Trial no.:	PACTR202208559723690	Date of Approval:	08/08/2022
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

SAASI

Official scientific title

South African Adolescence Sleep Intervention – SAASI

Brief summary describing the background and objectives of the trial

Posttraumatic Stress Disorder is common after trauma which is often associated with sleep disturbances. The primary aims of the current study are to assess the feasibility and effectiveness of delivering the TranS-C-Youth intervention to adolescents in South Africa. This will be achieved through the following objectives: 1. Examining the impact of TranS-C-Youth on sleep quality and symptoms of PTSD in adolescents. This will be evaluated by examining self-report data pre-, during- and post-intervention both within and between the control and intervention groups. The impact of the intervention will also be evaluated by examining parent and teacher self-report data on adolescent emotional and behavioural symptoms pre- and post-intervention. 2. Examining change in saliva cortisol concentrations as a biological marker of neuroendocrine status and intervention effect. 3. Conducting focus groups with adolescents who have received the TranS-C-Youth intervention as well as the parents and teachers of adolescents who completed the intervention, to evaluate their experience of participating in the intervention. 4. Conducting focus groups with interventionists after they have been trained and delivered the TranS-C-Youth intervention (Both their training and their experience of delivering the CBT-I will be evaluated) in order to assess the feasibility of ‘task shifting’.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Mental and Behavioural Disorders

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

01/05/2022

Actual trial start date

23/05/2022

Anticipated date of last follow up

31/12/2023

Actual Last follow-up date

Anticipated target sample size (number of participants)

64

Actual target sample size (number of participants)

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Allocation was determined by the holder of the sequence who is situated off site	Masking/blinding used	Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Control	5 group sessions (8 participants per group x 4 control groups)	Approximately 1 - 2 hours per session	Repeated assessments and completion of a sleep diary	8	Active-Treatment of Control Group
Experimental Group	Intervention group	1 individual and 4 group sessions (once a weeks for 5 weeks) (4 intervention groups of 8 participants each)	1 - 2 hours each	Youth version of the Transdiagnostic Sleep and Circadian Intervention (TranS-C-Youth), developed by Harvey (2016), adapted to the South African context. The TranS-C-Youth is based on the principles of three evidence-based sleep interventions: (1) Cognitive Behaviour Therapy for Insomnia (CBT-I); (2) timed light exposure and planned and regular sleep schedules often utilized in interventions for the Delayed sleep phase disorder; and (3) Interpersonal and Social Rhythms Therapy (IPSRT). The intervention will take place over 5 x weekly sessions.	8

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Inclusion: Adolescents aged between15 and 19 years who have experienced at least one traumatic event, and meet criteria for PTSD or for subclinical PTSD and experience sleeping difficulties.	Exclusion: Adolescents with known global cognitive disability or who have commenced pharmacological treatment in the last 4 weeks, initiated electroconvulsive therapies and/or transcranial magnetic stimulation in the last 3-months or started structured psychotherapy for PTSD in the last 3 months. Adolescents with a history of traumatic brain injury and lasting medical and/or psychological symptoms will also be excluded.	Adolescent: 13 Year-18 Year	15 Year(s)	19 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

22/02/2022

SUN HREC2

Ethics Committee Address
Street address	City	Postal code	Country
Francie van Zyl Drive	Cape Town	7505	South Africa

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	PTSD (Child PTSD Symptom Scale - self-report version for DSM-5) and Sleep (Pittsburgh Sleep Quality Index)	baseline, midpoint, post-intervention and 30-days post-intervention
Secondary Outcome	Anxiety (Multidimensional Anxiety Scale for Children), Depression (Kutcher Adolescent Depression Scale-6), Sleep Quality (Adolescent Sleep Wake Scale), Sleep disturbances (Fear of Sleep Inventory), Insomnia (Insomnia Severity Index), Alcohol use (Alcohol Use Disorders Identification Test), Drug use (Drug Use Disorders Identification Test), Emotional and behavioural strengths and difficulties (Strengths and Difficulties Questionnaire)	baseline, midpoint, post-intervention and 30-days post-intervention

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Department of Psychiatry	Stellenbosch University Faculty of Medicine and Health Sciences, Tygerberg.	Cape Town	7505	South Africa

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Ulster University	Ulster University, Cromore Rd	Coleraine	BT52 1SA	United Kingdom
National Research Foundation South African Research Chairs Initiative in PTSD	NRF Building South Gate CSIR Complex	Pretoria	0001	South Africa

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Stellenbosch University Department of Psychiatry	Francie van Zyl Drive	Cape Town	7575	South Africa	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Soraya Seedat	sseedat@sun.ac.za	+27219389161	Francie van Zyl Drive
City	Postal code	Country	Position/Affiliation
Cape Town	7505	South Africa	HoD Department of Psychiatry Stellenbosch University
Role	Name	Email	Phone	Street address
Scientific Enquiries	Sharain Suliman	sharain@sun.ac.za	+27219389161	Francie van Zyl Drive
City	Postal code	Country	Position/Affiliation
Cape Town	7505	South Africa	Senior Research Department of Psychiatry Stellenbosch University
Role	Name	Email	Phone	Street address
Public Enquiries	Alexandra Goldberg	alexgoldberg@sun.ac.za	+27219389162	Francie van Zyl Drive
City	Postal code	Country	Position/Affiliation
Cape Town	7505	South Africa	Research Assistant

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Yes: There is a plan to make IPD and related data dictionaries available	Informed Consent Form,Statistical Analysis Plan,Study Protocol	Within 24 months of study completion	Available upon reasonable request
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry