MASTER compared to the 6-week baseline (control) period. Secondary intervention…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary intervention parameter: pre-post training change in toddler*s emotion
dysregulation as measured with EDI-YC.
Secondary outcome
Secondary outcome measures include child and parent functioning as well as
parent-child interaction measures. Moreover, we will explore possible
mitigating effects on ADHD symptoms at 4.5 and 6.5 years of age as measured
with the CBCL and the ADHD section of the DIPA diagnostic interview.
Additionally, we will investigate whether changes in ED symptoms in the one
parent, predict changes in ED in the other parent.
Background summary
Children of parents with mental Illness (COPMI) have an increased risk of
developing mental health problems themselves. Several mechanisms contribute to
this intergenerational transmission of mental health problems. One of the most
prevalent mechanisms are intense emotional interaction patterns in which the
parent does not succeed in regulating his/her own emotions and those of the
child. Instead, the parent may overreact (expressing intense emotions, i.e.
yelling, crying, panicking) or underreact (ignoring the child while present,
leaving the child alone). These emotional dysregulated (ED) interaction
patterns are more common in parents with mental health problems and often begin
in infancy or toddlerhood when the pre-verbal child communicates primarily by
expressing emotions. Parent-child interaction interventions have proven to be
effective in alleviating these ED-interaction patterns. Moreover, several
studies reported positive longer-term cascading effects for child development,
parental quality of life and family functioning. In the Netherlands,
parent-child interaction interventions in primary care are available for COPMI
of 0-1 year and 4 years and older, but not for COPMI of 2-3 years of age
(https://richtlijnenjeugdhulp.nl/kopp/inzetten-van-interventies/overzicht-van-in
terventies/). Only after problems have escalated, which is particularly risky
for this group, intervention can be offered in specialized care. Therefore, we
have developed MASTER: a parent-child interaction training for 1st line care
for COPMI of 2 and 3 years old. For the current study, the training will be
offered to parent(s) with ADHD that have a toddler that frequently expresses
intense emotions. ED parent child interactions are particularly common in this
target group and may contribute to the toddlers* risk of developing ADHD or
related problems. As such, early intervention strengthening emotion regulation
is expected to improve emotion regulation and potentially mitigate the
development of (severe) ADHD.
Study objective
Primary intervention objective: to evaluate change in emotion dysregulation in
at-risk-for-ADHD toddlers (24-36 months) during the 8-week intervention period
of MASTER compared to the 6-week baseline (control) period. Secondary
intervention objectives: to evaluate (child, parent and intervention predictors
of) change in secondary outcomes during the 8-week intervention period compared
to the 6-week baseline (control) period; to evaluate (child, parent and
intervention predictors of) change in the primary outcome and secondary
outcomes at follow-up (2 months and 1-year). Primary mitigating objective: to
evaluate whether the degree of ADHD symptoms at 4.5 and 6.5 years of age is
different for MASTER-participants compared to that of matched participants in
the prospective cohort study ROAD; Secondary mitigating objective: to evaluate
whether the prevalence of a research diagnosis ADHD at 4.5 and 6.5 years of age
is different for MASTER-participants compared to that of matched participants
in the prospective cohort study ROAD; Tertiary objective: to evaluate (child,
parent and intervention predictors of) change in the primary outcome and
secondary outcomes at 4.5 and 6.5 years of age.
Study design
An 8-week pre-post intervention design with a 6-week baseline period is used to
evaluate change in the outcomes of interest. Follow-up assessments take place
at 2 months and 1 year after the post training assessment. 1:1 randomization is
used to determine which parent participates in the training. In addition, 1:1
randomization is used to determine the training delivery method (MASTER-1 or
MASTER-2). Non-randomized, matched-sample comparisons will be made with
participants from a prospective cohort study (ROAD) to evaluate long-term
outcomes at 4,5 and 6,5 years of age.
Intervention
MASTER aims to improve the toddler*s emotion regulation problems through
strengthening parental emotion regulation knowledge and skills. The MASTER
training is designed for 1st line care, being relatively short (8-sessions) and
delivered by University of Applied Sciences (HBO in the Netherlands) level
trained therapists. MASTER is based on the most important elements of effective
treatments in parent-based trainings for older children: practice-based,
stimulating positive parent-child interactions and increasing parental
emotional communication and regulation skills. Two versions of the training
have been developed (MASTER-1: parent-therapist sessions with practices for the
home situation; MASTER-2: parent-child-therapist sessions with practices with
guidance of the therapist).
Study burden and risks
Participants receive regular forms of therapy and participate in interviews/
questionnaires. The risks are negligible and the extra burden is minimal.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
• Child's age at enrollment 24-36 months;
• Child has a substantially elevated level of emotion dysregulation
(normatively highest 30%) as measured with the EDI-YC (>=8) by at least one of
the parents;
• At least one of the biological parents has been diagnosed with ADHD and is
still experiencing clinical levels of ADHD symptoms or is under active
treatment for the ADHD symptoms.
• Both parents are willing to participate in the intervention.
Exclusion criteria
The following exclusion criteria will applied:
• Presence of emotion regulation problems that are so severe (ED-YC >= 19, which
represent scores more than 2 SD*s higher than the general population) that
complex developmental and behavioral problems are present. The child is better
helped with more intensive specialist care;
• Parent(s) suffer(s) from a disorder that severely limits the capacity to take
part in the intervention, e.g. meeting DSM-5 criteria for schizophrenia,
psychosis, or severe depression (as indicated by a score of >= 20 on the PHQ-9).
In this case the family is better helped when the parent is referred to
specialized care;
• Insufficient parent capacity as caused by one or more of the following
problems: financial uncertainty, housing, health problems. The family is better
helped by a broader approach provided by the municipality;
• The presence of a concerning parenting situation where there is a supervision
order for the child or a trajectory for a supervision order is ongoing;
• Current treatment in specialized mental healthcare because of concerns
regarding the child*s development or attachment to parents
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 | NL85712.000.23 |