Nighttime Fears Clinical Trial
Official title:
Interventions for Nighttime Fears in Preschool Children: Assessment of Predictors and Outcomes
| Verified date | July 2015 |
| Source | Rabin Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ethics Commission |
| Study type | Interventional |
Nighttime fears (NTF) and sleep disruptions in preschool children continue to be major
problems in clinical services. The aim of this study is to test the efficacy of two
interventions designed for preschool children suffering from NTF: (a) a CBT adaptation
combining parent involved play, which will include multiple standard cognitive-behavioral
techniques, namely psycho-education, problem solving via play, gradual exposure and
reinforcement management; and (b) Triadic Expressive Play Therapy, based on Virginia
Axline's (1947) eight basic principles of play therapy. Parents will take an active part
both in and in between treatment sessions in both intervention groups. In addition to the
review of the outcomes of these interventions, the proposed study aims to identify variables
that moderate and mediate treatment effects.
In an attempt to meet these aims, the investigators will recruit 90 children suffering
severe NTF and their parents who seek treatment. At baseline the investigators will assess
children's NTF and general fears, sleep patterns and disruptions, behavior problems and
potential moderators (i.e. playfulness, oppositionality, desire for control and parental
anxiety). Assessment will be based on both objective and subjective measures, including
interviews with the child and parents, questionnaires and actigraphy. The investigators will
then randomly assign these children to one of two conditions: CBT with parent involved play
or Triadic expressive play therapy. Possible mediators (i.e. the therapeutic alliance,
patient compliance, motivation etc.) will be evaluated after each of the active intervention
sessions. The effects of the interventions will be assessed by comparing four time points:
baseline, first week of intervention, 1 month and 6 months subsequent to administration.
The main hypotheses of the proposed study are: (a) A positive correlation will be found
between the severity of NTF and the severity of sleep disruption at baseline, and a
reduction in NTF will be associated with an improvement in sleep; (b) Both interventions
will significantly reduce nighttime fears, but greater impact will be evident in the CBT
group; (c) Higher levels of playfulness and lower levels of oppositionality and desire for
control, as well as parental anxiety will predict desirable outcomes. (d) Stronger
therapeutic alliances, in addition to higher levels of motivation and compliance will be
associated with greater intervention effectiveness.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 6 Years |
| Eligibility |
Inclusion Criteria: - NTF exist for a minimum of 2 months, with significant adverse impact on the child and the family, requiring parental involvement for at least two nights per week to comfort the child. Exclusion Criteria: - major health or neurological-developmental problems - concurrent psychiatric treatment - concurrent psychotherapy or any other intervention aimed at reducing the child's nighttime fears. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rabin Medical Center | Petach Tikva |
| Lead Sponsor | Collaborator |
|---|---|
| alan apter |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | nighttime fear and sleep logs | Parents will be asked to report the level of their child's fear in the fear diary every night after bedtime, and every morning after the child has awoken from slumber. In addition, they will be asked to document the influence fears had on their child's sleep and bedtime routine, and the coping strategies that were implemented by themselves and by their child during the night. | 1 week- 6 months | No |
| Primary | Nighttime fears interview (child) and nighttime fears questionnaire (parents) | Children will be interviewed regarding the content, frequency and severity of their nighttime fears. Parents will complete a questionnaire regarding these issues. | 1 week -6months | No |
| Secondary | Activity-based sleep monitoring (Actigraphy) | The actigraph is a wristwatch-like device attached to the child's wrist, which enables continuous recording of the child's movements for extended periods, with no interference with the child's natural sleep environment. The following actigraphic sleep measures will be included in this study: (a) sleep onset time (b) total sleep duration from sleep onset to morning rising time; (c) morning rising time; (d) sleep percentage; (e) true sleep time; and (f) number of night-wakings. |
1 week- 6 months | No |