Clinical trial NCT01393691: A Clinical Research Studying Interventions for Nighttime Fears in Preschool Children
Official title: Interventions for Nighttime Fears in Preschool Children: Assessment of Predictors and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nighttime Fears
Keywords: nighttime fears
anxiety
sleep
actigraphy
intervention
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: nighttime fear and sleep logs
timeFrame: 1 week- 6 months
measure: Nighttime fears interview (child) and nighttime fears questionnaire (parents)
timeFrame: 1 week -6months
Secondary outcomes:
measure: Activity-based sleep monitoring (Actigraphy)
timeFrame: 1 week- 6 months
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Tel Aviv University; Schneider Children's Medical Center of Israel
name: Avi Sadeh, Prof.
role: STUDY_DIRECTOR
References: