A Clinical Research Studying Interventions for Nighttime Fears in Preschool Children

NCT01393691 | Completed

• 1 other identifier: 6191
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Nighttime Fears

Keywords

nighttime fears; anxiety; sleep; actigraphy; intervention

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Activity-based sleep monitoring (Actigraphy)

  1 week- 6 months

Study Arms (2)

CBT with parent combined play

EXPERIMENTAL

This is a CBT adaptation designed for preschool children, which includes multiple standard cognitive-behavioral techniques, namely psycho-education, problem solving via play, gradual exposure and reinforcement management.

Behavioral: CBT with parent involved play

Triadic expressive play therapy

ACTIVE COMPARATOR

Based on expressive play therapy guidelines, children and their parents will express themes concerning bedtime routines and fears via play.

Behavioral: Triadic expressive play therapy

Interventions

CBT with parent involved play BEHAVIORAL

This is a CBT adaptation designed for preschool children, which includes multiple standard cognitive-behavioral techniques, namely psycho-education, problem solving via play, gradual exposure and reinforcement management.

CBT with parent combined play

Triadic expressive play therapy BEHAVIORAL

Based on expressive play therapy guidelines, children and their parents will express themes concerning bedtime routines and fears via play.

Triadic expressive play therapy

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• major health or neurological-developmental problems
• concurrent psychiatric treatment
• concurrent psychotherapy or any other intervention aimed at reducing the child's nighttime fears.

Sponsors & Collaborators

• alan apter: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel, 49100, Israel

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Avi Sadeh, Prof.

  Tel Aviv University; Schneider Children's Medical Center of Israel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of psychological medicine department at Schneider; Professor at Sackler School of medicine

Study Record Dates

• First Submitted: July 3, 2011
• First Posted: July 13, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

IL (1)