Nighttime Fears Clinical Trial
Official title:
Interventions for Nighttime Fears in Preschool Children: Assessment of Predictors and Outcomes
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment