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Augmenting behavioral interventions for infant sleep problems

Increasing Parental Cry Tolerance to Augment Behavioral Interventions for infant sleep problems

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001766101
Enrollment
40
Registered
2019-12-12
Start date
2019-12-25
Completion date
2020-11-01
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study evaluates the addition of three components (music distraction, distraction via gaming and reappraisal) designed to augment Graduated Extinction for infant sleep problems. Participants will be parents of infants with pediatric insomnia. They will be randomized into 4 groups: (1) Control group, receiving Graduated Extinction alone; (2) Music distraction group receiving Graduated Extinction with a music distraction technique; (3) Distraction via gaming group, receiving Graduated Extinction with a gaming distraction technique; and (4) Reappraisal group receiving Graduated Extinction with a reappraisal technique. Infant sleep and maternal sleep and compliance will be assessed at baseline, and 1- and 6-weeks later. Parental cry tolerance, driving performance, sleepiness and fatigue will also be assessed at these 3 time points.

Interventions

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 a

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.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
6 Months to 24 Months
Healthy volunteers
No

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.

Exclusion criteria

(1) infant pervasive developmental disorder or significant medical illness and (2) any concurrent treatment for infant sleep problems.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026