A Clinical Research Studying Interventions for Nighttime Fears in Preschool Children

NCT ID: NCT01393691

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CBT with parent combined play

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.

Group Type: EXPERIMENTAL

CBT with parent involved play

Intervention Type: 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.

Triadic expressive play therapy

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

Group Type: ACTIVE_COMPARATOR

Triadic expressive play therapy

Intervention Type: BEHAVIORAL

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

Interventions

CBT with parent involved play

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.

Intervention Type: BEHAVIORAL

Triadic expressive play therapy

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

alan apter

OTHER

Sponsor Role: lead

Responsible Party

alan apter

Director of psychological medicine department at Schneider; Professor at Sackler School of medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Avi Sadeh, Prof.

Role: STUDY_DIRECTOR

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

Locations

Rabin Medical Center

Petah Tikva, Israel, Israel

Countries

Israel

Other Identifiers

6191

Identifier Type: -

Identifier Source: org_study_id