Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001766101
Ethics application status
Approved
Date submitted
5/12/2019
Date registered
12/12/2019
Date last updated
12/12/2019
Date data sharing statement initially provided
12/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Augmenting behavioral interventions for infant sleep problems
Scientific title
Increasing Parental Cry Tolerance to Augment Behavioral Interventions for infant sleep problems
Secondary ID [1] 300021 0
None
Universal Trial Number (UTN)
U1111-1244-9956
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioral Insomnia of Childhood 315521 0
Condition category
Condition code
Mental Health 313803 313803 0 0
Other mental health disorders
Neurological 313839 313839 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Graduated extinction- this behavioural technique is based on psychological learning theory. Parents are instructed to put their child to bed at night and then leave the room, and return at scheduled progressively increasing intervals (e.g. every 2 minutes, then every 3 minutes etc.) to check or reassure the infant in case he or she cries or signals distress.
The four following variations of Graduated Extinction will be compared in this study:
(1) Control group, receiving Graduated Extinction alone.
(2) Music distraction group receiving Graduated Extinction with a music distraction technique. In addition to the Graduated Extinction guidelines (i.e., delaying response to the infant at scheduled intervals to facilitate acquisition of self-soothing skills), participants in this group will be asked to listen to their choice of music during the intervals in which they wait and delay their response.
(3) Distraction via gaming group, receiving Graduated Extinction with a gaming distraction technique. In addition to the Graduated Extinction guidelines (i.e., delaying response to the infant at scheduled intervals to facilitate acquisition of self-soothing skills), participants in this group will be asked to play to their choice of game on their phone or other media screen-device during the intervals in which they wait and delay their response.
(4) Reappraisal group receiving Graduated Extinction with a reappraisal technique. In addition to the Graduated Extinction guidelines (i.e., delaying response to the infant at scheduled intervals to facilitate acquisition of self-soothing skills), during the intervals in which they wait and delay their response, participants in this group will be asked to practice telling themselves that “it’s nothing very serious, this baby is not sick or hurt, they are learning to self-soothe”.

Each of the four variations described above will be provided in two face to face sessions (45 minutes each) with a provisional or clinical psychologist (postgraduate level) at the Flinders University Child and Adolescent Sleep Clinic. The second session will be held 1 week after the first. Families will be asked to implement the interventions with their infants for all sleep episodes during the week between the first and second treatment session. During this week, they will monitor their adherence to the intervention using a daily diary.
Intervention code [1] 316292 0
Behaviour
Intervention code [2] 316318 0
Treatment: Other
Comparator / control treatment
The control group will receive Graduated Extinction alone, without an additional music distraction/gaming distraction/reappraisal component.
Graduated extinction is a behavioural technique, based on psychological learning theory. For each sleep episode throughout the day, parents will be instructed to put their child to bed and then leave the room, and return at scheduled progressively increasing intervals (e.g. every 2 minutes, then every 3 minutes etc.) to check or reassure the infant in case he or she cries or signals distress.
The intervention will be provided in two face to face sessions (45 minutes each) with a provisional or clinical psychologist (postgraduate level) at the Flinders University Child and Adolescent Sleep Clinic. The second session will be held 1 week after the first. Families will be asked to implement the intervention with their infants for all sleep episodes during the week between the first and second treatment session. During this week, they will monitor their adherence to the intervention using a daily diary.
Control group
Active

Outcomes
Primary outcome [1] 322208 0
Maternal sleep, measured using nightly diaries.
Timepoint [1] 322208 0
Assessments at baseline, and 1- and 6- weeks later. Seven consecutive nights per assessment.
Primary outcome [2] 322234 0
Maternal adherence to the intervention, measured using a nightly diary.
Timepoint [2] 322234 0
Assessments at 1- and 6-weeks after the initial treatment session. Seven consecutive nights per assessment.
Primary outcome [3] 322249 0
Infant sleep, measured nightly with diaries
Timepoint [3] 322249 0
Assessments at baseline, and 1- and 6- weeks later. Seven consecutive nights per assessment.
Secondary outcome [1] 377724 0
Infant sleep, measured using actigraphy. The following sleep metrics will be used: (1) Total sleep time; (2) Number of awakenings; (3) Duration of wake after sleep onset; (4) Sleep onset latency; (5) Sleep efficiency; (6) Duration of longest sleep period.
Timepoint [1] 377724 0
Assessments at baseline, and 1- and 6- weeks later. Seven consecutive nights per assessment.
Secondary outcome [2] 377725 0
Parental cry tolerance, measured using a brief laboratory paradigm (~8 minutes) in which participants listen to infant crying audio clips and indicate when they would intervene.
This paradigm is an adaptation of the validated Intervention Delay to Infant Crying Video (IDICV) paradigm (Sadeh A, et al. Low parental tolerance for infant crying:
an underlying factor in infant sleep problems? J Sleep Res. 2016;25(5):501–507), performed with audio only (as opposed to the video and audio clip used in the IDICV).
Timepoint [2] 377725 0
Assessments at baseline, and 1- and 6- weeks later.
Secondary outcome [3] 377726 0
Parental driving performance, measured using a laboratory driving simulation, of approximately 30 minutes. This specific paradigm has been used in previous investigations of driving performance (e.g., Bragg, Desbrow, Hall & Irwin 2017. Effect of meal glycemic load and caffeine consumption on prolonged monotonous driving performance. Physiology & Behavior 181, 110-116). The reliability and validity of laboratory driving simulation paradigms has been previously established (N. Mullen, et al. 2011.
Simulator validity: behaviours observed on the simulator and on the road
D. Fisher, et al. (Eds.), Handbook of Driving Simulation for Engineering, Medicine, and Psychology, Ringgold Inc, Portland).
Timepoint [3] 377726 0
Assessments at baseline, and 1- and 6- weeks later.
Secondary outcome [4] 377727 0
Parental self reported fatigue, measured using the Flinders Fatigue Scale (FFS).
Timepoint [4] 377727 0
Assessments at baseline, and 1- and 6- weeks later
Secondary outcome [5] 377817 0
Parental self reported sleepiness, measured using the Epworth Sleepiness Scale (ESS)
Timepoint [5] 377817 0
Assessments at baseline, and 1- and 6-weeks later

Eligibility
Key inclusion criteria
Mothers of infants (boys or girls) aged 6-24 months with sleep problems existing for at least 1 month, manifested in an average of at least 30 min sleep onset latency (SOL), at least 30 min wake after sleep onset (WASO), and/or at least 3 awakenings per night based on parent reports.
Minimum age
6 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) infant pervasive developmental disorder or significant medical illness and (2) any concurrent treatment for infant sleep problems.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/12/2019
Actual
Date of last participant enrolment
Anticipated
1/11/2020
Actual
Date of last data collection
Anticipated
18/12/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 304475 0
University
Name [1] 304475 0
Flinders University
Country [1] 304475 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park
SA 5042
Australia
Country
Australia
Secondary sponsor category [1] 304744 0
None
Name [1] 304744 0
Address [1] 304744 0
Country [1] 304744 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304906 0
Social and Behavioural Research Ethics Committee, Flinders University
Ethics committee address [1] 304906 0
Ethics committee country [1] 304906 0
Australia
Date submitted for ethics approval [1] 304906 0
08/02/2018
Approval date [1] 304906 0
13/04/2018
Ethics approval number [1] 304906 0
7928

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98606 0
Prof Michael Gradisar
Address 98606 0
Flinders University
Social Sciences North
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park
SA 5042
Country 98606 0
Australia
Phone 98606 0
+61 8 82012324
Fax 98606 0
Email 98606 0
[email protected]
Contact person for public queries
Name 98607 0
Michael Gradisar
Address 98607 0
Flinders University
Social Sciences North
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park
SA 5042
Country 98607 0
Australia
Phone 98607 0
+61 8 82012324
Fax 98607 0
Email 98607 0
[email protected]
Contact person for scientific queries
Name 98608 0
Michael Gradisar
Address 98608 0
Flinders University
Social Sciences North
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park
SA 5042
Country 98608 0
Australia
Phone 98608 0
+61 8 82012324
Fax 98608 0
Email 98608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.