Nighttime FearsNCT01393691
A Clinical Research Studying Interventions for Nighttime Fears in Preschool Children
A study testing CBT with parent involved play and Triadic expressive play therapy in people with Nighttime Fears, run by alan apter at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Nighttime Fears
- What is being tested?
- CBT with parent involved play and Triadic expressive play therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- major health or neurological-developmental problems
- concurrent psychiatric treatment
- concurrent psychotherapy or any other intervention aimed at reducing the child's nighttime fears.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nighttime Fears
- Being tested
- CBT with parent involved play, Triadic expressive play therapy
- Keywords
- nighttime fears, anxiety, sleep, actigraphy, intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT with parent involved playBehavioural
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 therapyBehavioural
Based on expressive play therapy guidelines, children and their parents will express themes concerning bedtime routines and fears via play.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Triadic expressive play therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week -6months
Secondary outcomes (1)
Activity-based sleep monitoring (Actigraphy)
The actigraph is a wristwatch-like device attached to the child's wrist, which enables continuous recording of the child's movements for extended periods, with no interference with the child's natural sleep environment.
The following actigraphic sleep measures will be included in this study: (a) sleep onset time (b) total sleep duration from sleep onset to morning rising time; (c) morning rising time; (d) sleep percentage; (e) true sleep time; and (f) number of night-wakings.
Measured: 1 week- 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nighttime FearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- alan apter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, alan apter, Rabin Medical Center
- Investigators
- Avi Sadeh, Prof., Study director, Tel Aviv University; Schneider Children's Medical Center of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393691
- Sponsor's protocol ID
- 6191
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2011
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Nighttime Fears in Preschool Children: Assessment of Predictors and Outcomes
- ClinicalTrials.gov ID
- NCT01393691
- Acronym / sponsor ID
- 6191
- Conditions
- Nighttime Fears
- Keywords
- nighttime fears, anxiety, sleep, actigraphy, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- alan apterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT with parent combined play | Experimental | Behavioral: CBT with parent involved playThis 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 | Active comparator | Behavioral: Triadic expressive play therapyBased on expressive play therapy guidelines, children and their parents will express themes concerning bedtime routines and fears via play. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- major health or neurological-developmental problems
- concurrent psychiatric treatment
- concurrent psychotherapy or any other intervention aimed at reducing the child's nighttime fears.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT with parent involved playThis 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. | Behavioural | CBT with parent combined play |
| Triadic expressive play therapyBased on expressive play therapy guidelines, children and their parents will express themes concerning bedtime routines and fears via play. | Behavioural | Triadic expressive play therapy |
Primary outcome
nighttime fear and sleep logs
Time frame: 1 week- 6 months
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.
Nighttime fears interview (child) and nighttime fears questionnaire (parents)
Time frame: 1 week -6months
Children will be interviewed regarding the content, frequency and severity of their nighttime fears. Parents will complete a questionnaire regarding these issues.
1 secondary outcome
Activity-based sleep monitoring (Actigraphy)
Time frame: 1 week- 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Sadeh, Prof. study director
Tel Aviv University; Schneider Children's Medical Center of Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT with parent involved play and Triadic expressive play therapy in people with Nighttime Fears, run by alan apter at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nighttime fear and sleep logs (time frame: 1 week- 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.