|- candidate number||19530|
|- NTR Number||NTR4803|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-sep-2014|
|- Secondary IDs||2014-CDE-3752 |
|- Public Title||The online intervention The Growth Factory: developing a growth mindset!|
|- Scientific Title||A randomized pilot trial of the online intervention The Growth Factory for youth with psychiatric problems and/or intellectual disability: the impact on change beliefs, coping, empowerment, self-worth and internalizing and externalizing problems.|
|- hypothesis||We expect youth in the intervention group to show greater improvements in change beliefs, empowerment, coping and self-worth and greater reductions internalizing and externalizing problems in comparison to youth in the control group.|
|- Healt Condition(s) or Problem(s) studied||Psychiatric disorders, Coping, Behavioral problems, Intellectual disabillities|
|- Inclusion criteria||- Participants attend a special school for students with learning disabilities and/or psychiatric problems|
- Participants are 12-19 years
- Participants and parental consent are required
|- Exclusion criteria||- Participant experiences extreme aggressive behavior|
- Participant experiences acute severe psychological problems
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||3-sep-2014|
|- planned closingdate||1-jun-2015|
|- Target number of participants||60|
|- Interventions||The online intervention The Growth Factory is based on the scientific research on the incremental theory by Caroll Dweck and David Yeager. Implicit theories about intelligence and personality form the basis for The Growth Factory. On the one hand we have the fixed theory. With a fixed mindset, people consider personality, competence and intelligence to be static. They think that people cannot really change. On the other hand we have the ‘incremental change theory’. People who have a growth mindset believe that as a person you can change, grow and develop. With a growth mindset, people consider personality, competence and intelligence to be malleable.
The aim of The Growth Factory is to teach youth an incremental theory in which feelings, behaviors and abilities are conceptualized as malleable. Youth learn for example that our brain is always in development and by training new connections are built or existing connections get stronger. Youth learn to face effort, adversity and feedback as an opportunity for development. Youth also learn to use the growth formula: effort + correct strategy + help from others and learn to change negative thoughts into positive thoughts (i.e. growth thoughts).
Participants in the intervention group participate in six sessions of the ‘The Growth Factory’. After 3-months youth will receive a booster session repeating the content of the Growht Factory. A session takes 20-30 minutes. The Growth Factory is innovative as it uses an online approach. By using an online intervention we could adapt to the information processing needs of youth with intellectual disabilities, such as visualization, structure and adjust to their experiences.
The structure of each session is:
- an introduction by an individually chosen buddy with a summary of the previous session and an introduction to today’s topic;
- an animation clip explaining the content of the session together with the possibility of repetition of the same animation clip;
- two interactive assignments followed by a summary provided by the buddy and a mentioning of next week’s topic.
Youth will receive two short messages by text- or mail during the week after each session with a reminder or assignment. This will help them to make the transfer from the online session to daily life.
The sessions will take place at school during school time on a laptop or computer. Participants follow each session individually and are assisted by a trainer. Youth work on the intervention as independently as possible but receive as much support as needed from the trainer.
Participants are randomized into the intervention group or control group using stratified randomization based on gender, age and intelligence. Both the intervention and control group have full access to usual mental and/or physical care. The Growth Factory should be seen as add-on intervention, strengthening usual care, not substituting usual care. If The Growth Factory shows to be effective, in this randomized pilot trial, all youth in the control group will be provided the opportunity to participate in The Growth Factory after the study is completed.
|- Primary outcome||- Change Beliefs (Change Beliefs Questionnaire (CBQ), Verberg et al, in preparation). |
|- Secondary outcome||- Coping strategies (Cognitive Emotion Regulation Questionnaire (CERQ), Garnefski & Kraaij, 2006).|
- Empowerment (Empowerment vragenlijst (EMPO), Damen & Veerman, 2011).
- Self-worth (Rosenberg self-esteem scale, Greenberger et al., 2003).
- Internalizing and externalizing problems (Brief Problem Monitor (BPM-Y), Achenbach et al.,2011).
|- Timepoints||T1: Pretest (Sep '14)|
T2: Posttest – after session 6 (Nov/Dec '14)
T3: Three months after session 6 (Feb '15)
T4: Six months after session 6 (May '15)
|- Trial web site||www.degroeifabriek.nl|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES|| F. Verberg|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P. Helmond|
|- Sponsor/Initiator ||Pluryn Research & Development|
(Source(s) of Monetary or Material Support)
|- Brief summary||The aim of this study is to test the effectiveness of the online intervention ‘The Growth Factory’ in a target group of youth with psychiatric problems and/or intellectual disabilities (12-19 years). The Growth Factory teaches youth an incremental theory in which feelings, behaviors and abilities are conceptualized as malleable. The Growth Factory is a short online intervention with six-sessions and a booster session. Each session takes about 20-30 minutes. Youth are recruited from a special education school for youth with learning disabilities and psychiatric problems in The Netherlands. We expect youth in the intervention group (N=30) to show greater improvements in change beliefs, empowerment, coping and self-worth and greater reductions internalizing and externalizing problems in comparison to youth in the control group (N=30). Measurements take place at pretest, posttest and follow-up after 3 months and 6 months. |
|- Main changes (audit trail)||15-okt-2014: Tijdspad: |
3 sep 2014 - 22 sep 2014: voormetingen
23 sep 2014: randomisatie
29 sep 2014: start interventie groep De Groeifabriek
1 juni 2015: einde trial (alle metingen voltooid)
|- RECORD||22-sep-2014 - 18-okt-2014|