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Trial registered on ANZCTR

Registration number

ACTRN12618000290291

Ethics application status

Approved

Date submitted

6/02/2018

Date registered

26/02/2018

Date last updated

20/03/2020

Date data sharing statement initially provided

30/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluating the Therapist-assisted Online Parenting Strategies (TOPS) program on anxiety, depression and sleep in adolescents aged 12 to 18 years.

Scientific title

Effects of an online parenting program with telephone coaching (Therapist-assisted Online Parenting Strategies) on anxiety, depression and sleep outcomes of 12-18 year-olds with anxiety and depression: A single-armed uncontrolled open-label trial.

Secondary ID [1]

NIL

Universal Trial Number (UTN)

U1111-1206-3980

Trial acronym

Linked study record

ACTRN12615000247572

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Sleep problems

Suicidal ideation

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This individualized intervention is comprised of two parts:
1) a web-based component drawn from the Partners in Parenting intervention (refer to ACTRN12615000247572) which includes a once-off individually-tailored feedback report on the parent's parenting practices and up to nine weekly web-based modules (each taking 15-25 minutes to complete); and, 2) a coaching component delivered via web-conference or telephone, henceforth known as Therapist-assisted Online Parenting Strategies (TOPS) sessions, one session accompanying each web-based module, each taking 30-45 minutes.

The web-based component will be composed of 9-modules, covering areas of 1) the parent’s relationship with their teen, 2) parental involvement, 3) encouraging their teen to develop supportive relationships with friends, 4) establishing family rules, 5) minimising conflict in the home environment, 6) health habits covering diet, physical activity, sleep habits and abstinence from alcohol and drugs, 7) strategies for parents to help deal with their teen’s problems, 8) strategies for parents to help their teen manage their anxiety, and 9) seeking additional professional help.

Supplemented TOPS sessions will be run in the trial, aligned with material from the Partners in Parenting program. The TOPS sessions contain more expansive content for parents to reinforce learning and allow them the opportunity to clarify the material provided on the website. Discussions around goal setting and enabling goal attainment are also a focus of these sessions. The material developed to enhance the online-content is visually presented through online teleconferencing during the TOPS coaching session. Annotated copies of the presentation will be provided as soft-copy and emailed to the parent at the end of the TOPS session. TOPS sessions are manualised so that coaches standardize delivery of the protocol. TOPS coaches are at minimum post-graduate psychology students undertaking training in a Doctorate or Masters in Psychology (Clinical or Educational and Developmental).

Parents will first complete two baseline surveys of the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breen, Jorm, Lawrence, Mackinnon, & Yap, 2017) that assesses their current parenting practices against the recommendations in the Guidelines 'How to reduce your child's risk of depression and clinical anxiety in your teenager' (Yap, Martin, & Jorm, 2017; henceforth the Guidelines). Based on their responses to the second baseline survey that is completed approximately 1 month after registration, parents in the intervention group will then (1) receive an individually-tailored feedback report that highlights areas where they are doing well (i.e., concordant with the Guidelines) and areas where they can improve (i.e., not concordant with the Guidelines), and (2) be given access to the web-based parenting intervention (up to 9 modules) to support them in making changes to the identified areas of weakness in their parenting. Specific modules are recommended to parents based on their responses to the Parent Survey. Feedback messages will be brief, with practical strategies provided in dot point form, and are designed to motivate behaviour change. All participating parents will view their feedback report online and will also be emailed a copy of their feedback report.

The participating parent will be invited to attend an orientation session within 1 month of registering but prior to completion of the second baseline survey. This session is aimed at enabling the parent participant to log-in to the intervention website, to engage with the online modules and to become familiarised with the web-conference coaching process. No intervention material or psychoeducation content will be presented to participants at this stage.

Immediately after the parent participant completes the second baseline survey, he/she will be emailed instructions for accessing the interactive parenting program. When parents log in to their parenting program, he/she will see their recommended modules as well as the remaining modules that have not been allocated. Parents can further tailor their parenting program at this stage by deselecting recommended modules and/or selecting additional modules. They then confirm their selection and can commence their personalised program.

The 9 modules comprising the intervention are derived from topics covered in the Guidelines. Modules include illustrations, vignettes, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. The module topics include:
1) Establishing and maintaining a good relationship with your teenager
2) Being involved and supporting increasing autonomy
3) Encouraging supportive relationships
4) Establishing family rules and consequences
5) Minimising conflict in the home
6) Encouraging good health habits (diet, physical activity, sleep and abstinence from alcohol or drugs)
7) Helping your teenager to deal with problems
8) Helping your teenager to deal with anxiety
9) Professional help-seeking when needed

Trained coaches will unlock online modules progressively for parents after they have completed the previous module and received a follow-up TOPS coaching session at a time appointed by the parent. Online modules will take approximately 15 to 25 minutes to complete while the conference call-coaching sessions are anticipated to take between 30 and 45 minutes. TOPS-coaches will review goal setting or the successful application of new skills, respond to questions, and provide encouragement. Adolescents will not participate in coaching calls or access the website. The intervention period is anticipated to run for 4 months while the adolescent continues to receive standard psychological care externally. Although the online component consists of only 9-modules, up to 13 telephone coaching sessions will be offered to parents through an expanded "Encouraging good health habits" module, covering each health habit of diet, physical activity, sleep and abstinence from alcohol or drugs, over 4 weeks. Parents are encouraged to complete one module per week. Once parents have completed all the modules in their personalised program, they have ongoing access to all 12 modules in the program. Their access to their parenting program will remain open indefinitely.

Retention of participants will be aided by follow-up phone calls to parents who have not booked in their TOPS session within a 2-week period. Trained research assistants with currently enrolment status in an undergraduate degree majoring in Psychology will follow-up calls using a standardised script.

Outcomes will be assessed through parent and adolescent online surveys completed at the two baseline timepoints (at enrolment, Day 0; and on Day 30), at post-intervention (4 months from the parent commencing the intervention) and at follow-up (12 months from the parent commencing the intervention).

Consent for adolescent participation will be provided by parents during registration or if adolescents turn 18 during the trial, consent will be obtained from the teen separately prior to their continued participation in the trial. Research assistants will then contact adolescents by phone to initiate completion of the adolescent-version surveys where they will be provided with separate logins and passwords. Adolescents will be guided through using Qualtrics to complete the survey and encouraged to complete this survey (except for the sleep diary component) in one sitting. Where they are unable to do so in one sitting, reminder emails or SMS will be sent to the adolescent, if required follow-up by another phone call within a 7-day period. At all time points, adolescents will be requested to complete the survey (or opt out of doing so if they do not wish to participate) before the parents are asked to do the same, with a maximum period of a one-week difference allowed between parent and adolescent survey completion.

References:
Cardamone-Breen, M. C., Jorm, A. F., Lawrence, K. A., Mackinnon, A. J., & Yap, M. B. (2017). The Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders. PeerJ, 5, e3825.

Yap, M. B. H., Martin, P. D., & Jorm, A. F. (2017). Online parenting guidelines to prevent adolescent depression and anxiety: Evaluating user characteristics and usefulness. Early Intervention in Psychiatry.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in parental concordance with the Parenting Guidelines scores measured by parent-report on the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS) from baseline to post-intervention, and follow-up. The survey consists of 83 questions and is a criterion-referenced measure assessing parents' current parenting knowledge and behaviours against specific recommendations in the Guidelines.

References:
Cardamone-Breen, M. C., Jorm, A. F., Lawrence, K. A., Mackinnon, A. J., & Yap, M. B. (2017). The Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders. PeerJ, 5, e3825.

Timepoint [1]

1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention; primary timepoint)
4) 12-months from the intervention commencement date (Follow-up)

Primary outcome [2]

Adolescent depression

Change in depression levels measured by total scores on adolescent-report version of the 13-item Short Mood and Feelings Questionnaire (SMFQ; Angold, Costello, Messer, & Pickles, 1995). Items are based on the respondents' experiences in the past two weeks, scored on a scale of 0 to 2, “not true”, “sometimes” and “always” respectively. The total score is the sum of all 13 items. Higher scores indicate higher levels of depressive symptoms.

Reference:
Angold, A., Costello, E. J., Messer, S. C., & Pickles, A. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research, 5(4), 237-249.

Timepoint [2]

1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up; primary timepoint)

Primary outcome [3]

Adolescent Anxiety
Changes in anxiety levels measured by adolescent-report version of the Spence Children's Anxiety Scale (SCAS). The SCAS (Spence, 1998) is a 44-item questionnaire that measures anxiety symptoms across 6 disorders described in the DSM-IV-TR (American Psychiatric Association, 2000); generalised anxiety disorder (6 items; e.g. “I worry about things”); separation anxiety disorder (6 items; e.g. “I would feel afraid of being on my own at home”); social phobia (6 items; e.g. “I worry what other people think of me”); panic disorder and agoraphobia (9 items; “I suddenly feel as if I can’t breathe when there is no reason for this”); and, obsessive-compulsive disorder (6 items; e.g. “I have to think of special thoughts to stop bad things from happening (like numbers or words)”). Fear of physical injury replaces specific phobias in this questionnaire and is composed of 5 items, e.g. “I am scared of dogs”. Six remaining items do not contribute to overall scoring, and serve as fillers to reduce negative response bias. Items are scored on a scale of 0 to 3; “never”, “sometimes”, “often”, or “always” respectively. Sum scores of relevant items form individual subscale scores and a total anxiety score is computed by summing all items in the questionnaire (range = [0, 114]). Higher scores indicate higher levels of anxiety.

Reference:
Spence, S. H. (1998). A measure of anxiety symptoms among children. Behaviour Research And Therapy, 36(5), 545-566. doi:10.1016/S0005-7967(98)00034-5

Timepoint [3]

1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up; primary timepoint)

Secondary outcome [1]

Changes to carer burden experienced by the parent as objective or subjective consequences, through the Burden of Assessment Scale (BAS; Reinhard & Horwitz, 1992).

The BAS contains 19 items; 10 items assess objective (observable) burden including financial problems or distress, limitations to social interaction and personal activity; 9 items measure subjective feelings, attitudes, and emotions expressed about the caregiving experiences. Items are scored on 4-point Likert scale and summed to obtain an overall score ranging from 19 to 76, with higher scores indicating greater levels of burden.

References:
Reinhard, S. C., Gubman, G. D., Horwitz, A. V., & Minsky, S. (1994). Burden assessment scale for families of the seriously mentally ill. Evaluation and program planning, 17(3), 261-269.

Timepoint [1]

1) At recruitment (Baseline 1)
2) 1 month after recruitment (Baseline 2)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)

Secondary outcome [2]

Changes to general family functioning will be measured by the General Functioning subscale of the McMaster Family Assessment Device (FAD-GF), reported independently by parent and adolescent.

The FAD-GF is a 12-item subscale that measures general functioning of the family across the six dimensions of the McMaster Model of family functioning (Epstein, Baldwin, & Bishop, 1983). Participants use a 4-point response scale (strongly agree, agree, disagree and strongly disagree) to describe how well each statement describes their family. The mean score of the 14 items is calculated, after reversing scores for negatively worded items to give an overall scale score of 1 (best functioning) to 4 (worse functioning).

References:
Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster family assessment device. Journal of marital and family therapy, 9(2), 171-180.

Timepoint [2]

Secondary outcome [3]

Changes to parent-adolescent attachment measured by the Inventory of Parent and Peer Attachment (IPPA) across three domains; mutual trust, communication quality and extent of relationship alienation (Armsden & Greenberg, 1987). Only the parent-attachment section of the survey will be completed, with reports from both parent and adolescent.

Subscales for the three domains are calculated by summing the domain-relevant items, after reversing scores for negatively worded statements. The total score for the parent attachment scale is calculated by adding the trust and communication subscale scores and then subtracting the alienation subscale score, with higher scores indicating higher attachment security.

Armsden, G. C., & Greenberg, M. T. (1987). The Inventory of Parent and Peer Attachment: Individual differences and their relationship to psychological well-being in adolescence. Journal of Youth and Adolescence, 16(5), 427-454.

Timepoint [3]

Secondary outcome [4]

Changes to the quality of sleep measured by adolescent report of the PROMIS® Pediatric Sleep Disturbance SF-8 (PROMIS-D).

The PROMIS-D assesses perceptions of sleep quality, sleep depth and restoration associated with sleep, over the past 7 days. It consists of 8 items, is non-disease specific and only assesses for sleep quality outcomes. Items are scored on a Likert scale of 1 (never) to 5 (always) except for one item, “I slept through the night”, which is reversed scored. The total raw scores are calculated for each measure and converted to a T-score (M=50, SD =10) using a table of normed scores (Meltzer, personal communication, July 7, 2017).

Timepoint [4]

Secondary outcome [5]

Changes to sleep hygiene or sleep practices known to affect the quality of sleep measured by adolescent report of a modified PROMIS® Pediatric Sleep Practices (PROMIS-P). Seven questions around bedtime regulation and use of technology before bed are asked; all items unrelated to bedtime regulation scored on a 5-point Likert scale of 1 (never) to 5 (always) and items related to bedtime regulation are reversed scored.

To account for other known sleep hygiene factors associated with poor sleep, additional questions will be asked about caffeine, alcohol and medication use, as well as their napping practices. Scoring for these questions will initially be dichotomised 0 (No) and 1 (Yes). When all items are summed, higher scores indicate poorer sleep practices.

Timepoint [5]

Secondary outcome [6]

Changes to chronotype or sleep phase measured by the Composite of Morningness scale as reported by adolescents (CSM).

The CSM consist of 13 questions to assess the individual’s optimal time-of-day functioning preferences for physical and mental activity, and subjective alertness; 3 items (1, 2 and 7) are scored on a scale of 1 to 5 with remaining questions scored from 1 to 4. All items except for 3, 4, 5 and 11 are reversed scored. Items are summed to give a total score ranging from 13 (extreme eveningness) to 55 (extreme morningness; Smith, Reilly, & Midkiff, 1989).

Reference:
Smith, C. S., Reilly, C., & Midkiff, K. (1989). Evaluation of three circadian rhythm questionnaires with suggestions for an improved measure of morningness. Journal of Applied Psychology, 74(5), 728-738. doi:10.1037/0021-9010.74.5.728

Timepoint [6]

Secondary outcome [7]

Changes to adolescent self-report scores of the Suicidal Ideation Questionnaire-Junior High School Version (SIQ-JR). This is a 15 item self-report questionnaire designed to measure current suicidal ideation. The measure uses a seven-point scale, ranging from “I never had this thought” to “Almost every day”, to assess the frequency of suicidal thoughts. Scores range from 0 to 90 and a score of 31 or above has been found to be indicative of a significant level of suicidal ideation and worthy of further evaluation (Reynolds, 1988).

Reynolds, W. M. (1988). SIQ, Suicidal ideation questionnaire: Professional manual. Psychological Assessment Resources.

Timepoint [7]