The DreamChanger Intervention in Combination With Imagery Rehearsal Therapy for Children's Nightmares

NCT06410118 | Active Not Recruiting

• 1 other identifier: 0008185-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will test the efficacy of parent-delivered DreamChanger Intervention in combination with Imagery Rehearsal Therapy (IRT) for reducing the frequency and severity of nightmares in children aged 3-10. Children will be randoimized to either the combined intervention or to a waitlist control group.The intervention will include providing children with the DreamChanger remote, and providing parents with instructional videos, explaining how to use the device along with the IRT strategy to address nightmares. At baseline, mid-treatment, and post-treatment, parents in both groups will complete questionnaires asking about the child's nightmares, sleep, externalizing and internalizing symptoms, PTSD symptoms, demographic characteristics, and parent sleep and distress. Parents in the intervention group will also be asked to complete questionnaires regarding their compliance and satisfaction with the intervention, as well as a 3-month follow-up assessment.

Conditions

Nightmare

Outcome Measures

Primary Outcomes (1)

• Nightmare frequency and severity

  Nightmare severity, frequency and related distress, as assessed using a modified version of the Nightmare Disorder Index

  Baseline, mid-treatment (2 weeks following baseline), post-treatment (4 weeks following baseline), and at a 3-month follow up

Secondary Outcomes (3)

• Child sleep problems

  Baseline, mid-treatment (2 weeks following baseline), post-treatment (4 weeks following baseline), and at a 3-month follow up

• Child externalizing and internalizing problems

  Baseline, post-treatment (4 weeks following baseline), and at a 3-month follow up

• Parent distress

  Baseline, post-treatment (4 weeks following baseline), and at a 3-month follow up

Other Outcomes (1)

• Parent compliance and satisfaction with the intervention

  Mid-treatment and post-treatment (4 weeks following baseline)

Study Arms (2)

DreamChanger combined with Imagery Rehearsal Therapy

EXPERIMENTAL

Families will receive the DreamChanger remote along with 3 instructional videos for parents, explaining how to present the remote to children, and how to rehearse alternative dream imagery using the DreamChanger remote.

Behavioral: DreamChanger+IRT

Waitlist control

NO INTERVENTION

Families will be placed on a waitlist, and receive the intervention 6 weeks after baseline

Interventions

DreamChanger+IRT BEHAVIORAL

Families will receive the DreamChanger remote along with 3 instructional videos for parents, explaining how to present the remote to children, and how to rehearse alternative dream imagery using the DreamChanger remote.

DreamChanger combined with Imagery Rehearsal Therapy

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• child aged 3-10 years
• parents aged over 18 years
• child experiencing distressing nightmares at least once per week on average, for at least 1 month.

You may not qualify if:

• Child receiving concurrent treatment for nightmares, sleep, or anxiety
• Child diagnosed with a medical sleep problem (e.g., OSA, RLS)

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel, Israel

Location

Study Officials

• Michal Kahn, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Model Details: The intervention group will be compared to a waitlist control group.

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 10, 2024
• Study Start: May 7, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)