Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04978844 |
| Other study ID # |
Inner World of the Child |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
April 1, 2026 |
Study information
| Verified date |
March 2024 |
| Source |
Interdisciplinary Center Herzliya |
| Contact |
Yael Apter Levy, Phd |
| Phone |
+972546441350 |
| Email |
yaelmapter[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study will comprise of three groups of children (n=40): 1. A group receiving a novel
short-term dynamic play therapy. 2. Dyadic therapy 3. Control group who will not receive
therapy. All children will be assessed for psychopathology (anxiety, depression and
behavioral problems) using standardized instruments such as semi-structured interview and
self-reported questionnaires; EEG recordings will be performed from child and parents in
order to asses brain synchrony; Cortisol (CT), Dehydroepiandrosterone (DHEA), Oxytocin (OT)
and Secretory Immunoglobulin A (SIgA) will be assessed by using saliva sampling; and
father-mother-child interactions will be videotaped and analyzed. Narrative descriptions will
be obtained from parents, and the interviews recorded for voice analysis. Assessment will be
made at baseline and then bi-monthly for six months.
Description:
Anxiety disorders are the most common disorders across the lifespan and tend to have both an
early onset and persistent course throughout life. Since the preschool years mark a sensitive
period for the development and exacerbation of anxiety symptoms in children, which often
persist throughout childhood and adolescence, there is an urgent need to understand this
condition in the most detailed manner and find efficient therapeutic solutions. In this
Randomized control study (RCT), the investigators will test the efficacy of two interventions
for childhood anxiety disorders: a special emotion-focused therapy and a dyadic parent-child
intervention.
DESGIN Recruitment: consecutive admissions to the preschool clinic at the Intradisciplinary
Center at Herzliya will be asked to participate in the study.
Baseline Diagnosis:
1. Psychiatric diagnosis: will be made by using a combination and integration of the
childhood version of the Schedule for Schizophrenia and Affective Disorders (K-SADS-PL)
and the Preschool Age Psychiatric Assessment (PAPA). Diagnosis will be made according to
the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) and Diagnostic
Classification of Mental Health and Developmental Disorders of Infancy and Early
Childhood (DC 0-5). These semi-structured interviews will be conducted by a clinical
psychologist with a special expertise in evaluation and treatment in preschool children
(YAL). All diagnoses will then be checked with a senior child and adolescent
psychiatrist.
2. Behavioral profiles: The Child Behavioral Checklist for preschoolers will be
administered to parents and will generate behavioral profiles adjusted for gender.
Randomization:
Consecutive referrals to the clinic will be recruited for the study and will be randomly and
blindly allotted to each treatment arm.
Therapy:
Both therapies would have the same duration of 6 months and will consist of 24 weekly
meetings for the child or child-parent dyad, accompanied by 12 bi-weekly meetings with both
parents. Each session will last for approximately 50 min.
1. Inner World of the Child I-WotCH- - is a novel innovative therapy developed in our
clinic. The therapy is based on modern concepts of early childhood developments
emphasizing themes related to emotional regulation, processes of socialization,
observational research on interpersonal and behavior as well as recent developments on
affiliative neuroscience. More specifically, the therapist, through play, identifies
themes and emotions the child is preoccupied with. The therapist then assists the child
in naming these emotions, validating them, exploring their nature and consequences. The
therapist discusses ways of managing and self-regulating these emotions through methods
that include behavioral techniques, the ability to enlist help from others, and
reframing. In addition, the therapy will address ways of dealing with complex emotions
and enhancing symbolic play and joyfulness
2. Child-parent psychotherapy- CPP: CPP consists of joint parent-child sessions that focus
on the child's free play and spontaneous parent-child interaction. The CPP therapist
acts to "translate" the developmental and emotional meaning of a child's emotions and
actions to the parent. The target of treatment includes the both the child's and the
caregiver's adaptive conflicts, including a parent's difficulty in providing sensitive
and developmentally appropriate care. CPP fosters parent-child activities that foster
mutual pleasure, interpersonal trust and understanding. In the purpose of this study
only mothers will be included.
EVALUATION All children will be evaluated at baseline, at bi-monthly intervals during
treatment, and at termination (at 6 months). The evaluation session will be conducted in a
university laboratory (not in the clinical setting) by RA unfamiliar to the child.
Dropouts will be noted and as far as possible the details for discontinuing will be recoded.
1. Psychopathology (as noted above):
1. Psychiatric diagnosis: will be made by using a combination and integration of the
K-SADS-PL and the PAPA. Diagnosis will be made according to the DSM-5 and DC 0-5.
2. Behavioral profiles: The Child Behavioral Checklist for preschoolers will be
administered to parents.
2. Parent-Child Relationship:
1. Parent-Child Social Interactions: each five minutes of mother-child, father-child and
triadic interactions with pre-selected toys will be videotaped. Dyadic interaction will
include free play and a challenging task. Interactions will be coded with the Coding
Interactive Behavior manual. The CIB is a global rating system for analyzing social
interactions between two or more partners. The CIB comprises five manuals: newborns,
infants, preschoolers, adolescents/ adults, and the recently added psychotherapy manual,
all based on the same constructs with good psychometric properties. The CIB utilizes a
variety of social settings and observational paradigms (e.g., free play, feeding,
conflict discussion, triadic/family interactions) and has been used in hundreds of
published studies in healthy and high-risk populations and clinical trials.
The following dimensions will be emphasized:
1. Iintrusiveness- this measures the degree to which the parent interferes with the
child's natural behavior throughout the session, for instance, ignoring the child's
signals, overriding the child's cues and wishes.
2. Reciprocity: this measures the degree to which the parent and child interact in a
mutual fashion.
3. Acknowledgment: this scale is a central feature of sensitive parenting. this
measures the degree to which the parent is aware and sensitive to child's signals
and expresses them both vocally and by gesture.
4. Avoidance- this measures the degree to which the child avoids the parent and
retreats from the parent's attempts to engage him.
5. Positive and negative affect: this measures the degree to which the parent
expresses positive or negative emotions towards the child.
In addition, other dimensions will also be noted and scored, as listed in the CIB
manual.
2. Mother-Father Relationship: five minutes of Conflictual Discussion between and father
will be videotaped and coded.
3. Child Emotion Regulation: the child's ability to regulate his emotions will be rated
using the child's reaction to a challenging task, such as the puzzle task. Micro-coding
of child behavior during the puzzle task paradigm will be conducted on a computerized
system (Noldus Co, Waggeniggen, The Netherlands). Codes are based on our own and others'
research with preschoolers . Child's Self-Regulation will be represented by the sum of
time proportions of each of the following behaviors: withdrawal, gaze aversion, physical
self-soothing and solitary substitutive play.
In addition, parents will fill out the Toddler Behavior Assessment Questionnaire (TBAQ),
. This questionnaire includes the assessment of child's temperament, emotion regulation,
self-soothing and inhibition control.
4. Parental Representation of Child and the Treatment: Narrative descriptions will be
obtained from parents, and the interviews recorded for voice analysis. Parents will
answer three questions: 1. "Describe your child"; 2. "Describe your child's problems";
3. "How do you think the therapy will help addressing your child's difficulties".
5. Biological Measures:
1. Hormonal Measures: Saliva will be obtained for the following measure for both parents
and child: OT, CT and DHEA (DHEA from parents only).
OT: Oxytocin is a hormone which appears to be a marker of affiliation and relationship.
It has been shown to be disturbed in conditions where parent-child relationships are
impaired.
CT: is a well known and much studied marker of stress and anxiety. DHEA: this hormone
has also been shown by our group and others to be related to stress and emotional
regulation.
Hormonal Analysis:
OT: The liquid samples will be stored at 80ºC. To concentrate samples by 3 or 4 times,
the liquid samples would be lyophilized over-night and kept in 20ºC until assayed. Dry
samples will be reconstructed in the assay buffer immediately before analysis by EIA.
Determination of OT was performed by commercial OT ELISA kit (Assay Design, MI, USA).
CT: The samples will be stored at -20°C until assayed. Cortisol levels will be assayed
using a commercial ELISA kit (Assay Design, MI).
DHEA: In-order to precipitate the saliva, samples will undergo several freeze-thaw
cycles. After the fourth cycle the tubes will be centrifuged at 1500 x g (@3000 rpm) for
20 minutes. Supernatants will be stored at -20°C until assayed. Determination of DHEA
will be performed using a commercial DHEA ELISA kit (Salimetrics, USA). Salimetrics DHEA
kit is a competitive immunoassay specifically designed for the quantitative measurement
of salivary DHEA. On the day of assay, samples will be thawed, and 50 micro-liters will
pipette into the appropriate well of the kit.
Immunological measures:
SIgA: there is a strong relationship between the immunological system and stress. the
investigators will therefore assay SIgA, which has also been studied in stressful
situations.
Immunological measure analysis:
Determination of s-IgA will be performed using a commercial s-IgA ELISA kit (EUROIMMUN
AG: 23560, Luebeck, Germany). The kit provides quantitative in vitro assay for s-IgA in
human saliva. On day of assay, samples will be thawed completely and diluted 1:201 in
sample buffer and further measured according the kit's instructions. Measurements were
performed in duplicate and the concentrations of samples were calculated by using matrix
laboratory (MATLAB 7) according to relevant standard curves. The intra-assay coefficient
of samples and controls was 8.1%, and inter-assay coefficients for samples and controls
were less than 11.6%.
Electrophysiological measure:
EEG recordings will be performed on the first and final visit. Children and parents will
be given an EEG helmet from which multiple scalp readings will be taken.
Statistics all variables will be entered into a data base and then into SPSS. The major
hypothesis will be the relative efficacy of the two interventions would be compared to
control, evaluating symptoms reduction, hormonal level changes and enhancing parental
sensitivity (among other changes in parental behavior). The investigators will perform
variance analysis, correlations, regression and HLM models that will describe the
changes in these variables in each group (two intervention and one control) along the
check up points (baseline, every two months and at ending point).
